A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous Fibrosclerotic Panniculopathy
Phase: PHASE2
Conditions: Edematous Fibrosclerotic Panniculopathy, Cellulite
Sponsor: Endo Pharmaceuticals



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EN3835-202 Protocol Amendment 3 
6-Jun-2017 
Endo Pharmaceuticals Inc. 
Page 3 
 
 
 
Section 
Original Text 
Revised Text 
Improvement Scale (I-GAIS), and Subject 
Global Aesthetic Improvement Scale 
(S-GAIS) 
To evaluate immunogenicity after exposure to 
EN3835 
To evaluate long-term response to EN3835 in 
assessments of EFP including subject 
satisfaction, Investigator Global Aesthetic 
Improvement Scale (I-GAIS), and Subject 
Global Aesthetic Improvement Scale 
(S-GAIS) 
To assess cellulite severity assessments in 
quadrants treated in this study with EN3835. 
To evaluate immunogenicity after exposure to 
EN3835 
4 Synopsis, 
Study Design 
Treatments will be administered on days 1, 
22, and 43; subjects will be assessed for safety 
on days 1, 22, 43, and 71 and for cellulite 
severity assessments on days 1, 43, and 71.  
Treatments will be administered on Days 1, 
22, and 43; subjects will be assessed for safety 
on Days 1, 22, 43, and 71 and for cellulite 
severity assessments at Screening visit and on 
Days 22, 43, and 71.  
4 Synopsis, 
Diagnosis and 
inclusion/ 
exclusion criteria 
Qualification for the Open-Label 
Treatment Phase of the Study 
Inclusion criteria for treatment: 
Have participated in and completed the 
double-blind study EN3835-201 and all 
day 71 assessments 
Qualification for the Open-Label 
Treatment Phase of the Study 
Inclusion criteria for treatment: 
Have participated in and completed the 
double-blind study EN3835-201  
4 Synopsis, 
Duration of study 
Follow-up: For subjects treated with EN3835 
in this study, subjects will be observed at 
treatment visits (Days 1, 22, and 43) and 
Day 71 after first injection. 
Follow-up: For subjects treated with EN3835 
in this study, subjects will be observed at 
treatment visits (Days 1, 22, and 43) and 
Day 71 after first injection. After Day 71, they 
will be observed every 3 months from their 
first exposure to EN3835 up to a maximum of 
1 year. 
5 Schedule of 
Events 
NOTE: Observation visits (Table 2) in the 
open-label extension study begin after 
completion of double-blind study (day 71). 
Treatment sessions (Table 3), if elected, will 
begin when study drug blind is broken in 
study EN3835-201 while observation visits 
continue concurrently. 
NOTE: Observation visits (Table 2) in the 
open-label extension study begin after 
completion of double-blind study (Day 71). 
Treatment sessions (Table 3), if elected, will 
begin after study drug blind is broken in study 
EN3835-201while observation visits continue 
concurrently. 
5 Schedule of 
Events, Table 2, 
Collection of 
Samples: Anti-
AUX-I/anti-
AUX-II antibody 
level 
Visit 1: X 
Visit 2: X 
Visit 3: X 
Visit 4: X 
Visit 1:  
Visit 2:  
Visit 3:  
Visit 4: X 
5 Schedule of 
Events, Table 3, 
Tx Visit 4 End of 
Treatment/Early 
Termination  
Day 71 … 
Tx Visit 4 
End of Treatment/  
Early Termination 
Day 71 (±5 days)b 
Tx Visit 4 
End of Treatment/  
Early Termination 
Day 71 (+5 days)b 

EN3835-202 Protocol Amendment 3 
6-Jun-2017 
Endo Pharmaceuticals Inc. 
Page 4 
 
 
 
Section 
Original Text 
Revised Text 
5 Schedule of 
Events, Table 3, 
Procedures  
Screening Ba: 
Medical history/EFP history including 
previous treatments: Xk 
Prior/Concomitant Medications/Procedures: 
Xk 
Physical examination: 
Body weight: X 
Height: X 
Collection of samples: 
Clinical laboratory X 
Tx Visit 1: 
Prior/Concomitant Medications/Procedures: X 
Screening Ba: 
Medical history/EFP history including 
previous treatments: Xk,m 
Prior/Concomitant Medications/Procedures: 
Xk,m 
Physical examination: 
Body weight: Xm 
Height: Xm 
Collection of samples: 
Clinical laboratory: Xm 
Tx Visit 1: 
Prior/Concomitant Medications/Procedures: 
Xm 
5 Schedule of 
Events, Table 3, 
Collection of 
Samples: Anti-
AUX-I/anti-
AUX-II antibody 
level 
Tx Visit 1: Xe 
Tx Visit 2: Xe 
Tx Visit 3: Xe 
Tx Visit 4: X  
Tx Visit 1: Xe,m 
Tx Visit 2:  
Tx Visit 3:  
Tx Visit 4: X 
5 Schedule of 
Events, Table 3, 
footnotes 
a Eligible subjects may choose additional 
treatment any time after the study drug blind 
is broken in study EN3835-201. 
Add 
a After the study drug blind is broken in study 
EN3835-201, eligible subjects may elect to 
receive EN3835 treatments. 
m Do not conduct on subjects eligible and 
opting-in for a second course of treatment in 
the current study (EN3835-202) if Screening 
B visit or Day 1 visit for second treatment 
course is the same day as Day 71 of the first 
treatment course in this study or previous 
study EN3835-201. 
9.2 Secondary 
Objectives 
To assess safety and immunogenicity of 
re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
To evaluate the durability of response to 
EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects 
previously receiving active-treatment in study 
EN3835-201 using the PR-PCSS, the 
CR-PCSS, and the Hexsel CSS 
To evaluate long-term response to EN3835 in 
assessments of EFP including subject 
satisfaction, I-GAIS, and S-GAIS 
To assess cellulite severity assessments in 
quadrants treated in this study with EN3835 
To assess safety and immunogenicity of 
re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
To evaluate the durability of response to 
EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects 
previously receiving active-treatment in study 
EN3835-201 using the PR-PCSS and the 
CR-PCSS 
To evaluate long-term response to EN3835 in 
assessments of EFP including subject 
satisfaction, I-GAIS, and S-GAIS 
To assess cellulite severity assessments in 
quadrants treated in this study with EN3835 
To evaluate immunogenicity after exposure to 
EN3835 

EN3835-202 Protocol Amendment 3 
6-Jun-2017 
Endo Pharmaceuticals Inc. 
Page 5 
 
 
 
Section 
Original Text 
Revised Text 
10.1 Study 
Design 
Following the study drug blind being broken 
and communicated to centers, treatments of 
eligible subjects with EN3835 can begin at a 
visit at the discretion of the subject. 
Following the study drug blind being broken 
and communicated to centers, eligible subjects 
may elect to receive EN3835 treatment.  
11.1 Observation 
Phase 
All subjects who have completed the double-
blind study EN3835-201, including all day 71 
assessments, and sign informed consent are 
eligible for enrollment in this open-label 
extension study and participation in the 
ongoing safety and cellulite evaluations.  
All subjects who have completed the double-
blind study EN3835-201 and sign the 
informed consent are eligible for enrollment in 
this open-label extension study and 
participation in the ongoing safety and 
cellulite evaluations.  
11.2.1 Subject 
Inclusion Criteria 
for Treatment 
Have participated in and completed the 
double-blind study EN3835-201 and all 
Day 71 assessments 
Have participated in and completed the 
double-blind study EN3835-201  
11.2.2 Subject 
Exclusion 
Criteria for 
Treatment 
Add 
Presence of any clinically relevant conditions, 
that in the opinion of the Investigator would 
interfere with completing the study including, 
but not limited to, visual problems, hearing 
problems, cognitive impairment or acute 
mental illness 
12.1.3 Study 
Entry/ 
Observational 
Assessments 
A subject who gives written informed consent 
and who satisfies all eligibility criteria 
(section 11) may be entered into the 
observational phase of the study and complete 
safety and cellulite severity assessments at 
3-month intervals as detailed in Table 2. 
A subject who gives written informed consent 
and who satisfies all eligibility criteria 
(section 11) may be entered into the 
observational phase of the study and complete 
safety and cellulite severity assessments at 
3-month intervals as detailed in Table 2. The 
first visit will be determined by the date of 
enrollment in study EN3835-202 relative to 
the Schedule of Events for Study EN3835-202 
(Table 2). For example, if a subject enrolls 
after the Day 90 visit window, the first 
observation visit for that subject would be 
Day 180. 
12.1.4 Treatment 
Assessments 
(Optional) 
If a subject received placebo in the double-
blind study, she may be eligible for 2 
treatments in the open-label study; if a subject 
received active drug in the double-blind study, 
she may be eligible for 1 additional treatment 
(3 treatment sessions) in the open-label study.  
If a subject received placebo in the double-
blind study, she may be eligible for 2 
treatment courses in the open-label study; if a 
subject received active drug in the 
double-blind study, she may be eligible for 1 
additional treatment course (3 treatment 
sessions) in the open-label study.  
12.1.4 Treatment 
Assessments 
(Optional), 
Selection of 
Treatment 
Quadrant 
The Investigator will then assess each of the 4 
subject’s quadrants live in real-time using the 
CR-PCSS.  
The Investigator will then assess each of the 
subject’s 4 quadrants live in real-time using 
the CR-PCSS.  

EN3835-202 Protocol Amendment 3 
6-Jun-2017 
Endo Pharmaceuticals Inc. 
Page 6 
 
 
 
Section 
Original Text 
Revised Text 
12.1.4 Treatment 
Assessments 
(Optional), 
Selection of 
Treatment 
Quadrant 
A subject who received placebo in the double-
blind study may be treated in the same 
quadrant in the open-label study if the 
quadrant still meets all 3 criteria OR another 
qualifying quadrant may be selected for 
treatment by the Investigator and subject.  
A subject who received placebo in the double-
blind study may be treated in the same 
quadrant in the open-label study if the 
quadrant still meets all 3 criteria OR another 
qualifying quadrant may be selected for 
treatment by the subject.  
12.1.4 Treatment 
Assessments 
(Optional), 
Selecting and 
Marking 
Dimples 
The cellulite severity assessments using the 
PR-PCSS, CR-PCSS, and Hexsel CSS will be 
completed prior to dimple marking at 
treatment visits 2, 3, and 4/end of treatment. 
The cellulite severity assessments using the 
PR-PCSS and CR-PCSS will be completed 
prior to dimple marking at treatment visits 2, 
3, and 4/end of treatment. 
12.1.4.1 
Screening B 
'D\VíWRí
Relative to 
Open-Label 
Treatment Visit 
Day 1) 
The Investigator will conduct live assessments 
of subject’s cellulite severity of each quadrant 
using the CR-PCSS (section 13.1.1.4) 
The Investigator will conduct independent live 
assessments of subject’s cellulite severity of 
each quadrant using the CR-PCSS 
(section 13.1.1.4) after the subject completes 
her ratings and with no knowledge of the 
subject's ratings of her quadrants. 
12.1.4.1 
Screening B 
'D\VíWRí
Relative to 
Open-Label 
Treatment Visit 
Day 1) 
Collection of samples for: 
Clinical laboratory testing including 
Anti-AUX-I and anti-AUX-II antibody testing 
(section 14.7) 
Urine pregnancy testing (section 14.7) 
Collection of samples for: 
Clinical laboratory testing (section 14.7) 
Urine pregnancy testing (section 14.7) 
12.1.4.2, 
Treatment 
Session 1 … 
Treatment Session 1 (Visit 1B) 
Treatment Session 1 (Treatment Visit 1) 
12.1.4.2 
Treatment 
Session 1 …, 
Pre-injection 
Collection of samples for urine pregnancy 
testing (section 14.7) 
Collection of samples for:  
anti-AUX-I and anti-AUX-II antibody testing 
(section 14.7.1) 
urine pregnancy testing (section 14.7) 
12.1.4.3, 
Treatment 
Session 2 … and 
Treatment 
Session 3 … 
Treatment Session 2 (Visit 2/Day 22 ± 
3 Days) and Treatment Session 3 
(Visit 3/Day 43 ± 3 Days) 
Treatment Session 2 (Treatment Visit 2/ 
Day 22 ± 3 Days) and Treatment Session 3 
(Treatment Visit 3/Day 43 ± 3 Days) 
12.1.4.3  
Treatment 
Session 2 … and 
Treatment 
Session 3 …, 
Pre-injection 
Investigator live assessment of the severity of 
cellulite using the CR-PCSS (section 13.1.1.4) 
Investigator will conduct an independent live 
assessment of the severity of cellulite using 
the CR-PCSS (section 13.1.1.4). The 
investigator will conduct the assessment of 
severity only after the subject has completed 
her rating of her quadrant and without 
knowledge of the subject's rating of her 
quadrant. 

EN3835-202 Protocol Amendment 3 
6-Jun-2017 
Endo Pharmaceuticals Inc. 
Page 8 
 
 
 
Section 
Original Text 
Revised Text 
14.7 Clinical 
Laboratory and 
Immunogenicity 
Determinations  
Urine pregnancy test kits will be supplied by 
the Sponsor. 
DELETED TEXT 
14.7.1 Anti-
AUX-I and Anti-
AUX-II 
Antibodies 
Serum samples will be collected and may be 
tested for binding and neutralizing anti-AUX-I 
and anti-AUX-II antibodies at visit 1 through 
visit 4. Additionally, if a subject consents to 
treatment in the open-label study, serum 
samples for antibody testing will be collected 
before injection at treatment visits 1, 2, 3, and 
4 of the open-label treatment period. A subset 
of subject samples will have neutralizing 
antibodies tested from day 1 and day 71 visits; 
additional samples may be analyzed if results 
or clinical signs warrant testing. 
Serum samples will be collected and may be 
tested for binding and neutralizing anti-AUX-I 
and anti-AUX-II antibodies at visit 1 and 
visit 4. Additionally, if a subject consents to 
treatment in the open-label study, serum 
samples for antibody testing will be collected 
before injection at treatment visit 1 and at end 
of treatment/ early termination visit 4 of the 
open-label treatment period. A subset of 
subject samples may have neutralizing 
antibodies tested from Day 1 and Day 71 
visits; additional samples may be analyzed if 
results or clinical signs warrant testing.  
14.8 Vital Signs 
These parameters include pulse rate, 
respiratory rate, systolic and diastolic blood 
pressure, and body weight. 
These parameters include pulse rate, 
respiratory rate, systolic and diastolic blood 
pressure, and body temperature. 
17.2 Subject 
Cohorts and 
Subject 
Populations 
All efficacy and safety analyses will be done 
within the classified cohort. Durability of 
treatment effects defined as time period from 
injection to return to baseline cellulite severity 
ratings in a EN3835-treated quadrant will be 
determined for all subjects that were treated 
with EN3835 in either this study or study 
EN3835-201. 
All efficacy and safety analyses will be done 
within the classified cohort. Durability of 
treatment effects defined as the time from 
onset of change from baseline of PR-PCSS 
and CR-PCSS in the quadrant treated in study 
EN3835-201 until the time that the treated 
quadrant return to baseline cellulite severity 
ratings of PR-PCSS and CR-PCSS in an 
EN3835-treated quadrant will be determined 
for all subjects that were treated with EN3835 
in either this study or study EN3835-201. 
17.6.1 Prior, 
Concomitant, 
and Follow-up 
Medication 
The version used in this study will be stated in 
the Data Management Plan. Prior medication 
will be defined as any medication with a start 
date prior to the day 1 date and are collected at 
the screening visit and upon admission to the 
clinic on day í 
The version used in this study will be stated in 
the Data Management Plan. Prior medication 
will be defined as any medication with a start 
date prior to the Day 1 date. 
24.4 Use of 
Investigational 
Materials 
The Investigator is responsible for monitoring 
subject’s use of the study drug to ensure 
compliance with the protocol. All study 
supplies shall be returned to Endo 
Pharmaceuticals Inc. or its designee (this may 
include empty packaging such as bottles and 
blister cards). It is the Investigator’s 
responsibility to ensure that subjects return 
their medication. 
The Investigator is responsible for monitoring 
use of the study drug to ensure compliance 
with the protocol. All study supplies shall be 
returned to Endo Pharmaceuticals Inc. or its 
designee.  

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4 Synopsis, 
Number of 
subjects 
(planned) 
333 
Approximately 350 
4 Synopsis, 
Study center(s) 
16 sites in the United States 
15 sites in the United States 
4 Synopsis, 
Investigational 
product, dosage 
and mode of 
administration 
For the observational periods of this study, 
subjects will be assessed for safety and 
cellulite severity assessments at approximately 
3-month intervals for a maximum of 1 year 
following their first exposure to EN3835. 
For the observational periods of this study, 
subjects will be assessed for safety and 
cellulite severity assessments at approximately 
3-month intervals for a maximum of 1 year 
following their first exposure to EN3835 in 
each treated quadrant. 
4 Synopsis, 
Duration of study 
Twelve (12) months from first exposure to 
EN3835 in study EN3835-201 or study 
EN3835 202 
Twelve (12) months from first exposure to 
EN3835 in study EN3835-201 and 12 months 
from first exposure in any additional treated 
quadrants in the EN3835-202 study 
4 Synopsis, 
Observational 
Phase 
Subjects will be assessed at visits that occur 
approximately every 3 months for a maximum 
of 1 year after the first exposure to EN3835. 
Subjects will be assessed at visits that occur 
approximately every 3 months for a maximum 
of 1 year after the first exposure to EN3835 in 
each treated quadrant. 
4 Synopsis, 
Follow-up 
Subjects will be assessed at visits that occur 
approximately every 3 months for a maximum 
of 1 year after the first exposure to EN3835. 
For subjects treated with EN3835 in this 
study, subjects will be observed at treatment 
visits (Days 1, 22, and 43) and Day 71 after 
first injection. After Day 71, they will be 
observed every 3 months from their first 
exposure to EN3835 up to a maximum of 
1 year. 
Subjects will be assessed at visits that occur 
approximately every 3 months for a maximum 
of 1 year after the first exposure to EN3835 in 
each treated quadrant. For subjects treated 
with EN3835 in this study, subjects will be 
observed at treatment visits (Days 1, 22, and 
43) and Day 71 after first injection. After 
Day 71, they will be observed every 3 months 
from their first exposure to EN3835 up to a 
maximum of 1 year in each treated quadrant. 
4 Synopsis, 
Statistical 
methods, Sample 
Size 
Consideration 
The number of subjects (approximately 333) 
is intended to obtain additional subjects for 
adequate long-term safety data at the selected 
dose. 
Approximately 350 subjects are planned to 
obtain adequate long-term safety data for this 
study. 
4 Synopsis,  
Statistical 
methods, 
Analysis 
Populations 
Safety population: The Safety population is 
defined as all enrolled subjects who received 
at least 1 injection of EN3835 in this study or 
in study EN38335-201. 
Intent-to-Treat (ITT) population: The ITT 
population is defined as all enrolled subjects 
in this study. 
Safety population: The Safety population is 
defined as all enrolled subjects who received 
at least 1 injection of EN3835 in this study. 
Effectiveness population: This population is 
defined as all safety subjects who have a 
baseline and at least 1 post-injection 
evaluation of both the CR-PCSS and 
PR-PCSS.  

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Modified Intent-to-Treat (mITT) population: 
The mITT population is defined as ITT 
subjects who received at least 1 injection of 
EN3835 in this study with a baseline and 1 
post-injection evaluation of both the 
CR-PCSS and PR-PCSS. All efficacy 
(cellulite assessments) analyses will be 
completed on this population. 
Per-Protocol population: The Per-Protocol 
population is defined as those subjects in the 
Safety population who have no major protocol 
deviations.  
 
4 Synopsis,  
Statistical 
methods, 
Efficacy 
Evaluations 
The primary cellulite severity assessment 
endpoint, the proportion of composite 
responders with improvement of 2 or better on 
each scale (CR-PCSS and PR-PCSS) at 
Day 71, will be summarized as percentages 
and analyzed using a Cochran-Mantel-
Haenszel test that compares the 2 treatment 
groups and adjusts for Investigator. The ITT 
population will be evaluated for the primary 
endpoint with any subjects not having a post-
injection evaluation of either CR-PCSS or 
PR-PCSS classified as a non-responder. 
All secondary endpoints, except the Hexsel 
CSS total score, will be summarized as 
percentages. The dichotomous secondary 
endpoints (ie, responders endpoints) will be 
analyzed using a Cochran-Mantel-Haenszel 
test adjusted for investigator. Multiple-
response endpoints (ie, scales) will be 
analyzed using the Mann-Whitney test. 
Change in Hexsel CSS total score will be 
summarized with descriptive statistics for 
continuous variable and will be analyzed 
using analysis of variance (ANOVA). 
The composite endpoints for cellulite severity 
assessment, the proportions of composite 
responders with improvement of 2 (or 1) or 
better on each scale (CR-PCSS and 
PR-PCSS), will be summarized as numbers 
and percentages by study days (visit). The 
analysis will be based on Effectiveness 
population. 
All other endpoints including observational 
endpoints will be summarized by study days 
using appropriate descriptive statistics. The 
descriptive statistics will include the number 
and percentage for categorical response 
variables and number, mean, standard 
deviation, minimum, and maximum for 
continuous variables. 
5 Schedule of 
Events, Table 2, 
Procedures  
ADDED TEXT AND ROW 
Prior/Concomitant Medications/Procedure 
Screening A: X 
Visit 1: X 
Visit 2: X 
Visit 3: X 
Visit 4: X 
5 Schedule of 
Events, Table 2, 
footnotes 
bThree (3)-month evaluation periods begin 
90 days after Day 1 of the double-blind study 
(EN3835-201) (ie, within 20 days ±4 days of 
completion of double-blind study). 
b Four (4) visits at 3-month periods begin 
90 days after Day 1 of the double-blind 
study (EN3835-201) (ie, within 20 days ± 
4 days of completion of double-blind study). 
5 Schedule of 
Events, Table 3, 
Procedures 
Informed Consent 
Screening B: X 
DELETED TEXT AND ROW 

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9.2 Secondary 
Objectives 
To assess safety and immunogenicity of re-
treating or re-dosing a subject that had 
previously received treatment with EN3835 
x 
To evaluate safety and immunogenicity of 
re-treating or re-dosing a subject that had 
previously received treatment with 
EN3835 
10.1 Study 
Design 
The study is planned to end when at least 100 
subjects have 12 months after exposure ie 
12 months after first treatment in study 
EN3835 201 or study EN3835-202. 
DELETED TEXT 
10.1 Study 
Design 
Previously placebo-treated subjects will have 
the option to receive a second course of 
EN3835 in the same or different qualifying 
quadrant after at least 28 days following the 
end of the first treatment course (ie treatment 
of second quadrant could begin on Day 71 
after treating the first quadrant). The selected 
quadrant can be re-treated or re-dosed. 
Previously placebo-treated subjects will have 
the option to receive a second course of 
EN3835 in the same or different qualifying 
quadrant after at least 28 days following the 
end of the first treatment course (eg, the 
screening B visit of second quadrant could be 
performed on Day 71 after treating the first 
quadrant). The selected quadrant can be 
re-treated or re-dosed.  
10.1 Study 
Design, table 
N=333 
DELETED TEXT 
12.1.1 Subject 
Screening 
Upon completion of Day 71 assessments in 
the double-blind study EN3835-201, a subject 
will be eligible to enter this open-label 
extension study. Investigators will be expected 
to maintain a Screening Log of all potential 
study subjects. This log will include limited 
information about the potential subject and the 
date and outcome of the screening process (eg, 
enrolled into the study, reason for ineligibility, 
or refused to participate). Investigators will 
provide information about the study to 
subjects who appear to meet the criteria for 
participation in the study. 
Upon completion of Day 71 assessments in 
the double-blind study EN3835-201, a subject 
will be eligible to enter this open-label 
extension study. All potential subjects eligible 
for screening in EN3835-202 will be pre-
populated in the electronic data capture (EDC) 
system. The status of all subjects (eg, screen 
fails) will also be kept in the EDC system. 
12.1.3 Study 
Entry/Observatio
nal Assessments 
ADDED TEXT 
All subjects must complete Screening A and 
at least 1 Observation visit before Screening B 
can occur. Once the study blind was broken, 
the EN3835-201 placebo subjects were 
allowed to directly proceed to Screening B. 
12.1.4.5 Follow-
up Visits 
Follow-up visits will continue until the study 
is terminated when at least 100 subjects have 
been assessed at 12 months after the first 
exposure to EN3835. 
DELETED TEXT 

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12.5 End of 
Study 
The end of study is when 100 subjects 
complete the 1-year safety and cellulite 
severity evaluations. At the time of study 
termination, ongoing subjects receiving 
treatment will be followed through the Day 71 
visit. The remaining enrolled subjects (in 
excess of the first 100 subjects to complete 
1 year) will undergo early termination 
procedures in accord with the Schedule of 
Events (section 5). 
At the time of study termination, ongoing 
subjects receiving treatment will be followed 
through the Day 71 visit. The remaining 
enrolled subjects will undergo early 
termination procedures in accordance with the 
Schedule of Events (section 5). 
13.1.1.4 
Clinician-
Reported 
Photonumeric 
Cellulite Severity 
Scale (CR-PCSS) 
ADDED TEXT 
This variable may be entered directly into the 
EDC system, thus the electronic database will 
serve as the direct point of data capture and 
will serve as source for this variable.  
13.1.1.5 
Investigator 
Global Aesthetic 
Improvement 
Scale (I-GAIS) 
The Investigator will circle the rating below 
that best represents their answer. 
DELETED TEXT 
13.1.1.5 
Investigator 
Global Aesthetic 
Improvement 
Scale (I-GAIS) 
ADDED TEXT 
This variable may be entered directly into the 
EDC system, thus the electronic database will 
serve as the direct point of data capture and 
will serve as source for this variable. 
13.1.1.6 Hexsel 
Cellulite Severity 
Scale 
ADDED TEXT 
This variable may be entered directly into the 
EDC system, thus the electronic database will 
serve as the direct point of data capture and 
will serve as source for this variable. 
14.5.2 Reporting 
of Serious 
Adverse Events  
Any SAE that is felt by the Investigator to be 
related to the study medication must be 
reported regardless of the amount of time 
since the last dose received. 
Any SAE that is considered by the 
Investigator to be related to the study 
medication must be reported regardless of the 
amount of time since the last dose received. 
14.7 Clinical 
Laboratory  
ADDED TEXT 
Results of the urine pregnancy test may be 
entered directly into the EDC system, thus the 
electronic database will serve as the direct 
point of data capture and will serve as source 
for this variable. 
14.7.1 Anti-
AUX-I and Anti-
AUX-II 
Antibodies 
Serum samples will be collected and may be 
tested for binding and neutralizing anti-AUX-I 
and anti-AUX-II antibodies at visit 1 and 
visit 4. 
Serum samples will be collected and may be 
tested for binding and neutralizing anti-AUX-I 
and anti-AUX-II antibodies at Visit 4 of the 
observation assessments. 

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14.8 Vital Signs 
ADDED TEXT 
The subject’s vital signs should be stable, or 
repeated until stable before the subject can 
leave direct observation. 
This variable may be entered directly into the 
EDC system, thus the electronic database will 
serve as the direct point of data capture and 
will serve as source for this variable.  
14.9 Electro- 
cardiogram 
ADDED TEXT 
The investigator’s assessment may be entered 
directly into the EDC system, thus the 
electronic database will serve as the direct 
point of data capture and will serve as source 
for this variable.  
14.10 Physical 
Examination 
ADDED TEXT 
This variable may be entered directly into the 
EDC system, thus the electronic database will 
serve as the direct point of data capture and 
will serve as source for this variable. 
17.1 
Determination of 
Sample Size 
It is estimated that approximately 95% of the 
350 subjects randomized in study 
EN3835-201 will enroll in the current study 
for a sample size of 333. This sample size 
should be adequate to determine safety and 
cellulite assessments of EN3835 for subjects 
retreated in the same and in different 
quadrants. 
Approximately 350 subjects that completed 
the EN3835-201study will enroll in the 
current study. This sample size should be 
adequate to determine long term safety and 
cellulite assessments of EN3835. 
17.2 Subject 
Cohorts and 
Subject 
Populations 
Durability of treatment effects defined as the 
time from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant 
treated in study EN3835-201 until the time 
that the treated quadrant return to baseline 
cellulite severity ratings of PR-PCSS and 
CR-PCSS in an EN3835-treated quadrant will 
be determined for all subjects that were 
treated with EN3835 in either this study or 
study EN3835-201. 
Durability of treatment effects is defined as 
the time from onset of change from baseline 
of PR-PCSS and CR-PCSS in the quadrant 
treated until the time that the treated quadrant 
returns to baseline cellulite severity ratings of 
PR-PCSS and CR-PCSS in an EN3835-treated 
quadrant. 
17.2.2 Safety 
Population 
The Safety population will include all subjects 
who receive at least 1 dose of EN3835 in the 
current study or in study EN3835-201. All 
safety analyses will be performed using this 
population. 
The Safety population will include all subjects 
who receive at least 1 dose of EN3835 in the 
current study. All safety analyses will be 
performed using this population. 
17.2.3 
Effectiveness 
Population 
Intent-to-Treat Population 
The Intent-to-Treat (ITT) population includes 
all subjects who enroll in the current study. 
Effectiveness Population 
The Effectiveness population includes all 
safety subjects who have a baseline and at 
least 1 post-baseline assessment on both the 
CR-PCSS and PR-PCSS on the quadrant 
selected for treatment in the current study. All 
analysis of effectiveness will be based on this 
population. 

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17.2.4 Modified 
Intent-to-Treat 
Population 
17.2.4 Modified Intent-to-Treat Population 
The Modified Intent-to-Treat (mITT) 
population includes all subjects who receive at 
least 1 dose of EN3835 in the current study 
(EN3835-202) and have a baseline and at least 
1 post-baseline assessment on both the 
CR-PCSS and PR-PCSS on the quadrant 
selected for treatment in the current study. All 
cellulite assessment analyses will be 
completed on this population. 
DELETED TEXT 
17.2.5 Per-
Protocol 
Population 
17.2.5 Per-Protocol Population  
The Per-Protocol population includes all 
subjects in the safety population who have no 
major protocol deviations. Major protocol 
deviations excluding subjects from this 
population will be determined at the protocol 
deviation assessment meeting prior to the 
database lock. If more than 10% of the safety 
population is excluded from the per-protocol 
population, then all safety and cellulite 
evaluations will be repeated using the per-
protocol population. 
DELETED TEXT 
17.4 
Demographics 
and Other 
Baseline 
Characteristics 
Demographic and baseline characteristics, 
including age, race, and baseline values will 
be summarized for the Observational 
population, the Safety population, and the 
mITT population using descriptive statistics. 
The descriptive statistics will include 
frequency tables for all categorical response 
variables and number, mean, standard 
deviation, minimum, and maximum for all 
continuous variables.  
Demographic and baseline characteristics, 
including age, race, and baseline values will 
be summarized for the Observational 
population, the Safety population, and the 
Effectiveness population using descriptive 
statistics. The descriptive statistics will 
include the number and percentage for 
categorical response variables and number, 
mean, standard deviation, minimum, and 
maximum for continuous variables.  
17.5.1 Efficacy 
Analysis 
The primary cellulite severity endpoint is the 
proportion of composite responders at Day 71 
defined as subjects with an improvement in 
severity from baseline (Screening B visit) of 
at least 2 levels of severity in the CR-PCSS 
and an improvement in severity from baseline 
of at least 2 levels of severity in the PR-PCSS. 
The primary endpoint, the proportion of 
composite responders with improvement of 2 
or better on each scale (CR-PCSS and 
PR-PCSS) will be summarized by region 
treated (buttock or thigh) and overall with 
percentages. 
The composite endpoints for cellulite severity 
are the proportions of composite responders 
defined as subjects with an improvement in 
severity from baseline of at least 2 (or 1) 
levels of severity in the CR-PCSS and an 
improvement in severity from baseline of at 
least 2 (or 1) levels of severity in the 
PR-PCSS. 
These endpoints, will be summarized by 
treated quadrant and overall (buttocks and 
thighs) and by study day using appropriate 
descriptive statistics. 
17.5.1 Efficacy 
Analysis 
Secondary Efficacy Analysis 
Other endpoints for treated quadrants include: 

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17.5.1 Efficacy 
Analysis 
Proportion of composite responders defined as 
subjects with an improvement in severity from 
baseline of at least 1 level of severity in the 
CR-PCSS and an improvement of severity 
from baseline of at least 1 level of severity in 
the PR-PCSS. (Day 71) 
Proportion at each level of improvement in the 
PR-PCSS (Day 71): 
Proportion of patient responders defined as 
subjects with an improvement in severity from 
baseline of at least 2 levels of severity in the 
PR-PCSS 
Proportion of patient responders defined as 
subjects with an improvement in severity from 
baseline of at least 1 level of severity in the 
PR-PCSS 
Proportion at each level of improvement in the 
CR-PCSS (Day 71): 
Proportion of Investigator responders defined 
as subjects with an improvement in severity 
from baseline of at least 2 levels of severity in 
the CR-PCSS (Investigator rated) 
Proportion of Investigator responders defined 
as subjects with an improvement in severity 
from baseline of at least 1 level of severity in 
the CR-PCSS (Investigator rated) 
Proportion of responders at each level of the 
I-GAIS (Day 71): 
Proportion of Investigator global responders 
defined as subjects with a response of 1 
(improved) or better in the Investigator GAIS 
assessment  
Proportion of responders at each level of the 
S-GAIS (Day 71): 
Proportion of subject global responders 
defined as subjects with a response of 
1 (improved) or better in the subject GAIS 
assessment 
Proportion of responders at each level of the 
subject satisfaction with cellulite treatment 
(Day 71) 
Change in the Hexsel CSS total score from 
screening visit to Day 71 
All secondary endpoints, except the Hexsel 
CSS total score, will be summarized by 
treated region (buttock or thigh) and overall 
using percentages. Change in Hexsel CSS 
total score will be summarized by treated 
region (buttock or thigh) and overall with 
descriptive statistics for continuous variables. 
x 
Proportion at each level of improvement 
in the PR-PCSS: 
í 
Proportion of patient responders 
defined as subjects with an 
improvement in severity from 
baseline of at least 2 levels of 
severity in the PR-PCSS 
í 
Proportion of patient responders 
defined as subjects with an 
improvement in severity from 
baseline of at least 1 level of severity 
in the PR-PCSS 
x 
Proportion at each level of improvement 
in the CR-PCSS: 
í 
Proportion of Investigator responders 
defined as subjects with an 
improvement in severity from 
baseline of at least 2 levels of 
severity in the CR-PCSS 
(Investigator rated) 
í 
Proportion of Investigator responders 
defined as subjects with an 
improvement in severity from 
baseline of at least 1 level of severity 
in the CR-PCSS (Investigator rated) 
x 
Proportion of responders at each level of 
the I-GAIS: 
í 
Proportion of Investigator global 
responders defined as subjects with a 
response of 1 (improved) or better in 
the Investigator GAIS assessment 
x 
Proportion of responders at each level of 
the S-GAIS: 
í 
Proportion of subject global 
responders defined as subjects with a 
response of 1 (improved) or better in 
the subject GAIS assessment  
x 
Proportion of responders at each level of 
the subject satisfaction with cellulite 
treatment  
x 
Change in the Hexsel CSS total score 
from screening visit  
All endpoints will be summarized by treated 
region (buttock or thigh) and overall and by 
study day using appropriate descriptive 
statistics. 

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Observational endpoints include: 
Proportion of 2-point composite responders as 
defined by responses in the quadrant treated in 
study EN3835-201 who either maintained 
response, lost response but did not return to 
the baseline of study EN3835-201, or returned 
to the baseline of study EN3835-201. 
Proportion of 1-point composite responders as 
defined by responses in the quadrant treated in 
study EN3835-201 who either maintained 
response, lost response but did not return to 
the baseline of study EN3835-201, or returned 
to the baseline of study EN3835-201. 
Proportion of 2-point CR-PCSS responders as 
defined by responses in the quadrant treated in 
study EN3835-201 who either maintained 
response, lost response but did not return to 
the baseline of study EN3835-201, or returned 
to the baseline of study EN3835-201.  
Proportion of 1-point CR-PCSS responders as 
defined by responses in the quadrant treated in 
study EN3835-201 who either maintained 
response, lost response but did not return to 
the baseline of study EN3835-201, or returned 
to the baseline of study EN3835-201. 
Proportion of 2-point PR-PCSS responders as 
defined by responses in the quadrant treated in 
study EN3835-201 who either maintained 
response, lost response but did not return to 
the baseline of study EN3835-201, or returned 
to the baseline of study EN3835-201. 
Proportion of 1-point PR-PCSS responders as 
defined by responses in the quadrant treated in 
study EN3835-201 who either maintained 
response, lost response but did not return to 
the baseline of study EN3835-201, or returned 
to the baseline of study EN3835-201. 
Duration of response as defined by the time 
from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant 
treated in study EN3835-201 until the time 
that the treated quadrant returned to the 
baseline PR-PCSS and CR-PCSS ratings from 
study EN3835-201. 
CR-PCSS change from the study EN3835-201 
baseline at Day 71 of study EN3835-201, and 
Days 90, 180, 270, and 360/end of study of 
the current study (EN3835-202). 
Observational endpoints include: 
x 
Proportions of composite responders 
defined as subjects with an improvement 
in severity from baseline of at least 2 
(or 1) levels of severity in the CR-PCSS 
and an improvement in severity from 
baseline of at least 2 (or 1) levels of 
severity in the PR-PCSS. 
x 
Proportion at each level of improvement 
in the PR-PCSS: 
í 
Proportion of patient responders 
defined as subjects with an 
improvement in severity from 
baseline of at least 2 levels of 
severity in the PR-PCSS 
í 
Proportion of patient responders 
defined as subjects with an 
improvement in severity from 
baseline of at least 1 level of severity 
in the PR-PCSS 
x 
Proportion at each level of improvement 
in the CR-PCSS: 
í 
Proportion of Investigator responders 
defined as subjects with an 
improvement in severity from 
baseline of at least 2 levels of 
severity in the CR-PCSS 
(Investigator rated) 
í 
Proportion of Investigator responders 
defined as subjects with an 
improvement in severity from 
baseline of at least 1 level of severity 
in the CR-PCSS (Investigator rated) 
x 
Hexsel CSS total score changed from the 
study EN3835-201 baseline at Day 71 of 
study EN3835-201 and Day 360/end of 
study of the current study (EN3835-202).  
These endpoints will be summarized by 
treated region (buttock or thigh) and overall 
and by study day using appropriate descriptive 
statistics. 

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PR-PCSS change from the study EN3835-201 
baseline at Day 71 of study EN3835-201, and 
Days 90, 180, 270, and 360/end of study of 
the current study (EN3835-202). 
Hexsel CSS total score changed from the 
study EN3835-201 baseline at Day 71 of 
study EN3835-201 and Day 360/end of study 
of the current study (EN3835-202).  
Proportion of responses at each level of the 
I-GAIS (Day 360/end of study): 
Proportion of Investigator global responders 
defined as subjects with a response of 1 
(improved) or better in the Investigator GAIS 
assessment 
Change in I-GAIS assessment from Day 71 of 
study EN3835-201 and Day 360/ end of study 
of the current study (EN3835-202 
Proportion of responses at each level of the 
S-GAIS (Day 360/end of study): 
Proportion of subject global responders 
defined as subjects with a response of 
1 (improved) or better in the subject GAIS 
assessment 
Proportion of 2-point PR-PCSS responders as 
defined by the responses in the quadrant 
treated in the current study who either 
maintained response, lost response but did not 
return to the study EN3835-202 baseline, or 
returned to the study EN3835-202 baseline. 
Proportion of 1-point PR-PCSS responders as 
defined by the responses in the quadrant 
treated in the current study who either 
maintained response, lost response but did not 
return to the study EN3835-202 baseline, or 
returned to the study EN3835-202 baseline. 
Change in S-GAIS assessment from Day 71 of 
study EN3835-201 and Day 360/ end of study 
of the current study (EN3835-202) 
Proportion of responses at each level of the 
subject satisfaction with cellulite treatment 
(Day 360/end of study) 
Change in subject satisfaction assessment 
from Day 71 of study EN3835-201 and 
Day 360/end of study of the current study 
(EN3835-202) 
 

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For quadrants treated in the current study the 
following observational endpoints will be 
analyzed: 
Proportion of 2-point composite responders as 
defined by the responses in the quadrant 
treated in this current study (EN3835-202) 
who either maintained response, lost response 
but did not return to the study EN3835-202 
baseline, or returned to the study EN3835-202 
baseline. 
Proportion of 1-point composite responders as 
defined by the responses in the quadrant 
treated in the current study who either 
maintained response, lost response but did not 
return to the study EN3835-202 baseline, or 
returned to the study EN3835-202 baseline. 
Proportion of 2-point CR-PCSS responders as 
defined by the responses in the quadrant 
treated in this current study who either 
maintained response, lost response but did not 
return to the study EN3835-202 baseline, or 
returned to the study EN3835-202 baseline. 
Proportion of 1-point CR-PCSS responders as 
defined by the responses in the quadrant 
treated in the current study who either 
maintained response, lost response but did not 
return to the study EN3835-202 baseline, or 
returned to the study EN3835-202 baseline. 
CR-PCSS change from the study EN3835-202 
baseline at Day 71, Day 90, Day 180, 
Day 270, and Day 360/end of study. 
PR-PCSS change from the study EN3835-202 
baseline at Day 71, Day 90, Day 180, 
Day 270, and Day 360/end of study. 
Duration of response as defined by the time 
from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant 
treated in the current study until the time that 
the treated quadrant returned to the baseline 
PR-PCSS and CR-PCSS ratings from study 
EN3835-202. 
 
17.6.3 
Measurement of 
Treatment 
Compliance 
All doses are administered while the subjects 
are at the investigators’ sites. 
All doses are administered while the subjects 
are at the investigational site. 

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17.6.4 Adverse 
Events 
The MedDRA will be used to code AEs. The 
version used in this study will be stated in the 
Data Management Plan. 
An AE (classified by preferred term) that 
started during the treatment period will be 
considered a TEAE if it was not present prior 
to the first dose of study drug, or was present 
prior to the first dose of study drug but 
increased in intensity during the treatment 
period. If more than 1 AE is reported prior to 
the first dose of study drug and coded to the 
same preferred term, then the AE with the 
greatest intensity will be used as the 
benchmark for comparison to the AEs 
occurring during the treatment period which 
were also coded to that preferred term. Any 
AE present prior to the first dose of study drug 
that increases in intensity during the treatment 
period will be re-entered with a new start date 
of the date of increased intensity.  
Descriptive statistics (the number and 
percentage) for subjects reporting TEAEs in 
each treatment group will be tabulated by 
system organ class and preferred term; by 
system organ class, preferred term, and 
severity; and by system organ class, preferred 
term, and relationship to study drug. If more 
than 1 AE is coded to the same preferred term 
for the same subject, the subject will be 
counted only once for that preferred term 
using the most severe and most related 
occurrence for the summarization by severity 
and by relationship to the study drug. 
SAEs and AEs leading to premature 
discontinuation of study drug will be 
summarized by preferred term and dose 
received. Listings will be presented for 
subjects with SAEs, subjects with AEs leading 
to discontinuation, and subjects who die (if 
any). 
The MedDRA dictionary will be used to code 
AEs. The version used in this study will be 
stated in the Data Management Plan. 
Descriptive statistics (the number and 
percentage) for subjects reporting TEAEs will 
be tabulated by system organ class and 
preferred term; by system organ class, 
preferred term, and severity; and by system 
organ class, preferred term, and relationship to 
study drug. If more than 1 AE is coded to the 
same preferred term for the same subject, the 
subject will be counted only once for that 
preferred term using the most severe and most 
related occurrence for the summarization by 
severity and by relationship to the study drug. 
SAEs and AEs leading to premature 
discontinuation of study drug will be 
summarized. Listings will be presented for 
subjects with SAEs, subjects with AEs leading 
to discontinuation, and subjects who die (if 
any). 
17.6.5 Vital 
Signs 
Descriptive statistics for vital signs (eg, 
systolic and diastolic blood pressure, pulse 
rate, and body weight) and their changes from 
baseline at each visit and at the end of 
treatment visit will be presented. 
Descriptive statistics for vital signs (eg, 
systolic and diastolic blood pressure, pulse 
rate, respiratory rate, temperature, and body 
weight) and their changes from baseline at 
each visit and at the end of treatment visit will 
be presented.  
17.7 
Immunogenicity 
Analyses 
Binding antibody levels will be determined 
from samples collected on Days 1, 22, 43, and 
71 during the treatment phase and Days 90, 
180, 270 and 360 during the observational 
phase. 
Binding antibody levels will be determined 
from samples collected on Days 1 and 71 
during the treatment phase and Day 360 
during the observational phase. 

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17.9 Interim 
Analysis 
Two (2) interim analyses are planned. 
Following the breaking of the study drug blind 
in study EN3835-201, all follow-up safety 
data gathered prior to that time will be 
analyzed. The second interim analyses will 
occur following the Day 71 visit for all 
subjects treated with EN3835 in the current 
study. A preliminary data lock will be done on 
all treated quadrants and cellulite assessment 
and safety analyses will be done. The official 
database lock will occur after the last 
Day 360/end of study observational visit and 
all observational analyses on treated quadrants 
will be done. 
Not applicable. 
18.4 Study Drug 
Preparation 
Refer to the Reconstitution Instructions in the 
Pharmacy Manual for detailed preparation 
instructions. 
Refer to the Reconstitution Instructions for 
detailed preparation instructions. 
18.4 Study Drug 
Preparation 
Each vial of study drug powder for 
reconstitution will be diluted according to the 
instructions in the Pharmacy Manual. 
Each vial of study drug powder for 
reconstitution will be diluted according to the 
Reconstitution Instructions. 
19.1 Source 
Documents 
Source documents include but are not limited 
to original documents, data and records such 
as hospital/ medical records (including 
electronic health records), clinic charts, lab 
results, subject diaries, data recorded in 
automated instruments, microfilm or magnetic 
media, and pharmacy records, etc. At a 
minimum, all data required to be collected by 
the protocol should have supporting source 
documentation for entries in the eCRF, unless 
the protocol specifies that data can be 
recorded directly on/in the eCRF or other 
device. 
This study allows for direct data entry (DDE) 
for selected data points as outlined below: 
x 
Inclusion/Exclusion 
x 
Vital signs including pre- and post-
injection measurements 
x 
Height and body weight 
x 
CR-PCSS 
x 
Hexsel CSS 
x 
I-GAIS 
x 
Physical examinations 
x 
ECG results (if more than 1 year passed 
since ECG assessment) 
x 
Urine pregnancy test 
x 
Study drug administration  
All other data points, at a minimum, should 
have supporting source documentation for 
entries in the eCRF. 
22.1 Data 
Collection 
Study data will be collected from source 
documents and entered into an eCRF within 
the EDC system. 
Study data will be collected by DDE or from 
source documents and entered into an eCRF 
within the EDC system. 
22.1 Data 
Collection 
Unless otherwise indicated, all data captured 
in the eCRF must first be captured in source 
documents. Data that can be directly recorded 
in the eCRF will be clearly identified in the 
section(s) of the protocol that describes the 
assessment(s). 
DELETED TEXT 

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22.2 Study 
Documentation 
Upon study completion, the Investigator will 
be provided with complete electronic copies 
of the CRF data for his/her files.  
Upon study completion, the Investigator will 
be provided with complete electronic copies 
of the eCRF data for his/her files.  
 

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4. 
SYNOPSIS 
Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Title of Study: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous 
Fibrosclerotic Panniculopathy 
Lead Principal Investigator: To be determined 
Study period:  
Estimated date first subject enrolled: Oct-2016 
Estimated date last subject completed: Jun-2018 
Phase of development: Phase 2 
Objectives:  
Primary: 
x 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at 
scheduled intervals over 1 year (12 months) in all subjects with edematous fibrosclerotic 
panniculopathy (EFP) who elect to enroll in this open-label trial regardless of their decision to 
receive treatment (re-treatment or re-dosing) of open-label EN3835 or opt to receive no 
treatment.  
Secondary: 
x 
To evaluate safety and immunogenicity of re-treating or re-dosing a subject that had previously 
received treatment with EN3835 
x 
To evaluate the durability of response to EN3835 in EFP severity over the 12-month post initial 
dosing of EN3835 in subjects previously receiving active treatment in study EN3835-201 using 
the Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and the Clinician-
Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 
x 
To evaluate long-term response to EN3835 in assessments of EFP including subject satisfaction, 
Investigator Global Aesthetic Improvement Scale (I-GAIS), and Subject Global Aesthetic 
Improvement Scale (S-GAIS) 
x 
To assess cellulite severity assessments in quadrants treated in this study with EN3835 
x 
To evaluate immunogenicity after exposure to EN3835 
Study Design: This study is a Phase 2 open-label study for the safety and efficacy of EN3835 in the 
treatment of EFP. To be eligible, a subject must have participated and completed the previous cellulite 
study EN3835-201. Subjects will be screened for study eligibility within 14 days prior to enrolling in 
this study (EN3835-202). Subjects will be assessed for safety and cellulite severity assessments 
approximately every 3 months for a maximum of 1 year from their first exposure to EN3835 in each 
treated quadrant. Subjects with at least 1 quadrant with moderate or severe level of cellulite will be 
eligible for treatment with EN3835 after unblinding of study EN3835-201; a quadrant that was treated 
with EN3835 in the previous study EN3835-201 will only be eligible for retreatment if the cellulite 
severity in that quadrant is rated at levels of cellulite severity at baseline or greater in study 
EN3835-201. 
A treatment course will consist of 3 treatment sessions separated by 21 days. Treatment will be allowed 
in eligible subjects up to a maximum of 2 treatment courses including the treatment course in study 
EN3835-201 if subject was treated with EN3835. Each treatment session will consist of up to 
12 injections (0.07 mg/0.3 mL per injection) of EN3835 for a dose of 0.84 mg and volume of 3.6 mL. 

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Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Only a quadrant with moderate (rating of 3) or severe (rating 4) level of severity as assessed by the 
subject and investigator using the PR-PCSS and the CR-PCSS, respectively, will be eligible for 
treatment; if more than 1 eligible quadrant exists, the quadrant selected will be at the discretion of the 
subject. Treatments will be administered on Days 1, 22, and 43; subjects will be assessed for safety on 
Days 1, 22, 43, and 71 and for cellulite severity assessments at Screening visit and on Days 22, 43, and 
71. After Day 71, they will be observed every 3 months from their first exposure to EN3835 up to a 
maximum of 1 year in each treated quadrant.  
Number of subjects (planned): Approximately 350 
Study center(s): 15 sites in the United States  
Diagnosis and inclusion/exclusion criteria: 
Qualification for the Open-Label Observation Phase of the Study 
Inclusion criteria for observation:  
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be willing to apply sunscreen to any treated quadrant before each exposure to the sun while 
participating in the study (ie, screening through end of study) 
Exclusion criteria for observation: 
None 
Qualification for the Open-Label Treatment Phase of the Study 
Inclusion criteria for treatment: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. %HDIHPDOH\HDUVRIDJH 
4. At Screening B visit, have at least 1 quadrant with: 
a. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 
b. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and 
c. a Hexsel Cellulite Severity Scale (CSS) score no greater than 13 
5. Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun 
while participating in the study (ie, Screening B through end of study) 
6. Be judged to be in good health, based upon the results of a medical history, physical 
examination, and laboratory profile at Screening B 
7. Have a negative urine pregnancy test at Screening B and before injection of study drug and be 
using an effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal 
[estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle 
prior to study enrollment and for the duration of the study; or be menopausal defined as 
12 months of amenorrhea in the absence of other biological or physiological causes, as 
determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile 
8. Be willing and able to cooperate with the requirements of the study 
9. Be able to read, complete and understand the patient-reported outcomes rating instruments in 
English 

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Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Exclusion criteria for treatment: 
1. Has used any of the following for the treatment of EFP on the legs or buttock within the 
timelines identified below or intends to use any of the following at any time during the course of 
the study: 
x 
Liposuction on the side of the body selected for treatment during the 12-month period 
before injection of study drug 
x 
Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery 
(including subcision and/or powered subcision) within the selected treatment quadrant 
during the 12-month period before injection of study drug 
x 
Endermologie or similar treatments within the selected treatment quadrant during the 
6-month period before injection of study drug 
x 
Massage therapy within the selected treatment quadrant during the 3-month period before 
injection of study drug 
x 
Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected 
treatment quadrant during the 2-week period before injection of study drug 
2. Is presently nursing a baby or providing breast milk for a baby 
3. Intends to become pregnant during the study 
4. Has received an investigational drug or treatment within 30 days before injection of study drug 
5. Has a known systemic allergy to collagenase or any other excipient of study drug 
6. Is currently receiving or plans to receive anticoagulant or antiplatelet medication or has received 
DQWLFRDJXODQWRUDQWLSODWHOHWPHGLFDWLRQH[FHSWIRUPJDVSLULQGDily) within 7 days before 
injection of study drug 
7. Has a known recent history of stroke, bleeding, or other medical condition, which in the 
investigator’s opinion would make the subject unsuitable for enrollment in this phase of the 
study 
8. Presence of any clinically relevant conditions, that in the opinion of the Investigator would 
interfere with completing the study including, but not limited to, visual problems, hearing 
problems, cognitive impairment or acute mental illness 
Investigational product, dosage and mode of administration: EN3835, 0.84 mg, subcutaneous. A 
dose of 0.84 mg of EN3835 will be administered as up to 12 subcutaneous injections (0.3-mL injection 
administered as three 0.1-mL aliquots per injection, up to 12 injections per treatment session) for a 
maximum volume of 3.6 mL per treatment session. A treatment course will consist of 3 treatment 
sessions at 21 days intervals, ie, treatments on Days 1, 22, and 43 of each treatment course. 
For the observational periods of this study, subjects will be assessed for safety and cellulite severity 
assessments at approximately 3-month intervals for a maximum of 1 year following their first exposure 
to EN3835 in each treated quadrant. 
Duration of study:  
Twelve (12) months from first exposure to EN3835 in study EN3835-201 and 12 months from first 
exposure in any additional treated quadrants in the EN3835-202 study 
Screening Phase: Up to 14 days 
Observational Phase: Subjects will be assessed at visits that occur approximately every 3 months for a 
maximum of 1 year after the first exposure to EN3835 in each treated quadrant. 

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Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Follow-up: Subjects will be assessed at visits that occur approximately every 3 months for a maximum 
of 1 year after the first exposure to EN3835 in each treated quadrant. For subjects treated with EN3835 
in this study, subjects will be observed at treatment visits (Days 1, 22, and 43) and Day 71 after first 
injection. After Day 71, they will be observed every 3 months from their first exposure to EN3835 up to 
a maximum of 1 year in each treated quadrant. 
Reference therapy, dosage and mode of administration: Not applicable 
Criteria for evaluation: 
Efficacy: 
x 
PR-PCSS while viewing digital images of the selected quadrant: 5-point scale ranging from 
0 (no cellulite) to 4 (severe cellulite) (approximately every 3 months after initial injection [either 
an injection in previous study EN3835-201 or after an injection in this study]). If treatment is 
administered in this study, PR-PCSS will be obtained at Screening B (Baseline), Days 22, 43, 
and 71 after initial treatment within this study. 
x 
Investigator using the CR-PCSS by live assessment: 5-point scale ranging from 0 (no cellulite) 
to 4 (severe cellulite) (every 3 months after initial injection [either an injection in previous study 
EN3835-201 or after an injection in this study]). If treatment is administered in this study, 
CR-PCSS will be obtained at Screening B (Baseline), Days 22, 43, and 71 after initial treatment 
within this study. 
x 
Investigator rating of cellulite severity using the total score from the Hexsel CSS: scores can 
range from 0 (no cellulite) to 15 (extremely severe cellulite) (Day 360). If treatment is 
administered in this study, Hexsel CSS will be obtained in this study at Screening B (Baseline) 
and Day 71 after initial treatment within this study. 
x 
I-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) (Day 71) 
x 
S-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) (Day 71) 
x 
Subject satisfaction with cellulite treatment assessment: 5-point scale ranging from 2 (very 
satisfied) to í2 (very dissatisfied) (Day 71) 
Safety:  
Safety will be assessed throughout the study through the recording of: 
x 
Adverse events (AEs) 
x 
Vital signs 
x 
Clinical laboratory tests 
x 
Immunogenicity assessment (ie, assessed through the determination of binding and neutralizing 
anti-AUX-I and anti-AUX-II antibody levels) 
In addition, for subjects treated with EN3835 in this study, injection site reactions/local tolerability in 
treated quadrant (through subject and Investigator reporting) will be assessed. 
Statistical methods: 
Sample Size Consideration:  
Approximately 350 subjects are planned to obtain adequate long-term safety data for this study. 
Analysis Populations:  
Observational population: The Observational population is defined as all subjects treated with EN3835 
in study EN3835-201 who do not receive any treatment in the current study. 

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Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Safety population: The Safety population is defined as all enrolled subjects who received at least 
1 injection of EN3835 in this study. 
Effectiveness population: This population is defined as all safety subjects who have a baseline and at 
least 1 post-injection evaluation of both the CR-PCSS and PR-PCSS.  
Efficacy Evaluations: 
The composite endpoints for cellulite severity assessment, the proportions of composite responders with 
improvement of 2 (or 1) or better on each scale (CR-PCSS and PR-PCSS), will be summarized as 
numbers and percentages by study days (visit). The analysis will be based on Effectiveness population . 
All other endpoints including observational endpoints will be summarized by study days using 
appropriate descriptive statistics. The descriptive statistics will include the number and percentage for 
categorical response variables and number, mean, standard deviation, minimum, and maximum for 
continuous variables.  
Safety Analysis:  
The following variables are safety endpoints: 
x 
AEs: Mapped to preferred term using the Medical Dictionary for Regulatory Activities 
(MedDRA) 
x 
Vital signs 
x 
Clinical laboratory tests 
AEs will be summarized by proportion of subjects reporting each event. Descriptive statistics will be 
presented for actual and change from baseline at each visit for vital signs and for each clinical laboratory 
test parameter. 
Immunogenicity: Anti-AUX-I and anti-AUX-II antibody levels will be summarized using descriptive 
statistics for the actual value at the visit. 
 

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5. 
SCHEDULE OF EVENTS 
NOTE: Observation visits (Table 2) in the open-label extension study begin after completion of 
double-blind study (Day 71). Treatment sessions (Table 3), if elected, will begin after study drug 
blind is broken in study EN3835-201while observation visits continue concurrently. 
 

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a After the study drug blind is broken in study EN3835-201, eligible subjects may elect to receive EN3835 treatments. 
b Upon completion of treatment, subject will be followed at 3-month intervals as in Table 2; if study terminates early, subject will be followed through Visit 4 
(Day 71). If subject received placebo in the double-blind study (EN3835-201), she may be eligible for a total of 2 courses of treatment (a total of 6 treatment 
sessions) in this study. 
c All 4 quadrants are photographed at screening; at other visits, the selected quadrant only is photographed. 
d Before and after marking the dimples. 
e Before injection. 
f Up to 4 hours before injection; approximately 15 and 30 minutes after injection. Vital signs must be stable before the subject is discharged. 
g Assessment made via photograph (if treatment session, use photograph taken before marking dimples). 
h All 4 quadrants are assessed at the Screening B visit; at other visits, the selected quadrant only is assessed. 
i Initial Hexsel CSS at sFUHHQLQJPXVWEHRQselected quadrant (Appendix C). 
j To qualify for treatment, the selected quadrant must have a score of 3 or 4 (moderate or severe) in both the CR-PCSS and PR-PCSS, and a Hexsel CSS score 
; to qualify a quadrant that had been previously treated with EN3835 in study EN3835-201, the quadrant must have CR-PCSS and PR-PCSS scores equal to 
or greater than study EN3835-EDVHOLQHVFRUHVDQGD+H[VHO&66VFRUH13. 
k Medical history and prior medications will be based on EN3835-201 eCRF; only updates and concomitant medications need to be captured at Screening B visit. 
l Do not conduct if Screening B visit date is within 12 months of obtaining an ECG during the double-blind study (EN3835-201). 
m Do not conduct on subjects eligible and opting-in for a second course of treatment in the current study (EN3835-202) if Screening B visit or Day 1 visit for 
second treatment course is the same day as Day 71 of the first treatment course in this study or previous study EN3835-201. 
ECG=Electrocardiogram; eCRF=Electronic case report form; EFP=Edematous fibrosclerotic panniculopathy; Tx=Treatment 
NOTE: Subject cellulite assessments must be completed before the Investigator cellulite assessments are conducted at each visit. 
 

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6. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES 
TABLE OF CONTENTS 
1. 
TITLE PAGE ................................................................................................................1 
2. 
SUMMARY OF CHANGES ........................................................................................2 
3. 
SPONSOR CONTACT INFORMATION .................................................................23 
4. 
SYNOPSIS .................................................................................................................24 
5. 
SCHEDULE OF EVENTS .........................................................................................29 
6. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ...............33 
7. 
LIST OF ABBREVIATIONS.....................................................................................39 
8. 
INTRODUCTION ......................................................................................................41 
8.1. 
Edematous Fibrosclerotic Panniculopathy .................................................................41 
8.2. 
Current Edematous Fibrosclerotic Panniculopathy Treatments .................................41 
8.3. 
EN3835 (Collagenase Clostridium Histolyticum) ......................................................43 
8.3.1. 
Studies with EN3835 for the Treatment of Edematous Fibrosclerotic 
Panniculopathy ...........................................................................................................43 
8.3.1.1. 
Investigator-Initiated Proof-of-Concept Study ...........................................................43 
8.3.1.2. 
Endo-Sponsored Phase 1b Dose-Escalation Study AUX-CC-830 .............................44 
8.3.1.3. 
Endo-Sponsored Phase 2a Dose-Ranging Study AUX-CC-831 ................................44 
8.3.1.4. 
Endo-Sponsored Phase 2b Study EN3835-201 ..........................................................44 
8.4. 
Summary of Nonclinical Studies ................................................................................45 
8.5. 
Summary of Known Risks and Benefits .....................................................................45 
8.6. 
Rationale .....................................................................................................................45 
9. 
OBJECTIVES .............................................................................................................46 
9.1. 
Primary Objective .......................................................................................................46 
9.2. 
Secondary Objectives .................................................................................................46 
9.3. 
Exploratory Objectives ...............................................................................................46 
10. 
INVESTIGATIONAL PLAN .....................................................................................47 
10.1. 
Study Design ...............................................................................................................47 
10.2. 
Selection of Doses ......................................................................................................49 
10.3. 
Study Drug Administration.........................................................................................49 
10.4. 
Discussion of Study Design, Including the Choice of Control Groups ......................49 

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11. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................50 
11.1. 
Observation Phase ......................................................................................................50 
11.1.1. 
Subject Inclusion Criteria for Observation .................................................................50 
11.1.2. 
Subject Exclusion Criteria for Observation ................................................................50 
11.2. 
Treatment ....................................................................................................................50 
11.2.1. 
Subject Inclusion Criteria for Treatment ....................................................................50 
11.2.2. 
Subject Exclusion Criteria for Treatment ...................................................................51 
11.3. 
Subject Discontinuation Criteria .................................................................................52 
11.3.1. 
Replacement Procedures .............................................................................................52 
12. 
PROCEDURES AND TREATMENTS .....................................................................53 
12.1. 
Study Visits .................................................................................................................53 
12.1.1. 
Subject Screening .......................................................................................................53 
12.1.2. 
Screening Assessments ...............................................................................................53 
12.1.3. 
Study Entry/Observational Assessments ....................................................................53 
12.1.3.1. 
Three-Month Assessments..........................................................................................53 
12.1.4. 
Treatment Assessments (Optional) .............................................................................54 
12.1.4.1. 
6FUHHQLQJ%'D\VíWRí5HODWLYHWR2SHQ-Label Treatment Visit Day 1) .........55 
12.1.4.2. 
Treatment Session 1 (Treatment Visit 1) ....................................................................56 
12.1.4.3. 
Treatment Session 2 (Treatment Visit 2/Day 22 ± 3 Days) and Treatment 
Session 3 (Treatment Visit 3/Day 43 ± 3 Days) .........................................................59 
12.1.4.4. 
Day 71 (+5 Days) End of Treatment/Early Termination ............................................60 
12.1.4.5. 
Follow-up Visits .........................................................................................................61 
12.2. 
Prior and Concomitant Medications and Procedures ..................................................61 
12.2.1. 
Prohibited Medications ...............................................................................................61 
12.2.2. 
Prohibited Procedures .................................................................................................61 
12.3. 
Treatment Compliance ................................................................................................61 
12.4. 
Blinding and Randomization ......................................................................................62 
12.5. 
End of Study ...............................................................................................................62 
13. 
ASSESSMENT OF EFFICACY ................................................................................63 
13.1. 
Primary Efficacy Measurements .................................................................................63 
13.1.1. 
Subject and Investigator Cellulite Assessments .........................................................63 
13.1.1.1. 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) ........................63 
13.1.1.2. 
Subject Global Aesthetic Improvement Scale (S-GAIS)............................................67 

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13.1.1.3. 
Subject Satisfaction with Cellulite Treatment Assessment ........................................67 
13.1.1.4. 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) ....................68 
13.1.1.5. 
Investigator Global Aesthetic Improvement Scale (I-GAIS) .....................................71 
13.1.1.6. 
Hexsel Cellulite Severity Scale ..................................................................................71 
14. 
ASSESSMENT OF SAFETY .....................................................................................73 
14.1. 
Definitions ..................................................................................................................73 
14.1.1. 
Adverse Event .............................................................................................................73 
14.1.2. 
Serious Adverse Event ................................................................................................73 
14.2. 
Monitoring Adverse Events ........................................................................................74 
14.3. 
Relationship to Study Drug ........................................................................................74 
14.4. 
Intensity Assessment ..................................................................................................75 
14.5. 
Reporting Adverse Events and Serious Adverse Events ............................................75 
14.5.1. 
Reporting Adverse Events ..........................................................................................75 
14.5.2. 
Reporting Serious Adverse Events .............................................................................75 
14.5.2.1. 
Follow-up Procedures for Serious Adverse Events ....................................................76 
14.6. 
Special Reporting Situations .......................................................................................76 
14.6.1. 
Adverse Events of Special Interest .............................................................................76 
14.6.2. 
Overdose/Misuse/Abuse .............................................................................................76 
14.6.3. 
Pregnancy ...................................................................................................................77 
14.6.4. 
Adverse Events/Serious Adverse Events Experienced by Non-subjects 
Exposed to Study Medication .....................................................................................77 
14.7. 
Clinical Laboratory and Immunogenicity Determinations .........................................77 
14.7.1. 
Anti-AUX-I and Anti-AUX-II Antibodies .................................................................78 
14.8. 
Vital Signs ..................................................................................................................79 
14.9. 
Electrocardiogram .......................................................................................................79 
14.10. 
Physical Examination .................................................................................................80 
14.11. 
Other Safety Assessments ...........................................................................................80 
15. 
ASSESSMENT OF PHARMACOKINETICS ...........................................................81 
16. 
ASSESSMENT OF PHARMACODYNAMICS ........................................................82 
17. 
STATISTICAL CONSIDERATIONS AND METHODS .........................................83 
17.1. 
Determination of Sample Size ....................................................................................83 
17.2. 
Subject Cohorts and Subject Populations ...................................................................83 
17.2.1. 
Observational Population ............................................................................................83 

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17.2.2. 
Safety Population ........................................................................................................83 
17.2.3. 
Effectiveness Population ............................................................................................84 
17.3. 
Subject Disposition .....................................................................................................84 
17.4. 
Demographics and Other Baseline Characteristics .....................................................84 
17.5. 
Efficacy Analyses .......................................................................................................84 
17.5.1. 
Efficacy Analysis ........................................................................................................85 
17.6. 
Safety Analyses ..........................................................................................................86 
17.6.1. 
Prior, Concomitant, and Follow-up Medication .........................................................86 
17.6.2. 
Study Drug Exposure ..................................................................................................87 
17.6.3. 
Measurement of Treatment Compliance ....................................................................87 
17.6.4. 
Adverse Events ...........................................................................................................87 
17.6.5. 
Vital Signs ..................................................................................................................87 
17.6.6. 
Clinical Laboratory Parameters ..................................................................................87 
17.7. 
Immunogenicity Analyses ..........................................................................................88 
17.8. 
Pharmacokinetic Analyses ..........................................................................................88 
17.9. 
Interim Analysis ..........................................................................................................88 
17.10. 
Statistical Software .....................................................................................................88 
18. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................89 
18.1. 
Study Drug Identity ....................................................................................................89 
18.2. 
Study Drug Packaging and Labeling ..........................................................................89 
18.3. 
Study Drug Storage .....................................................................................................89 
18.4. 
Study Drug Preparation ..............................................................................................89 
18.5. 
Study Drug Accountability .........................................................................................89 
18.5.1. 
Study Drug Handling and Disposal ............................................................................90 
19. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................91 
19.1. 
Source Documents ......................................................................................................91 
19.2. 
Study Monitoring ........................................................................................................91 
19.3. 
Audits and Inspections ................................................................................................91 
19.4. 
Institutional Review Board (IRB) ...............................................................................92 
19.5. 
Data Recording and Documentation ...........................................................................92 
20. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................93 
21. 
ETHICS ......................................................................................................................94 
21.1. 
Ethics Review .............................................................................................................94 

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21.2. 
Ethical Conduct of the Study ......................................................................................94 
21.3. 
Subject Information and Consent ...............................................................................95 
22. 
DATA HANDLING AND RECORDINGKEEPING ................................................96 
22.1. 
Data Collection ...........................................................................................................96 
22.2. 
Study Documentation .................................................................................................96 
23. 
REPORTING AND PUBLICATION .........................................................................97 
24. 
INVESTIGATOR OBLIGATIONS ...........................................................................98 
24.1. 
Regulatory Documents ...............................................................................................98 
24.2. 
Delegation of Responsibilities and Adequate Resources ...........................................99 
24.3. 
Medical Care of Study Subjects .................................................................................99 
24.4. 
Use of Investigational Materials .................................................................................99 
24.5. 
Retention of Records ..................................................................................................99 
24.6. 
Subject Confidentiality .............................................................................................100 
25. 
TERMINATION OF STUDY ..................................................................................101 
26. 
INVESTIGATOR’S AGREEMENT ........................................................................102 
27. 
REFERENCES .........................................................................................................103 
APPENDIX A. DOCUMENTS REQUIRED PRIOR TO INITIATION OF THE 
STUDY .....................................................................................................................105 
APPENDIX B. HEXSEL DM, DAL’FORNO T, HEXSEL CL. A VALIDATED 
PHOTONUMERIC CELLULITE SEVERITY SCALE. J EUR ACAD 
DERMATOL VENEREOL. 2009;23(5):523-528. .....................................................107 
APPENDIX C. REFERENCE IMAGES FOR HEXSEL SEVERITY RATINGS ..................115 
APPENDIX D. PATIENT INSTRUCTIONS FOR USE OF PATIENT-REPORTED 
PHOTONUMERIC CELLULITE SEVERITY SCALE (PR-PCSS) .......................116 
 

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LIST OF TABLES 
Table 1: 
Sponsor Contact Information ......................................................................................23 
Table 2: 
Observation Assessments ...........................................................................................30 
Table 3: 
Treatment Session Assessments .................................................................................31 
Table 4: 
Abbreviations and Specialist Terms ...........................................................................39 
Table 5: 
Concomitant Medication Restrictions for Subjects During the Treatment 
Phase of Study ............................................................................................................61 
Table 6: 
Subject Global Aesthetic Improvement Scale (S-GAIS)............................................67 
Table 7: 
Subject Satisfaction with Cellulite Treatment Assessment ........................................68 
Table 8: 
Investigator Global Aesthetic Improvement Scale (I-GAIS) .....................................71 
Table 9: 
Hexsel Cellulite Severity Scale ..................................................................................72 
Table 10: Clinical Laboratory Parameters ..................................................................................78 
Table 11: Vital Signs Measurements on Injection Day ..............................................................79 
 
LIST OF FIGURES 
Figure 1: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the 
Buttock ........................................................................................................................65 
Figure 2: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the 
Thigh ...........................................................................................................................66 
Figure 3: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for 
the Buttock ..................................................................................................................69 
Figure 4: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for 
the Thigh .....................................................................................................................70 
 
 

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7. 
LIST OF ABBREVIATIONS  
The following abbreviations and specialist terms are used in this study protocol. 
Table 4: 
Abbreviations and Specialist Terms 
Abbreviation 
Definition 
AE 
Adverse event 
Assigned quadrant 
Assigned quadrant (ie, left or right buttock, or the left or right posterolateral thigh) that 
was suitable for treatment and was randomly assigned in the double-blind study 
(EN3835-201). To be suitable for treatment the quadrant must have an Investigator 
CR-PCSS and subject PR-PCSS score of 3 or 4 and a Hexsel CSS score of no greater 
than 13 at Screening B visit and at Day 1 visit. 
AUX-I 
Clostridial class I collagenase 
AUX-II 
Clostridial class II collagenase 
CFR 
Code of Federal Regulations 
CRF 
Case report form 
CR-PCSS 
Clinician-Reported Photonumeric Cellulite Severity Scale 
CSS 
Cellulite Severity Scale 
DDE 
Direct data entry 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EFP 
Edematous fibrosclerotic panniculopathy 
FDA 
Food and Drug Administration 
GCP 
Good clinical practice 
HREC 
Human research ethics committee 
IB 
Investigator Brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent ethics committee 
I-GAIS 
Investigator Global Aesthetic Improvement Scale 
IND 
Investigational new drug 
IRB 
Institutional review board 
ITT 
Intent-to-treat 
kDa 
Kilodalton 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
Modified intent-to-treat 
PCS 
Potentially clinically significant 
PR-PCSS 
Patient-Reported Photonumeric Cellulite Severity Scale 
Qualified designee 
Qualified by education and training to perform the study procedure (eg, 
sub-Investigator, nurse) 

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Table 4: 
Abbreviations and Specialist Terms (Continued) 
Abbreviation 
Definition 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
Selected quadrant 
Quadrant (ie, left or right buttock, or the left or right posterolateral thigh) that is suitable 
for treatment and is selected by patient and investigator for treatment. To be suitable for 
treatment the quadrant must have an Investigator CR-PCSS and subject PR-PCSS score 
of at least 3 or 4 and a Hexsel CSS score of no greater than 13 at Screening B visit. 
S-GAIS 
Subject Global Aesthetic Improvement Scale 
TEAE 
Treatment-emergent adverse event; adverse events that occur on or after the first 
injection of study drug 
 

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8. 
INTRODUCTION 
8.1. 
Edematous Fibrosclerotic Panniculopathy 
Edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite, has been defined 
as a local metabolic disorder of subcutaneous tissues that results in an alteration of skin 
topography.(1) The condition manifests as dimpled skin, described as an orange-peel, cottage 
cheese, or mattress texture, particularly in the gluteal-femoral region.(2,3) EFP is caused by 
herniation of subcutaneous fat lobules through the dermohypodermal junction. This creates an 
uneven surface with dimpling.(1) EFP is a medical condition resulting in a potentially 
cosmetically unacceptable alteration of the skin, and affects an estimated 85% to 98% of 
postpubertal women.(1,3) 
The pathophysiology of EFP is not completely understood, but there are 3 main theories: edema 
resulting from excessive hydrophilia of the intercellular matrix, alteration of the regional 
microcirculation, and different anatomical conformation of collagenous subcutaneous tissues in 
women versus men.(4) 
It is known that EFP is different from generalized obesity. In generalized obesity, adipocytes 
undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs, and abdomen.(1) 
In areas of EFP, adipocytes have physiologic and biochemical properties that differ from adipose 
tissue located elsewhere. Large, metabolically-stable adipocytes characterize EFP-prone areas; 
thus, the responsiveness to catecholamine-induced lipolysis is less in EFP tissues compared to 
visceral fat, which has the greatest responsiveness.(1) 
Subcutaneous fat lobes are separated from one another by thin, usually rigid strands of 
collagenous connective tissues, which cross the fatty layers and connect the dermis to the 
underlying fascia. These septa stabilize the subcutis and divide the fat. In EFP, shortening of the 
collagen septa due to fibrosis provokes retraction at the insertion points of the trabeculae, 
causing the depressions that characterize EFP.(2) There are a higher percentage of thinner, 
perpendicular hypodermal septa in women with EFP than in men.(1) Weight gain makes EFP 
more noticeable, but it may be present even in thin subjects. Genetics may also play a role since 
EFP tends to run in families. 
8.2. 
Current Edematous Fibrosclerotic Panniculopathy Treatments 
There are therapies that have been utilized in an attempt to treat cellulite. Despite multiple 
therapeutic modalities, there is little scientific evidence that any of these treatments are 
beneficial. In fact, much of the evidence is anecdotal, subjective, or based only on patient self-
assessment.(5) Some of the historical treatments for EFP have included: 
x Weight loss: Weight loss generally decreases the severity of EFP but may only have a 
variable effect on EFP grades.(6) 
x Pharmacological agents (eg, xanthines, retinoids, lactic acid, and herbals): Although 
there are numerous topical treatments that are available over the counter, there are no 
well-designed or large-scale studies demonstrating the effectiveness of any of these 

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therapies.(5) Additionally, ingredients in some of the topical treatments are unknown 
and may pose an increased risk for adverse effects.(5) 
x Massage: Endermologie or lipomassage kneads the skin between rollers. This type of 
vigorous massage is posited to increase blood flow and reduce excess fluid in EFP 
prone areas. In a 12-week, randomized, controlled study of 52 women that examined 
the effectiveness of either endermologie or aminophylline versus a combination of 
both, there was no statistical difference in the thigh measurement between 
subjects.(7) 
x Liposuction: Liposuction can reshape the body, but it does not typically correct 
cellulite as it does not interrupt collagen septae in a directed fashion. Additionally, 
liposuction is not a recommended treatment for cellulite given the potential for poor 
cosmetic outcome.(5,6) 
x Mesotherapy: Mesotherapy involves injecting solutions containing various 
substances, eg, methylxanthines, to dissolve subcutaneous fat; however, this type of 
therapy often results in unwanted side effects, including infection, urticarial reactions, 
and bumpy or uneven skin contours.(6) To date, there are no regulatory approved 
mesotherapy mixtures for the treatment of EFP. 
x Radiofrequency: Radiofrequency systems may temporarily improve the appearance of 
EFP after a series of treatments; but long-term efficacy has not been demonstrated.(6) 
x Subcision: Subcision is an invasive surgical technique that severs the septa holding 
fat lobules that cause the skin dimpling associated with EFP. In a study conducted by 
Hexsel and Mazzuco, 232 subjects had subcision for the treatment of EFP.(8) 
Although 78% of subjects were satisfied after 1 treatment, there were no objective 
criteria by which to assess improvement, thereby limiting the value of this study. 
Additionally, side effects reported in this study included pain, bruising for 3 to 
6 months, hyperpigmentation for 2 to 10 months, and skin puckering.(5,6) These 
effects are most likely due to the trauma from shearing the septa with a large gauge 
needle (eg, 16 or 18 gauge) or other cutting devices. 
x Powered subcision: Powered subcision is a surgical technique utilizing a powered 
needle apparatus to sever the septa holding fat lobules that cause skin dimpling 
associated with EFP. The Cellfina® powered subcision device was recently approved 
by Food and Drug Administration (FDA; 2015) for the treatment of cellulite. 
x Laser: Intense pulsed light has been investigated for the treatment of cellulite. 
Triactive® is an FDA-approved low-fluorescence 810-nm light source combined with 
a 915-nm laser. In a study of 16 female subjects who underwent 12 treatments with 
the Triactive, 21% had improvement (based on 5 blinded Investigators’ analysis of 
photographs with respect to appearance of cellulite, skin tone, and texture) of their 
cellulite.(9) The CelluLaze™ system was used to treat cellulite on the thighs of 
10 healthy women.(10) In this Investigator-initiated study, subjects received a single 
treatment with a 1440-nm laser. During the CelluLaze procedure, which is performed 
under a local tumescent and general anesthetic, the physician inserts a small cannula 
through the skin and the device technology directs controlled, laser thermal energy to 

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the treatment zones. The laser is designed to diminish the lumpy pockets of fat by 
melting the hypodermal fat; release the areas of skin depression through thermal 
subcision of the septal tissue; and increase the elasticity and thickness of the skin by 
melting the fat in the dermal invaginations. Subjective physician and subject 
evaluations indicated improvement in the appearance of cellulite and high patient 
satisfaction that persisted for a year. For both the Triactive and CelluLaze studies, 
there were no control groups and significance was not tested.  
There remains an unmet medical need for safe and effective nonsurgical therapies to improve the 
esthetic outcome in women with cellulite. To effectively treat cellulite, a therapeutic approach 
may require disruption of the dermal septa, which are composed of collagen and cause the skin 
dimpling which is bothersome to many women. 
8.3. 
EN3835 (Collagenase Clostridium Histolyticum) 
Endo Pharmaceuticals Inc. (Endo) is developing EN3835 for the treatment of EFP. Because 
EN3835 is a proteinase that can hydrolyze the triple-helical region of collagen under 
physiological conditions, EN3835 has the potential to be effective in lysing subdermal collagen, 
such as those observed in the dermal septa, which are the underlying cause of the skin dimpling 
in women with EFP. EN3835 targets the collagenase structural matrix (eg, dermal septa) at the 
site of injection and does not require systemic exposure to be effective. 
EN3835 is a parenteral lyophilized product comprised of 2 collagenases in an approximate 
1:1 mass ratio, Collagenase I (AUX-I, Clostridial class I collagenase) and Collagenase II 
(AUX-II; Clostridial class II collagenase). These collagenases are isolated and purified from the 
fermentation of Clostridium histolyticum. Collagenase AUX-I is a single polypeptide chain 
containing approximately 1,000 amino acids of known sequence and with a molecular weight of 
114 kDa. Collagenase AUX-II is also approximately 1,000 amino acids long and has a molecular 
weight of 113 kDa. These 2 collagenases are not immunologically cross-reactive and have 
different specificities, such that together they become synergistic, providing a very broad 
hydrolyzing reactivity toward collagen. Clostridial collagenases are proteinases that can 
hydrolyze the triple-helical region of collagen under physiological conditions. 
EN3835 is currently approved for: 1) the treatment of adults with Dupuytren’s contracture with a 
palpable cord and, 2) for the treatment of adult men with Peyronie’s disease with a palpable 
plaque and curvature deformity of at least 30 degrees at the start of therapy. 
8.3.1. 
Studies with EN3835 for the Treatment of Edematous Fibrosclerotic 
Panniculopathy 
The studies summarized in this section are described in more detail in the Investigator’s 
Brochure (IB). 
8.3.1.1. 
Investigator-Initiated Proof-of-Concept Study 
In an Investigator-initiated pilot study, 10 female subjects received EN3835 in the treatment of 
cellulite.(11) A 10×10-cm oval area was outlined on the posterolateral thigh and 0.58 mg 
EN3835 was injected using a template as 5 concurrent subcutaneous injections of 0.116 mg per 
injection. Subjects were followed up to 180 days after injection for reduction of the cellulite 
appearance in the injected area. At 1 month post injection, the area of cellulite (as measured from 

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photographs) was reduced 89% from baseline. Patient satisfaction score was 1.75 at month 6 
(1=completely satisfied, 4=not satisfied). Side effects included the local events of injection area 
soreness, ecchymosis, and mild edema; these resolved within a mean of 18 days. The results 
from this study suggest that the collagen septa of EFP may be an appropriate substrate for lysis 
with injectable collagenase, and that treatment with collagenase appears to be tolerable and 
possibly effective. However, due to the paucity of the data, no conclusions could be drawn 
regarding dose, frequency, and injection technique. 
8.3.1.2. 
Endo-Sponsored Phase 1b Dose-Escalation Study AUX-CC-830 
A dose-ranging Phase 1b dose escalation study (AUX-CC-830) used a template arrangement of 
injections as was used in the Investigator-initiated pilot study but injected a matrix of doses, 
concentrations and injectate volumes to select doses for further development. This Phase 1b 
study showed efficacy results suggesting that collagenase clostridium histolyticum (CCH) may 
be effective in the treatment of EFP based on global aesthetic improvement at Day 90 with 
ratings of “improved” by 43.4% of Investigators and 52.5% of subjects. The majority of 
subjects (71.7%) were “quite satisfied” or “very satisfied” with treatment on Day 90. Adverse 
events (AEs) were local injection site events (bruising, pain, erythema, and edema) were mild or 
moderate and resolved within a period of 3 weeks. 
8.3.1.3. 
Endo-Sponsored Phase 2a Dose-Ranging Study AUX-CC-831 
The Phase 2a study (AUX-CC-831) was a double-blind, placebo-controlled, dose-ranging study 
of 150 women randomized to 0.06, 0.48, or 0.84 mg of CCH; or placebo in a 5:5:5:3 ratio. Each 
subject could receive up to 3 treatment sessions of study drug separated by approximately 
21 days. Efficacy in this study was evaluated based on Investigator Global Aesthetic 
Improvement Scale (GAIS-I) and Subject Global Aesthetic Improvement Scale (GAIS-S) along 
with other measures of treatment efficacy. Improvements were observed in cellulite appearance 
based on the statistically significant changes in the appearance of cellulite based on both the 
GAIS-I and GAIS-S scores for the high and mid doses compared to placebo (p<0.05). The 
majority of the patients were either satisfied or very satisfied with the results of their cellulite 
treatment with the mid and high doses compared to placebo (p<0.05). Similar to the AEs 
reported in subjects in the previous study (AUX-CC-830) and subjects who received EN3835 for 
Dupuytren’s contracture and Peyronie’s disease, the majority of AEs occurred at the site of 
injection and resolved before the next scheduled treatment session. 
8.3.1.4. 
Endo-Sponsored Phase 2b Study EN3835-201 
Currently there is an ongoing Phase 2b study (EN3835-201) which is a double-blind, placebo-
controlled study of 350 adult women randomized to EN3835 0.84 mg or placebo in a 1:1 ratio. 
Each subject can receive up to 3 treatment sessions of study drug separated by approximately 
21 days; last visit is Day 71. Efficacy is being evaluated using a Clinician-Reported 
Photonumeric Cellulite Severity Scale (CR-PCSS), a Patient-Reported Photonumeric Cellulite 
Severity Scale (PR-PCSS), the Hexsel Cellulite Severity Scale (CSS), Investigator Global 
Aesthetic Improvement Scale (I-GAIS), Subject Global Aesthetic Improvement Scale (S-GAIS), 
and a subject satisfaction assessment. Subjects that complete study EN3835-201 will be offered 
the option of participating in study EN3835-202. 

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8.4. 
Summary of Nonclinical Studies 
Nonclinical studies necessary to support clinical studies have been performed and are 
summarized in the IB. Nonclinical studies in the following areas were performed: toxicology, 
reprotoxicity, genotoxicity, and carcinogenicity.  
8.5. 
Summary of Known Risks and Benefits 
A summary of safety risks is provided in the IB. The following events have been commonly 
observed in prior studies: injection site AEs such as bruising, edema, erythema and pain. 
There are previously generated potential clinical benefits associated with EN3835 in treating 
EFP, however, such potential benefits need further clinical evaluation. It is hoped that data from 
this clinical study will demonstrate a measurable sustained or durable clinical benefit of EN3835 
in EFP as well as longer term safety.  
8.6. 
Rationale 
This study will allow an evaluation of longer term safety (over 12 months) following EN3835 
treatment of subjects with EFP. Additionally, although uncontrolled, an assessment of cellulite 
assessments (efficacy) of EN3835 in the treatment of quadrants with moderate or severe cellulite 
will be conducted in subjects treated with placebo or EN3835 in the previous double-blind study 
(EN3835-201). The safety of re-dosing either in a previously treated quadrant (termed 
re-treatment) or in a naive quadrant (termed re-dosing) in subjects that previously received 
EN3835 treatment in study EN3835-201 will be assessed. Finally, the durability of improvement 
will be evaluated in enrolled subjects following EN3835 treatment in the double-blind study 
(EN3835-201) as well as those being treated with EN3835 in this open-label study 
(EN3835-202). 
 

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9. 
OBJECTIVES 
9.1. 
Primary Objective 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at scheduled 
intervals over 1 year (12 months) in all subjects with EFP who elect to enroll in this open-label 
trial regardless of their decision to receive treatment (re-treatment or re-dosing) of open-label 
EN3835 or opt to receive no treatment.  
9.2. 
Secondary Objectives 
x To evaluate safety and immunogenicity of re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
x To evaluate the durability of response to EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects previously receiving active treatment in 
study EN3835-201 using the PR-PCSS and the CR-PCSS 
x To evaluate long-term response to EN3835 in assessments of EFP including subject 
satisfaction, I-GAIS, and S-GAIS 
x To assess cellulite severity assessments in quadrants treated in this study with 
EN3835 
x To evaluate immunogenicity after exposure to EN3835 
9.3. 
Exploratory Objectives 
There are no exploratory objectives for this open-label extension study. 
 

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10. 
INVESTIGATIONAL PLAN 
10.1. 
Study Design 
This open-label extension study will be performed at multiple centers currently participating in 
the double-blind, placebo-controlled, parent trial (EN3835-201) in the United States. The open-
label extension study will enroll up to 350 subjects. Subjects who completed the entire double-
blind study and sign an informed consent will be eligible to enter this open-label extension.  
After the Sponsor has broken the EN3835-201 study drug blind, subjects enrolled in the open-
label study will have the following options: 
x To have no EN3835 treatments in study EN3835-202 
x If received EN3835 in study EN3835-201, may elect to have a qualifying quadrant 
other than the one treated in study EN3835-201 treated with EN3835 (termed 
re-dosing) 
x If received EN3835 in study EN3835-201 and the cellulite severity scores of the 
treated quadrant have returned to or are greater than EN3835-201 baseline scores, 
may elect to have the previously treated quadrant retreated with EN3835 (termed 
re-treatment) 
x If received placebo in study EN3835-201, may elect to have a qualifying quadrant 
treated with EN3835; also may elect to have a second qualifying quadrant treated 
with EN3835 after completing the treatment course  
Subjects enrolled in study EN3835-202 who elect to receive EN3835 treatment (either 
re-treatment, re-dosing, or a first treatment) must meet specific inclusion and exclusion criteria 
for eligibility during re-screening (Screening B) prior to EN3835 dosing.  
Following completion of safety and cellulite assessments at Day 71 of the double-blind study 
(EN3835-201), subjects will be asked if they wish to continue in the open-label extension to the 
double-blind study (Screening A). At the time of entry into the open-label study, subjects and 
Investigators will remain blinded to study drug. Until the EN3835-201 study drug blind is broken 
by the Sponsor, subjects will undergo observation-only visits at 3-month intervals ± 7 days 
(relative to the initial dose in the double-blind study) where both safety and cellulite severity 
assessments of the treated quadrant will be made. 
Following the study drug blind being broken and communicated to centers, eligible subjects may 
elect to receive EN3835 treatment. Subjects electing not to receive further EN3835 treatments 
(observation-only subjects) will continue to be followed for safety and cellulite severity 
assessments at 3-month intervals through month 12. Up to 14 days prior to initiating treatment 
injections of EN3835 on open-label treatment visit Day 1, subjects will undergo a screening 
evaluation (Screening B) to determine if they meet specified inclusion and exclusion criteria and 
to determine the quadrants, if any, that qualify for treatment.  
During Screening B, photographs will be taken of each of the subject’s 4 quadrants (left buttock, 
right buttock, left posterolateral thigh, and right posterolateral thigh). Subjects will again receive 
instructions for use of the PR-PCSS and will subsequently use the scale to rate the severity of 

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their cellulite in each of the 4 quadrants by comparing digital images of each of their quadrants 
displayed on standardized computer monitors with the PR-PCSS instrument. This independent 
self-assessment will take place in a private setting to minimize any potential bias from site 
personnel. The Investigator will then assess the subject’s 4 quadrants live in real-time using the 
CR-PCSS. The Investigator will rate the 4 quadrants using the Hexsel CSS as described in 
section 13.1.1.6.(12) Subjects must have at least 1 quadrant that meets the following criteria for 
inclusion into the treatment phase of the study: 
1. PR-PCSS score of 3 or 4, and 
2. CR-PCSS score of 3 or 4, and  
3. Hexsel CSS score of no greater than 13. 
After the independent assessments are completed separately by the subject and the Investigator, 
the Investigator will review his/her assessments and the subject’s assessment to determine which 
quadrants, if any, are eligible. The eligible quadrant chosen to receive treatment in the open-label 
study EN3835-202 will be at the discretion of the subject. A quadrant may be chosen for 
re-treatment if it was the quadrant treated in study EN3835-201 or a new quadrant may be 
chosen for re-dosing. NOTE: For subjects who received active drug in the assigned 
quadrant in the double-blind study, the quadrant must have cellulite severity at (or 
greater) than the EN3835-201 baseline scores of PR-PCSS and CR-PCSS to qualify for 
re-treatment. 
Previously placebo-treated subjects will have the option to receive a second course of EN3835 in 
the same or different qualifying quadrant after at least 28 days following the end of the first 
treatment course (eg, the screening B visit of second quadrant could be performed on Day 71 
after treating the first quadrant). The selected quadrant can be re-treated or re-dosed.  
At each treatment session visit, Investigators will select the dimples within the chosen quadrant 
to be treated. Selection of dimples to be treated in the quadrant will be at the discretion of the 
Investigator. The selected EFP dimples in the selected quadrant must be well-defined and evident 
when the subject is standing in a consistent relaxed pose (without the use of any manipulation 
such as skin pinching or muscle contraction). The dimples selected to be treated will be circled 
with a surgical marker and injection site locations should be marked with a dot; if more than 
1 injection per dimple is needed, the injection sites should be separated by approximately 2 cm. 
The selected quadrant will be photographed again after marking dimples. Subjects will be 
administered a maximum of EN3835 0.84 mg from a total of up to 12 injections. Up to 
12 injections will be administered at each treatment session to treat the selected quadrant. Each 
of the injections will be administered as three 0.1-mL aliquots (total injection volume per 
injection is 0.3 mL; total injection volume per treatment session is 3.6 mL [12 injections × 
0.3 mL], see table below).  
Subjects will receive 3 treatment sessions (Day 1, Day 22, and Day 43) unless the chosen 
quadrant has no further treatable EFP dimples and the Investigator rates the quadrant a score of 0 
on the CR-PCSS. The same dimples within a quadrant or different dimples within a quadrant 
may be treated at each session but injections must all be within the selected quadrant for all 
3 sessions. Each treatment session will be separated by approximately 21 days. 

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Dose per 
Each Injectiona 
Injection 
Volume per 
Each Injection 
Maximum 
Number of 
Injections per 
Each Treatment 
Session 
Maximum Dose 
(mg) per Each 
Treatment 
Session 
Maximum 
Injection Volume 
(mL) per Each 
Treatment 
Session 
Maximum 
Cumulative EFP 
Dose 
EN3835 0.07 mg 
0.3 mL 
12 injections  
0.84 mg 
(12 injections  
× 0.07 mg) 
3.6 mL 
(12 injections  
× 0.3 mL) 
2.52 mg 
(3 treatment sessions 
× 0.84 mg) 
a Each injection of EN3835 is 0.3 mL administered as three 0.1-mL aliquots.  
The complete Schedule of Events is provided in section 5 (Table 2 and Table 3) and summarized 
in section 12. 
10.2. 
Selection of Doses 
Maximum possible doses of EN3835 employed will be the same as that administered in the 
double-blind, placebo-controlled, parent study (EN3835-201). 
10.3. 
Study Drug Administration 
Study drug in the form of sterile vials of lyophilized EN3835 (formerly AA4500) and sterile 
diluent will be provided by Endo. Study drug administration at each injection site is presented in 
section 12.1.4.2. 
10.4. 
Discussion of Study Design, Including the Choice of Control Groups 
The use of the open-label extension design allows for the following: 
x Safety data over a 12-month period will be collected to assist in further defining the 
safety profile of EN3835 in this population, 
x Safety data and immunogenicity after repeat exposure (re-treatment/re-dosing) and 
monitoring of previously active-treated subjects to EN3835 over a 12-month period,  
x Previously placebo-treated subjects to have exposure to EN3835, and  
x Durability of the response to EN3835 (cellulite severity assessments) will be 
assessed.  

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11. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
11.1. 
Observation Phase 
All subjects who have completed the double-blind study EN3835-201 and sign the informed 
consent are eligible for enrollment in this open-label extension study and participation in the 
ongoing safety and cellulite evaluations.  
11.1.1. 
Subject Inclusion Criteria for Observation 
To qualify for this open-label observation study a subject must: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201  
3. Be willing to apply sunscreen to any treated quadrant before each exposure to the sun 
while participating in the study (ie, screening through end of study) 
11.1.2. 
Subject Exclusion Criteria for Observation 
None 
11.2. 
Treatment 
Inclusion and exclusion criteria presented in section 11.2 apply only to those subjects in the 
open-label study who choose treatment. 
At the time that the study drug blind is broken in the double-blind study EN3835-201, qualified 
subjects enrolled in the open-label study are eligible for treatment. A subject may participate in 
the observational period of this open-label study regardless of scoring of quadrant; however to 
receive treatment in this study, a subject must have at least 1 qualifying quadrant. 
11.2.1. 
Subject Inclusion Criteria for Treatment 
To qualify for treatment in the study a subject must: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be a female 8 years of age 
4. At Screening B visit, have at least 1 quadrant with: 
a. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 
b. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and 
c. a Hexsel CSS score no greater than 13 
5. Be willing to apply sunscreen to the selected treatment quadrant before each exposure to 
the sun while participating in the study (ie, Screening B through end of study) 
6. Be judged to be in good health, based upon the results of a medical history, physical 
examination, and laboratory profile at Screening B 

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7. Have a negative urine pregnancy test at Screening B and before injection of study drug 
and be using an effective contraception method (eg, abstinence, intrauterine device 
[IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at 
least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be 
menopausal defined as 12 months of amenorrhea in the absence of other biological or 
physiological causes, as determined by the Investigator; or post-menopausal for at least 
1 year; or be surgically sterile 
8. Be willing and able to cooperate with the requirements of the study 
9. Be able to read, complete and understand the patient-reported outcomes rating 
instruments in English 
11.2.2. 
Subject Exclusion Criteria for Treatment 
A subject will be excluded from treatment in the study (but not from the observation 
assessments) if she: 
1. Has used any of the following for the treatment of EFP on the legs or buttock within the 
timelines identified below or intends to use any of the following at any time during the 
course of the study: 
x Liposuction on the side of the body selected for treatment during the 12-month period 
before injection of study drug 
x Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or 
surgery (including subcision and/or powered subcision) within the selected treatment 
quadrant during the 12-month period before injection of study drug 
x Endermologie or similar treatments within the selected treatment quadrant during the 
6-month period before injection of study drug 
x Massage therapy within the selected treatment quadrant during the 3-month period 
before injection of study drug 
x Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected 
treatment quadrant during the 2-week period before injection of study drug 
2. Is presently nursing a baby or providing breast milk for a baby 
3. Intends to become pregnant during the study 
4. Has received an investigational drug or treatment within 30 days before injection of study 
drug 
5. Has a known systemic allergy to collagenase or any other excipient of study drug 
6. Is currently receiving or plans to receive anticoagulant or antiplatelet medication or has 
receiYHGDQWLFRDJXODQWRUDQWLSODWHOHWPHGLFDWLRQH[FHSWIRU mg aspirin daily) 
within 7 days before injection of study drug 
7. Has a known recent history of stroke, bleeding, or other medical condition, which in the 
investigator’s opinion would make the subject unsuitable for enrollment in this phase of 
the study 

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8. Presence of any clinically relevant conditions, that in the opinion of the Investigator 
would interfere with completing the study including, but not limited to, visual problems, 
hearing problems, cognitive impairment or acute mental illness 
11.3. 
Subject Discontinuation Criteria 
A premature discontinuation will occur when a subject who signed informed consent ceases 
participation in the study, regardless of circumstances, prior to the completion of the protocol. 
Subjects can be prematurely discontinued from the study for one of the following reasons: 
x An adverse event (AE) 
x A protocol violation (reason must be specified, for example: lack of compliance, use 
of a prohibited concomitant medication, failure to meet inclusion/exclusion criteria 
after study entry, etc) 
x Withdrawal by subject (reason must be specified) 
x The subject was “lost to follow-up”  
x Other reasons (reason must be specified, for example: the subject moved, pregnancy, 
investigator decision, Sponsor decision to terminate trial, etc) 
If a subject discontinues from the study, all end-of-study procedures should be conducted as 
detailed in Schedule of Events. The date a subject discontinues and the reason for 
discontinuation will be recorded in the source documentation and Electronic Case Report Form 
(eCRF). If, however, a subject withdraws consent, no end-of-study procedures are required 
except the collection of AE information. This information should be recorded in the source 
documentation and the eCRF.  
11.3.1. 
Replacement Procedures 
Subjects who discontinue prematurely from the study will not be replaced. 

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12. 
PROCEDURES AND TREATMENTS 
12.1. 
Study Visits 
The Schedule of Events to be performed at each visit is shown in section 5. Provided below are 
further details where additional instruction about the assessments that will be performed is 
deemed to be needed. 
12.1.1. 
Subject Screening 
Upon completion of Day 71 assessments in the double-blind study EN3835-201, a subject will 
be eligible to enter this open-label extension study. All potential subjects eligible for screening in 
EN3835-202 will be pre-populated in the electronic data capture (EDC) system. The status of all 
subjects (eg, screen fails) will also be kept in the EDC system. 
12.1.2. 
Screening Assessments 
After obtaining informed consent, the full assessment of eligibility will be conducted and prior to 
study entry, screening assessments will be performed. Details about how the informed consent 
will be obtained and documented are provided in section 21.3, Subject Information and Consent. 
The subject may be entered into the observational phase of the study and complete safety and 
cellulite severity assessments at 3-month intervals as detailed in Table 2. In addition, once the 
study blind is broken in study EN3835-201, enrolled subjects will be asked if they wish to 
receive additional open-label treatments. If a subject elects to receive open-label treatment, study 
assessments will be conducted in accordance with Table 3. 
12.1.3. 
Study Entry/Observational Assessments 
A subject who gives written informed consent and who satisfies all eligibility criteria 
(section 11) may be entered into the observational phase of the study and complete safety and 
cellulite severity assessments at 3-month intervals as detailed in Table 2. The first visit will be 
determined by the date of enrollment in study EN3835-202 relative to the Schedule of Events for 
study EN3835-202 (Table 2). For example, if a subject enrolls after the Day 90 visit window, the 
first observation visit for that subject would be Day 180. In addition, once the study drug blind is 
broken in study EN3835-201, enrolled subjects will be asked if they wish to receive additional 
open-label treatments. If a subject elects to receive open-label treatment, study assessments will 
be conducted in accordance with Table 3. The subject identification number will be carried over 
from the double-blind, placebo-controlled study (EN3835-201). All subjects must complete 
Screening A and at least 1 Observation visit before Screening B can occur. Once the study blind 
was broken, the EN3835-201 placebo subjects were allowed to directly proceed to Screening B. 
12.1.3.1. Three-Month Assessments 
Subjects will return within 20 days (±4 days) of completion of the double-blind study for the first 
of 4 safety and cellulite severity evaluation visits. Assessments to be completed at these visits are 
detailed in Table 2. Subjects are to return at 3-month intervals until they have completed 
12 months from Day 1 of the double-blind study. At these visits, the quadrant previously treated 
with EN3835 in the EN3835-201 study or quadrants treated with EN3835 in the open-label study 

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will be evaluated. If the quadrant treated in study EN3835-201 is retreated in the open-label 
study, the 3-month assessments will reset to treatment visit 1/Day 1 of the open-label treatment 
and the study visits will continue as described in Table 3 followed by 3-month assessments as 
described in Table 2. If a different quadrant is treated in the open-label study, the 3-month 
assessments of both the quadrant treated in the double-blind study (EN3835-201) and the 
quadrant treated in the open-label study will continue. 
12.1.4. 
Treatment Assessments (Optional) 
After unblinding of treatment assignment in the EN3835-201 study, subjects are eligible for 
optional treatment in the open-label study, provided they meet the inclusion and exclusion 
criteria detailed in section 11 and at least 1 quadrant meets the criteria for treatment. A subject 
may receive a maximum of 2 courses of treatment (6 treatment sessions) overall (total of 
treatments in double-blind and open-label study). If a subject received placebo in the double-
blind study, she may be eligible for 2 treatment courses in the open-label study; if a subject 
received active drug in the double-blind study, she may be eligible for 1 additional treatment 
course (3 treatment sessions) in the open-label study.  
Selection of Treatment Quadrant 
During the Screening B visit, each subject will have photographs taken of the 4 targeted 
quadrants of the study (eg, their left and right buttocks and left and right posterolateral thighs). 
Subjects will receive instructions (Appendix D) for using the PR-PCSS and will use the scale to 
rate the severity of their cellulite in each of the 4 quadrants by comparing each of their digital 
image photographs with the PR-PCSS instrument. This self-assessment will take place in a 
private setting to minimize any potential bias from site personnel. The Investigator will then 
assess each of the subject’s 4 quadrants live in real-time using the CR-PCSS. The Investigator 
will then examine each of the 4 quadrants live to assess the subject using the Hexsel CSS as 
described in section 13.1.1.6.(12) Subjects must have at least 1 quadrant that meets the following 
criteria for treatment in the study: 
1. PR-PCSS score of 3 or 4, and 
2. CR-PCSS score of 3 or 4, and  
3. Hexsel CSS score no greater than 13.  
After the independent assessments are completed separately by the subject and the Investigator, 
the Investigator will review his/her assessments and the subject’s assessment to determine which 
quadrants, if any, are eligible. The eligible quadrants (must meet all 3 of the inclusion criteria 
(PR-PCSS, CR-PCSS, and Hexsel CSS scores), if any, for treatment will be determined by the 
Investigator after which the quadrant selected will be at the discretion of the subject. For subjects 
treated with EN3835 in the double-blind study, if the quadrant treated in the double-blind study 
(EN3835-201) has PR-PCSS and CR-PCSS ratings identical or more severe than the double-
blind study (EN3835-201) PR-PCSS and CR-PCSS baseline ratings (Baseline is Day 1 of study 
EN3835-201), subjects can elect to have that same quadrant re-treated. Subjects who choose 
re-treatment of the previously treated quadrant will be classified in the re-treatment arm. If 
another quadrant besides the previously treated quadrant meets all 3 of the inclusion criteria, 
subjects can choose to be treated in the naive quadrant. Subjects who choose treatment into a 
naive quadrant will be classified in the re-dosing arm. 

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Assessments made with the PR-PCSS (from digital image), the CR-PCSS (live assessment), and 
the Hexsel CSS score during the open-label Screening B visit will be the baseline severity of 
EFP in the selected quadrant.  
A subject who received placebo in the double-blind study may be treated in the same quadrant in 
the open-label study if the quadrant still meets all 3 criteria OR another qualifying quadrant may 
be selected for treatment by the subject. Following Day 71 of a treatment course (3 treatment 
sessions), subjects can choose to receive a second treatment session in either the same quadrant if 
it still meets qualification criteria or in a different quadrant that meets qualification criteria. For 
the first treatment course, these subjects will be considered in the treatment arm. For the second 
treatment course, if the same quadrant is treated, subjects will be in the re-treatment arm; if a 
different quadrant is treated, subjects will be considered in the re-dosing arm.  
If no quadrant meets all 3 criteria, the subject may continue in the observation-only study with 
safety and cellulite severity evaluations performed at 3-month intervals but may not receive 
treatment in this study. 
Selecting and Marking Dimples 
Selection of dimples to be treated in the selected quadrant is at the discretion of the Investigator 
or qualified designee. Dimples must be well-defined and evident when the subject is standing in 
a consistent relaxed pose (without the use of any manipulation such as skin pinching or muscle 
contraction). Each subject will receive 3 treatment sessions of study drug in the selected 
quadrant. During each treatment session, the treatment quadrant will be photographed before and 
after dimple marking while the subject is standing in a consistent relaxed pose as described in the 
Photography Manual. The cellulite severity assessments using the PR-PCSS and CR-PCSS will 
be completed prior to dimple marking at treatment visits 2, 3, and 4/end of treatment. 
12.1.4.1. Screening B (Days í14 to í1 Relative to Open-Label Treatment Visit Day 1) 
Subjects meeting the relevant criteria listed in section 11.2 may be eligible for treatment in the 
open-label study. The following procedures will be performed and documented during the 
screening period: 
1. Evaluate eligibility based on inclusion/exclusion criteria (section 11.2) 
2. Subject will have digital photographs taken of the 4 targeted quadrants of the study (left 
and right buttocks, and left and right posterolateral thighs) (section 13.1) 
3. Subjects will get instruction on the use of the PR-PCSS (Appendix D) 
4. Subjects will rate each quadrant using the PR-PCSS while viewing their digital images 
(section 13.1.1.1) 
5. The Investigator will conduct independent live assessments of subject’s cellulite severity 
of each quadrant using the CR-PCSS (section 13.1.1.4) after the subject completes her 
rating and with no knowledge of the subject's ratings of her quadrants. 
6. The Investigator will conduct live cellulite evaluation of each quadrant using the Hexsel 
CSS (section 13.1.1.6).  

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7. If at least 1 quadrant qualifies based on PR-PCSS, CR-PCSS, and Hexsel CSS ratings, 
subject may return for treatment on treatment visit 1. If none of the 4 quadrants qualify, 
the subject may remain in the study and have safety and cellulite severity evaluations 
performed at 3-month intervals but is not eligible for treatment. 
8. Subject will select an eligible quadrant (based on qualifying scores) to be treated at their 
discretion. 
9. Medical history including EFP history. Medical history will be based on EN3835-201 
eCRF; only updates to the history need to be captured at Screening B visit. 
10. Record prior and concomitant medications/procedures. Prior medications will be based 
on EN3835-201 eCRF; only updates and concomitant medications need to be captured at 
Screening B visit (section 12.2). 
11. Physical examination including measurement of body weight and height (section 14.10)  
12. Vital sign measurements (section 14.8) 
13. 12-lead electrocardiogram (ECG), not necessary if the date of the ECG obtained during 
the double-blind study (EN3835-201) is within 12 months of the date of the Screening B 
visit (section 14.9) 
14. Collection of samples for: 
a. Clinical laboratory testing (section 14.7) 
b. Urine pregnancy testing (section 14.7) 
15. Adverse events (section 14) 
12.1.4.2. Treatment Session 1 (Treatment Visit 1)  
Pre-injection 
1. Confirm eligibility criteria (section 11) 
2. Take digital photography of selected quadrant before dimple marking (section 13.1) 
3. Record concomitant medications/procedures (section 12.2) 
4. Vital sign measurements (section 14.8)  
5. Collection of samples for:  
a. anti-AUX-I and anti-AUX-II antibody testing (section 14.7.1) 
b. urine pregnancy testing (section 14.7) 
6. Select and mark dimples to be treated (section 12.1.4) 
7. Take digital photograph of selected quadrant after dimple marking (section 13.1) 
Injection 
Administration of study drug in the prone position (see below) 

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Post-injection 
1. Record number of dimples treated and number of injections administered 
2. Vital sign measurements (section 14.8) 
3. Injection site reactions and local tolerability 
4. Adverse events (section 14) 
The selected quadrant will be photographed before and after dimple marking while the subject is 
standing in a consistent relaxed pose as described in the Photography Manual. Before injection at 
treatment session 1, the Investigator or qualified designee will begin the session by selecting 
dimples within the chosen quadrant that are well defined, evident when the subject is standing, 
and suitable for treatment; treatment consists of up to 12 injections per session. Because the goal 
of treatment is to improve the aesthetic appearance of the entire quadrant, the Investigator will be 
instructed to select dimples that in his or her opinion would most improve the aesthetic 
appearance of the entire quadrant. The same dimples within a quadrant or different dimples 
within a quadrant may be treated at each session but injections must all be within the selected 
quadrant for all 3 sessions. 
For each dimple selected for treatment, the Investigator or qualified designee will choose 
injection sites (injection sites within a dimple should be spaced approximately 2 cm apart, if a 
dimple requires more than 1 injection). Each injection site will be marked with a “dot” using a 
surgical marker. For round dimples, the “dot” will be placed in the center of the dimple; for 
elongated dimples, “dots” will be spaced out approximately 2 cm along the longer axis of the 
dimple. The Investigator or qualified designee will then use a surgical marker to circle each of 
the dimples selected for treatment. Circles in the selected quadrant should not overlap.  
Examples of subject dimple marking: 
Sample Thigh Marking 
Sample Buttock Marking 

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NOTE: EN3835 is a foreign protein and Investigators must be prepared to address and manage 
an allergic reaction should it occur. At the time of each injection, a 1:1,000 solution of 
epinephrine for injection, 50-mg diphenhydramine injection or a suitable equivalent, and oxygen 
should be available and the Investigator and site staff must be familiar with their use.  
Care Procedures After Injection 
To evaluate the subject for possible immediate immunological AEs, the subject will remain in 
direct observation of medical personnel who are skilled in the management of an allergic 
reaction for 30 minutes after receiving the injection of study drug and until the subject exhibits 
no sign of an immunological or other clinically significant systemic or local AE. The subject’s 
vital signs should be stable before the subject can leave direct observation (see section 14.8).  
The Investigator or qualified designee will then apply a sterile dressing to the injection site with 
hypoallergenic tape. The subject will be instructed to remove the dressing in the evening.  
12.1.4.3. Treatment Session 2 (Treatment Visit 2/Day 22 ± 3 Days) and Treatment 
Session 3 (Treatment Visit 3/Day 43 ± 3 Days) 
Pre-injection 
1. Record concomitant medications/procedures (section 12.2) 
2. Body weight measurements  
3. Vital sign measurements (section 14.8)  
4. Collection of samples for urine pregnancy testing (section 14.7) 
5. Digital photograph of selected quadrant before dimple marking (section 13.1) 
6. Subject assessment of the severity of cellulite using photograph of the selected quadrant 
via PR-PCSS (section 13.1.1.1). NOTE: Complete the subject (PR-PCSS) assessment 
before the Investigator (CR-PCSS) assessment and before dimple marking. 
7. Investigator will conduct an independent live assessment of the severity of cellulite using 
the CR-PCSS (section 13.1.1.4). The investigator will conduct the assessment of severity 
only after the subject has completed her rating of her quadrant and without knowledge of 
the subject's rating of her quadrant. 
8. Selection and marking of dimples to be treated (section 12.1.4)  
9. Digital photograph after dimple marking (section 13.1)  
Injection 
Administration of study drug in the prone position (section 12.1.4.2) 
Post-injection 
1. Record number of dimples treated and number of injections administered 
2. Vital sign measurements (section 14.8) 

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3. Injection site reactions and local tolerability  
4. AEs (section 14) 
If the Investigator rates the selected quadrant as 0, no injections will be given. If no injections are 
given at treatment session 2, subjects will still return for the Day 43 visit and the selected 
quadrant will again be evaluated by the subject (PR-PCSS) and Investigator (CR-PCSS). If the 
Investigator rates the selected quadrant greater than 0 on the CR-PCSS, injections at treatment 
session 3 should be given. 
Because the goal of treatment is to improve the aesthetic appearance of the entire quadrant, the 
Investigator will be instructed to select dimples that in his or her opinion would most improve 
the aesthetic appearance of the entire quadrant. The same dimples within a quadrant or different 
dimples within a quadrant may be treated at each session but injections must all be within the 
selected quadrant for all 3 sessions. Each subject will receive all 3 treatment sessions unless the 
selected quadrant has no treatable EFP dimples and the Investigator rates the quadrant a score of 
0 on the CR-PCSS.  
After the dimples are selected, the Investigator or qualified designee will again mark each 
injection site with a “dot,” and circle each dimple (circles should not overlap).  
12.1.4.4. Day 71 (+5 Days) End of Treatment/Early Termination 
The following procedures will be performed on Day 71: 
1. Record concomitant medications/procedures (section 12.2) 
2. Measurement of body weight  
3. Vital sign measurements (section 14.8)  
4. Collection of samples for: 
a. Clinical laboratory testing (section 14.7) 
b. Anti-AUX-I and anti-AUX-II antibody testing (section 14.7.1)  
5. Digital photograph of selected quadrant (section 13.1)  
6. Subject cellulite assessments of the selected quadrant using the photographic image 
(NOTE: complete subject cellulite assessments before Investigator cellulite assessments) 
using: 
a. PR-PCSS assessment (section 13.1.1.1) 
b. S-GAIS (section 13.1.1.2) 
c. Subject satisfaction with cellulite treatment assessment (section 13.1.1.3) 
7. Investigator cellulite assessments of selected quadrant independently conducted; ie, with 
no knowledge of the subject's rating, using: 
a. CR-PCSS live assessment of subject (section 13.1.1.4) 
b. Hexsel CSS assessment of live subject while subject is standing in a relaxed position 
(section 13.1.1.6) 

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c. I-GAIS (section 13.1.1.5) 
8. Injection site reactions and local tolerability 
9. AEs (section 14) 
12.1.4.5. Follow-up Visits 
Following the Day 71 visit, the quadrant(s) treated with EN3835 in the open label study will be 
evaluated every 3 months from the first exposure to EN3835 following the schedule in Table 2. 
The first follow-up visit will be approximately 20 days after the Day 71 visit (ie approximately 
Day 90 after treatment session 1). 
12.2. 
Prior and Concomitant Medications and Procedures 
All medications (including over-the-counter medications) taken by the subject at screening 
visit 1 through the end of the study must be recorded. 
Additionally, any diagnostic, therapeutic or surgical procedures performed during the study 
period should be recorded including the date, indication for and description of the procedure.  
12.2.1. 
Prohibited Medications 
The following medications are prohibited for those subjects that elect to have treatment with 
study drug during the treatment phase of the study: anticoagulants (warfarin, heparin, direct 
thrombin inhibitors, Factor X inhibitors) and antiplatelet agents (aspirin >150 mg/day and P2Y12 
inhibitors, such as clopidogrel), which can cause additional bruising. However the use of aspirin 
DWDGRVHOHYHORIPJSHUGD\ZLOOEHSHUPLWWHGGXULQJWKHtreatment phase of the study. For 
those subjects in the observational-only phase of study, there are no prohibited medications. 
Table 5: 
Concomitant Medication Restrictions for Subjects During the Treatment 
Phase of Study 
Drug Class 
Restrictions 
Anticoagulants 
Subjects who elect treatment cannot take antiplatelet agents or 
DQWLFRDJXODQWVH[FHSWIRU mg aspirin daily) within 7 days before 
and after the dosing administration. 
12.2.2. 
Prohibited Procedures 
The treatments and procedures listed in exclusion criteria are prohibited during the study. 
12.3. 
Treatment Compliance 
All subjects who elect to have treatment will receive study drug administered by a clinician at the 
investigator’s site. 
Accidental or intentional overdoses should be reported to the Sponsor/designee promptly (see 
section 14.6.2). 

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12.4. 
Blinding and Randomization 
This study will be conducted as an open-label investigation; no blinding of assigned treatment 
will occur. 
12.5. 
End of Study 
At the time of study termination, ongoing subjects receiving treatment will be followed through 
the Day 71 visit. The remaining enrolled subjects will undergo early termination procedures in 
accordance with the Schedule of Events (section 5). 
 

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13. 
ASSESSMENT OF EFFICACY 
13.1. 
Primary Efficacy Measurements 
Although measures of efficacious drug effect (ie, durability of improvement) will be made 
during the observation phase before the study drug blind is broken in the double-blind study 
(EN3835-201), and thereafter to the end of study, emphasis is on the assessment of safety over 
12 months after exposure to EN3835. Cellulite severity assessments will be made at scheduled 
intervals for both observation-only subjects (not receiving EN3835) as well as subjects who 
choose re-dosing or re-treatment with EN3835. 
Digital Photography: Digital photography will be utilized to assess certain cellulite severity 
parameters at specific intervals (see Schedule of Events, Table 2) for subjects in the observation-
only group as well as those electing to be re-treated or re-dosed with EN3835. At the 
Screening B visit for subjects electing to receive re-dosing or re-treatment, the Investigator or 
qualified designee will photograph each quadrant using a Sponsor-supplied standardized digital 
camera. The subject will be standing for each photography session and will be wearing a 
standardized photographic garment as described in the Photography Manual. The Investigator or 
qualified designee will photograph the selected quadrant as follows: 
x Screening B (no dimple marking)  
x Before and after dimple marking (prior to injections) on Days 1, 22, and 43 of each 
treatment course 
x During the Day 71 visit (end of treatment phase/early termination) of each treatment 
course 
All photographs from this study are the property of Endo and may be utilized for clinical 
development, scientific communication, marketing, regulatory purposes, and/or legal 
applications as required/desired by Endo. 
13.1.1. 
Subject and Investigator Cellulite Assessments 
As in the double-blind parent study, Investigator cellulite assessments are independent of the 
subject assessments. Therefore, all subject cellulite assessments must be completed before the 
Investigator’s cellulite assessments are made. After both the subject’s and investigator’s 
assessments are completed, the subject’s assessments will be revealed and compared to the 
clinician’s assessments to determine eligible quadrants. If more than 1 quadrant is eligible, the 
subject will select one for treatment. 
13.1.1.1. Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) 
The PR-PCSS will be conducted for the purpose of assessing the severity of cellulite in the 
buttock or thigh; there are separate scales for buttocks or thighs. The scales are 5-level 
photonumeric scales developed specifically for patients and used by the subject to assess the 
severity of their cellulite in the quadrants by viewing digital images of each of their quadrants 
captured by photography at the visit; the ratings range from 0 (None) to 4 (Severe) with labels 
and descriptors to aid the subject in the assessments.  

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All subjects who enter the observation-only phase of the study will have the PR-PCSS evaluation 
at months 3, 6, 9, and 12. 
For subjects electing re-treatment or re-dosing after the study drug blind is broken in study 
EN3835-201, a Screening B visit (Baseline) within 14 days before dosing Day 1 will occur. 
Subjects will have digital photographs taken of all 4 quadrants as done in the double-blind trial 
for qualifying purposes. Subjects will then perform the PR-PCSS for both buttocks (Figure 1) 
and thighs (Figure 2) and will be reminded of their proper use (Appendix D).  
At the beginning of visits on Days 22, 43, and 71; digital photographs of the selected quadrant 
will be taken. If the buttock is the treated region, subjects will be given the PR-PCSS for the 
buttock to use to make their evaluation; if the thigh is the treated region, subjects will be given 
the PR-PCSS for the thigh to make their evaluation.  
 

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Figure 1: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the Buttock 
 

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Figure 2: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the Thigh 

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13.1.1.2. Subject Global Aesthetic Improvement Scale (S-GAIS) 
Subjects in the observation-only group will complete the S-GAIS as described below at the final 
study visit (month 12 or early termination) using the pre-treatment Day 1 image (Baseline) of the 
assigned quadrant in the double-blind study for comparison. 
For subjects who elected to receive EN3835 treatment, the S-GAIS assessment will be done on 
Day 71 of the treatment course and then at month 12 or the final study visit and compared back 
to the pre-dosing Screening B image (Baseline for treatment subjects) of the selected quadrant. 
All treated subjects will be instructed to answer the following question: How would you rate the 
appearance of your treated cellulite after treatment? 
The S-GAIS assessment will occur after the subject has completed the PR-PCSS assessment to 
avoid introducing potential bias to the static PR-PCSS assessment. Each subject will view the 
pre-dosing Screening B visit digital image alongside their Day 71 treatment course visit and 
month 12 or end of study visit digital image of their selected quadrant to aid in the assessment 
(Table 6). Subjects will circle the rating below that best represents their answer. 
Table 6: 
Subject Global Aesthetic Improvement Scale (S-GAIS) 
Rating 
Response Option 
Description 
+3 
Very much improved 
My treated cellulite looks very much better. 
+2 
Much improved 
My treated cellulite looks much better, but additional treatment 
would slightly improve the result. 
+1 
Improved 
My treated cellulite looks better, but additional treatment is 
necessary. 
0 
No change 
My treated cellulite looks essentially the same as it did 
originally. 
í1 
Worse 
My treated cellulite looks worse than it did originally. 
í2 
Much worse 
My treated cellulite looks much worse than it did originally. 
í3 
Very much worse 
My treated cellulite looks very much worse than it originally. 
13.1.1.3. Subject Satisfaction with Cellulite Treatment Assessment 
For observation-only subjects (not receiving EN3835) the subjects will assess their satisfaction 
with cellulite treatment at the 12 month or end of study visit by being instructed to answer the 
following question: Today, how satisfied are you with the results of the cellulite treatment you 
received on the specific area or areas on your buttocks or thighs that were treated? Subjects will 
circle the rating in the below table that best represents their answer. 
For subjects who have elected to receive EN3835 either through re-treatment or re-dosing, the 
subject satisfaction with the cellulite treatment (Table 7) with be done at the treatment course 
Day 71 and the month 12 visit or end of study visit. Subjects will be instructed to answer the 
following question: Today, how satisfied are you with the results of the cellulite treatment you 
received on the specific area or areas on your buttocks or thighs that were treated? Subjects will 
circle the rating below that best represents their answer. 

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Table 7: 
Subject Satisfaction with Cellulite Treatment Assessment 
Rating 
Description 
+2 
I am very satisfied with the cellulite treatment on my buttocks or thighs. 
+1 
I am satisfied with the cellulite treatment on my buttocks or thighs. 
0 
I am neither dissatisfied nor satisfied with the cellulite treatment on my buttocks or thighs. 
í1 
I am dissatisfied with the cellulite treatment on my buttocks or thighs. 
í2 
I am very dissatisfied with the cellulite treatment on my buttocks or thighs. 
13.1.1.4. Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 
The CR-PCSS will be conducted for the purpose of assessing the severity of cellulite in the 
buttock or thigh; there are separate scales for buttocks or thighs. The scales are 5-level 
photonumeric scales developed specifically for clinicians and used by the investigator to assess 
the severity of the subject’s cellulite in the quadrants by live assessments of the subject’s 
quadrant(s); the ratings range from 0 (None) to 4 (Severe) with labels and descriptors to aid the 
investigator in the assessments.  
Investigators will have been trained on the use of the CR-PCSS. For observation-only subjects, 
the CR-PCSS will be done at 3, 6, 9, and 12 months or at the end of study visit. 
For subjects who elected to receive EN3835 after the study drug blind is broken in study 
EN3835-201 as a re-treatment or re-dosing, the Investigator, at the Screening B visit (Baseline) 
will determine severity of cellulite of the 4 quadrants by assessing live subjects using the 
CR-PCSS for buttock (Figure 3) and thighs (Figure 4) after the subject has completed their self-
assessment using the PR-PCSS. The eligible quadrant chosen for injection will be at the 
discretion of the subject. Before injections on treatment visit Days 22 and 43 and on visit 
Day 71; Investigators will evaluate the selected quadrant by live assessments. If the buttock is 
the treated region, the Investigator will use the CR-PCSS for the buttock to make his/her 
evaluation; if the thigh is the treated region, the Investigator will use the CR-PCSS for the thigh 
to make his/her evaluation. In each case, the Investigator will make his/her assessment 
independently and after the subject has conducted their self-assessment using the PR-PCSS. 
This variable may be entered directly into the EDC system, thus the electronic database will 
serve as the direct point of data capture and will serve as source for this variable.  
 

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Figure 3: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for the Buttock 
 

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Figure 4: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for the Thigh 
 
 

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13.1.1.5. Investigator Global Aesthetic Improvement Scale (I-GAIS) 
Investigators will complete the I-GAIS on subjects in the observation-only group as described 
below at the final study visit (month 12 or early termination) and a comparison back to the pre-
treatment Day 1 (Baseline) image of the assigned quadrant of the double-blind study. 
On Day 71 of the treatment course and the 12 month or end of study visit, the Investigator will 
determine the degree of improvement from the Screening B digital image of the selected 
quadrant by comparing the cellulite in live assessment on Day 71 and at month 12 or study end 
to the Screening B pre-treatment (Baseline) image of the subject’s selected quadrant (Table 8). 
The I-GAIS assessment will occur after the CR-PCSS assessment (section 13.1.1.4) to avoid 
introducing potential bias to the static CR-PCSS assessment by the Investigator at the site.  
This variable may be entered directly into the EDC system, thus the electronic database will 
serve as the direct point of data capture and will serve as source for this variable.  
Table 8: 
Investigator Global Aesthetic Improvement Scale (I-GAIS) 
Rating 
Response Option 
Description 
+3 
Very much improved 
Optimal cosmetic result from treatment of the treated dimples 
+2 
Much improved 
Marked improvement in the treated area appearance from 
before treatment, but not completely optimal 
+1 
Improved 
Obvious improvement in the treated area appearance from 
before treatment, but additional treatment is indicated 
0 
No change 
The treated area appearance is essentially the same as before 
treatment 
í1 
Worse 
The treated area appearance is worse than before treatment 
í2 
Much worse 
Marked worsening in appearance from the initial condition 
í3 
Very much worse 
Obvious worsening in appearance from the initial condition 
13.1.1.6. Hexsel Cellulite Severity Scale 
The Hexsel Cellulite Severity Scale (referred to as the Hexsel CSS) is a photonumeric scale that 
looks at 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of 
depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or 
sagging of skin, and (E) current classification scale based on medical literature including 
Nürnberger and Müller.(12,13) Each of these features is evaluated on a 4-point scale from a low 
of 0 to a high of 3 as described in Table 9 (see Appendix B). The total score is the summation of 
all 5 features. 
For subjects in the observation-only group, the Hexsel CSS will be done at the month 12 or the 
end of study visit. 
For the subjects electing treatment (re-treatment or re-dosing) with EN3835 the Investigator or 
qualified designee will independently use the Hexsel CSS to assess the severity of EFP in all 
quadrants at Screening B visit and the selected quadrant on Day 71 of the course of treatment 
and at month 12 or end of study visit. All cellulite assessments should be made while the subject 
is in the standing position with relaxed gluteus muscles. However, when evaluating the subject 
for Category E (classification scale by Nürnberger and Müller) (13) if the subject has no evident 

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depressions, the subject should be asked to contract her gluteus muscles or the pinch test should 
be applied (by pinching the skin between the thumb and index finger) so the Investigator or 
qualified designee can differentiate between scores/grades of zero (0) or I. 
This variable may be entered directly into the EDC system, thus the electronic database will 
serve as the direct point of data capture and will serve as source for this variable.  
Table 9: 
Hexsel Cellulite Severity Scale 
A 
Number of evident depressions 
0=none/no depressions 
1=a small amount: 1-4 depressions are visible 
2=a moderate amount: 5-9 depressions are visible 
3=a large amount: 10 or more depressions are visible 
B 
Depth of depressions 
0=no depressions 
1=superficial depressions 
2=medium depth depressions 
3=deep depressions 
C 
Morphological appearance of skin 
surface alterations 
0=no raised areas 
1=‘orange peel’ appearance 
2=‘cottage cheese’ appearance 
3=‘mattress’ appearance 
D 
Grade of laxity, flaccidity, or sagging 
skin 
0=absence of laxity, flaccidity, or sagging skin 
1=slight draped appearance 
2=moderate draped appearance 
3=severe draped appearance 
E 
Classification scale by Nürnberger and 
Müllera 
0 = zero grade = Grade or Stage 0 = There is no alteration of the 
skin surface. 
1 = first grade = Grade or Stage I = The skin of the affected area 
is smooth while the subject is standing or lying, but the 
alterations to the skin surface can be seen by pinching the skin 
or with muscle contraction. 
2= second grade = Grade or Stage II = The orange skin or 
mattress appearance is evident when standing, without the use 
of any manipulation (skin pinching or muscle contraction). 
3= third grade = Grade or Stage III = The alterations described 
in Grade or Stage II, are present together with raised areas and 
nodules. 
Source: Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad 
Dermatol Venereol. 2009;23(5):523-528. 
a Subjects should be evaluated in the standing position with relaxed gluteus muscles. However, if the subject has no 
evident depressions, they should be asked to contract their gluteus muscles or the pinch test should be applied (by 
pinching the skin between the thumb and index finger) in order to differentiate between grade/stage of zero (0) 
or I. 
 

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14. 
ASSESSMENT OF SAFETY 
14.1. 
Definitions 
14.1.1. 
Adverse Event 
An adverse event (AE) is any unfavorable or unintended change in body structure (signs), body 
function (symptoms), laboratory result (eg, chemistry, ECG, X-ray, etc), or worsening of a pre-
existing condition associated temporally with the use of the study medication whether or not 
considered related to the study medication. AEs will be captured once a subject has signed the 
informed consent. AEs include: 
x Changes in the general condition of the subject 
x Subjective symptoms offered by or elicited from the subject 
x Objective signs observed by the Investigator or other study personnel 
x All concurrent diseases that occur after the start of the study, including any change in 
severity or frequency of pre-existing disease 
x All clinically relevant laboratory abnormalities or physical findings that occur during 
the study 
A treatment-emergent adverse event (TEAE) is any condition that was not present prior to 
treatment with study medication but appeared following treatment, was present at treatment 
initiation but worsened during treatment, or was present at treatment initiation but resolved and 
then reappeared while the individual was on treatment (regardless of the intensity of the AE 
when the treatment was initiated).  
All AEs, including both observed or volunteered problems, complaints, signs or symptoms must 
be recorded on the AE page of the eCRF, regardless of whether associated with the use of study 
medication. This would include AEs resulting from concurrent illness, reactions to concurrent 
medication use, or progression of disease states (excluding the disease under study). A condition 
present at baseline that worsens after initiation of study treatment will be captured as an AE; the 
onset date will be the date the event worsened. The AE should be recorded in standard medical 
terminology when possible. 
14.1.2. 
Serious Adverse Event 
A serious adverse event (SAE) is defined as an AE that: 
x Results in death 
x Is immediately life-threatening (there is an immediate risk of death from the AE as it 
occurred; this does not include an AE that had it occurred in a more serious form may 
have caused death) 
x Results in or prolongs an inpatient hospitalization (Note: a hospitalization for elective 
or pre-planned surgery, procedure, or drug therapy does not constitute an SAE)  

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x Results in permanent or substantial disability (permanent or substantial disruption of 
one’s ability to conduct normal life functions)  
x Is a congenital anomaly/birth defect (in offspring of a subject using the study 
medication regardless of time to diagnosis) 
x Is considered an important medical event 
Important medical events are defined as events that, based upon appropriate medical judgment, 
may jeopardize the subject and may require medical or surgical intervention to prevent one of the 
other serious outcomes. Examples of important medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions 
that do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse. 
14.2. 
Monitoring Adverse Events 
At each visit, subjects will be queried regarding any AEs that have occurred since the last visit. 
Subjects will be asked to volunteer information concerning AEs with a non-leading question 
such as, “How do you feel?” Study site personnel will then record all pertinent information in the 
source documents and the eCRF. The study drug compliance record should also be reviewed to 
detect potential overdoses (intentional/unintentional). 
14.3. 
Relationship to Study Drug 
The degree of “relatedness” of the AE to the study medication must be described using the 
following scale:  
x Not related indicates that the AE is definitely not related to the study medication. 
x Unlikely related indicates that there are other, more likely causes and study 
medication is not suspected as a cause. 
x Possibly related indicates that a direct cause and effect relationship between study 
medication and the AE has not been demonstrated, but there is evidence to suggest 
there is a reasonable possibility that the event was caused by the study medication. 
x Probably related indicates that there is evidence suggesting a direct cause and effect 
relationship between the AE and the study medication. 
It is the Sponsor’s policy to consider “Probably related” and “Possibly related” causality 
assessments as positive causality. “Not related” and “Unlikely related” causality assessments are 
considered as negative causality. 
Assessments will be recorded on the eCRF and must indicate clearly the relationship being 
assessed. For example, an AE that appears during a placebo run-in phase would be assessed with 
respect to the placebo treatment received and/or study procedures conducted during this phase. If 
the AE continued into an active treatment phase, the relationship would be assessed for the active 
treatment phase only if the AE worsened.  

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14.4. 
Intensity Assessment 
The intensity (or severity) of AEs is characterized as mild, moderate, or severe: 
x Mild AEs are usually transient, requiring no special treatment, and do not interfere 
with the subject’s daily activities. 
x Moderate AEs introduce a low level of inconvenience or concern to the subject and 
may interfere with daily activities, but are usually ameliorated by simple therapeutic 
measures. 
x Severe AEs interrupt a subject’s usual daily activity and typically require systemic 
drug therapy or other treatment. 
When the intensity category of an AE changes, the greatest intensity during that continuous 
episode should be recorded.  
14.5. 
Reporting Adverse Events and Serious Adverse Events 
14.5.1. 
Reporting Adverse Events 
Throughout the study, AEs will be documented on the source document and on the appropriate 
page of the eCRF whether or not considered treatment-related. This includes any new signs, 
symptoms, injury or illness, including increased severity of previously existing signs, symptoms, 
injury, or illness. Conditions existing prior to screening will be recorded as part of the subject’s 
medical history. The Investigator is responsible for assessing the relationship of AEs to the study 
medication; relationship will be classified as not related, unlikely related, possibly related, or 
probably related.  
All AEs will be collected by the Investigator from the time of signing the informed consent 
through 30 days after the last dose of study medication; this includes any AEs that are ongoing at 
the time of completion/termination of the study. All ongoing AEs must be followed until 
resolution or for 30 days after the subject’s last study visit, whichever comes first. 
14.5.2. 
Reporting Serious Adverse Events 
Any SAE, including death resulting from any cause, which occurs to any subject participating in 
this study must be reported via email or fax by the Investigator using the Endo Clinical Trial 
Report Form for SAEs within 24 hours of first becoming aware of the SAE. SAEs will be 
collected by the Investigator from the time of signing the informed consent through 30 days after 
the last dose of study medication. SAEs that occur within 30 days, following cessation of the 
study treatment, or within 30 days, following premature discontinuation from the study for any 
reason, must also be reported within the same timeframe. Any SAE that is considered by the 
Investigator to be related to the study medication must be reported regardless of the amount of 
time since the last dose received. Follow-up information collected for any initial report of an 
SAE must also be reported to the Sponsor within 24 hours of receipt by the Investigator.  
All SAEs will be followed until resolution, stabilization of condition, or until follow-up is no 
longer possible. 

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14.6.3. 
Pregnancy 
Any uncomplicated pregnancy that occurs in a subject during this clinical study will be reported 
for tracking purposes only. All subject pregnancies that are identified during or after this study, 
where the estimated date of conception is determined to have occurred during study drug therapy 
or within 30 days of the last dose of study medication need to be reported, followed to 
conclusion, and the outcome reported, even if the subject is discontinued from the study. The 
investigator should report all pregnancies within 24 hours using the Initial Pregnancy Report 
Form, and any pregnancy-associated SAE using the SAE report form, according to the usual 
timelines and directions for SAE reporting provided in section 14.5.2. Monitoring of the 
pregnancy should continue until conclusion of the pregnancy; 1 or more Follow-up Pregnancy 
Report Form(s) detailing progress, and a Two Month Follow-up Pregnancy Report Form 
detailing the outcome, should be submitted. 
Pregnancy itself is not regarded as an AE unless there is suspicion that the investigational 
product under study may have interfered with the effectiveness of a contraceptive medication. 
Likewise, elective abortions without complications are not considered AEs. Any SAEs 
associated with pregnancy (eg, congenital abnormalities/birth defects/spontaneous miscarriages 
or any other serious events) must additionally be reported as such using the SAE report form. 
Spontaneous miscarriages should also be reported and handled as SAEs.  
Subjects should be instructed to immediately notify the investigator of any pregnancies. 
Attempts to obtain the pregnancy follow-up and pregnancy outcome information detailed above 
are necessary even if a subject discontinues treatment because of pregnancy. 
14.6.4. 
Adverse Events/Serious Adverse Events Experienced by Non-subjects Exposed 
to Study Medication 
Non-subjects are persons who are not enrolled in the study but have been exposed to study 
medication, including instances of diversion of study medication. All such AEs/SAEs occurring 
in non-subjects from such exposure will be reported to the Endo Pharmacovigilance and Risk 
Management (PVRM) Department (when the non-subject agrees) on the departmental form for 
SAEs regardless of whether the event is serious or not. Instructions for completing the form for 
events experienced by non-subjects will be provided. SAEs occurring in non-subjects exposed to 
study medication will be processed within the same SAE reporting timelines as described in 
section 14.5.2, Serious Adverse Event Reporting. Additionally, the drug accountability source 
documentation at the site should reflect this occurrence. 
14.7. 
Clinical Laboratory and Immunogenicity Determinations 
Clinical laboratory tests will be conducted according to the Schedule of Events (section 5). 
Clinical laboratory tests will be performed by a designated central laboratory. Each site will be 
provided with instructions on specimen collection, preparation, packaging and transport. Refer to 
the central laboratory manual for further information regarding sample collection, handling, and 
labeling. The results of the tests will be returned to the investigational sites.  
Clinical laboratory test data will be reviewed by the investigator, or designee, and additional 
clinical laboratory tests may be ordered at his/her discretion (eg, if the results of any clinical 
laboratory test falls outside the reference range or clinical symptoms necessitate additional 

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testing to ensure safety). Any additional testing will be performed by the designated central 
laboratory. 
The investigator will review all abnormal lab results for clinical significance. Any abnormal 
clinical laboratory test result meeting the investigator’s or Sponsor’s criteria for clinical 
significance (refer to central laboratory manual) will be recorded as an AE or SAE as appropriate 
(see section 14.1.1, Adverse Events or section 14.1.2, Serious Adverse Events). 
Laboratory results will be sent electronically to Endo for data management. 
Clinical laboratory parameters that will be measured in this study are listed in Table 10. 
Table 10: 
Clinical Laboratory Parameters 
Hematology 
Clinical Chemistry 
Urinalysis 
Hematocrit 
Hemoglobin 
Red blood cell count 
Red blood cell morphology 
White blood cell count 
Neutrophils 
Lymphocytes 
Monocytes 
Basophils 
Eosinophils 
Platelets 
Blood urea nitrogen 
Creatinine 
Total bilirubin 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Alkaline phosphatase 
Sodium 
Potassium 
Calcium 
Chloride 
Phosphate 
Serum bicarbonate 
Uric acid 
Total cholesterol 
Total protein 
Glucose 
Triglycerides 
Albumin 
Specific gravity 
Ketones 
pH 
Protein 
Blood 
Glucose 
Female subjects of childbearing potential must have a negative urine pregnancy test at 
Screening B and at treatment visits 1, 2, and 3 (section 5) to receive treatment in the study. If 
necessary, additional urine pregnancy tests can be performed at any time during the study at the 
discretion of the Investigator.  
Results of the urine pregnancy test may be entered directly into the EDC system, thus the 
electronic database will serve as the direct point of data capture and will serve as source for this 
variable. 
14.7.1. 
Anti-AUX-I and Anti-AUX-II Antibodies 
Serum samples will be collected and may be tested for binding and neutralizing anti-AUX-I and 
anti-AUX-II antibodies at Visit 4 of the observation assessments. Additionally, if a subject 
consents to treatment in the open-label study, serum samples for antibody testing will be 
collected before injection at treatment visit 1 and at end of treatment/early termination visit 4 of 
the open-label treatment period. A subset of subject samples may have neutralizing antibodies 

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tested from Day 1 and Day 71 visits; additional samples may be analyzed if results or clinical 
signs warrant testing.  
The serum samples obtained will be processed, stored and then shipped on dry ice to the 
designated central clinical laboratory before forwarding to Endo’s appointed laboratory for the 
determination of anti-AUX-I and anti-AUX-II antibodies according to the Laboratory Manual. 
14.8. 
Vital Signs 
Vital sign measurements will be documented as described in the Schedule of Events. These 
parameters include pulse rate, respiratory rate, systolic and diastolic blood pressure, and body 
temperature. Pulse and blood pressure readings will be taken after the subject has been sitting for 
5 minutes. Height should only be recorded at Screening B.  
The investigator will review all vital sign values for clinical significance. Any vital sign value 
meeting the investigator’s or Sponsor’s criteria for clinical significance will be recorded as an 
AE or SAE as appropriate (see section 14.1.1, Adverse Events, and section 14.1.2, Serious 
Adverse Events). 
For subjects receiving treatment, vital signs will be assessed at the time points shown in Table 11 
after the subject has rested for at least 5 minutes.  
The subject’s vital signs should be stable, or repeated until stable before the subject can leave 
direct observation. 
This variable may be entered directly into the EDC system, thus the electronic database will 
serve as the direct point of data capture and will serve as source for this variable.  
Table 11: 
Vital Signs Measurements on Injection Day 
Time Point Relative to Last Injection 
Blood Pressure, Respiratory 
Rate, and Pulse Rate 
Body Temperature 
Up to 4 hours (before treatment) 
X 
X 
Approximately 15 minutes after 
X 
Approximately 30 minutes after 
X 
X 
14.9. 
Electrocardiogram 
Performing a 12-lead electrocardiogram (ECG) is not necessary if Screening B visit date is 
within 12 months of obtaining an ECG during the double-blind study (EN3835-201).  
If the date of Screening B visit is later than 12 months since obtaining the ECG in study 
EN3835-201, subjects will have a resting 12-lead ECG performed during the Screening B visit. 
A qualified physician will interpret, sign, and date the ECGs. Electrocardiogram assessments 
must be “within normal limits” or interpreted as “abnormal, not clinically significant” for the 
subject to be included in the study. 
Any ECG result meeting the investigator’s or Sponsor’s criteria for clinical significance will be 
recorded as an AE or SAE as appropriate (see section 14.1.1, Adverse Events and section 14.1.2, 
Serious Adverse Events). 

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The investigator’s assessment may be entered directly into the EDC system, thus the electronic 
database will serve as the direct point of data capture and will serve as source for this variable. 
14.10. 
Physical Examination 
Body weight will be collected as described in the Schedule of Events (section 5). If a subject 
desires treatment in the open-label study, a complete physical examination will be performed at 
Screening B. All examinations will be performed by a physician or health professional listed on 
the Form FDA 1572 and licensed to perform physical examinations. 
The investigator will review all physical exam findings for clinical significance. Any physical 
exam finding meeting the investigator’s or Sponsor’s criteria for clinical significance will be 
recorded as an AE or SAE as appropriate (see section 14.1.1, Adverse Events and section 14.1.2, 
Serious Adverse Events). 
This variable may be entered directly into the EDC system, thus the electronic database will 
serve as the direct point of data capture and will serve as source for this variable. 
14.11. 
Other Safety Assessments 
Not applicable. 

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15. 
ASSESSMENT OF PHARMACOKINETICS 
Not applicable. 

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16. 
ASSESSMENT OF PHARMACODYNAMICS 
Not applicable. 

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17. 
STATISTICAL CONSIDERATIONS AND METHODS 
17.1. 
Determination of Sample Size 
Approximately 350 subjects that completed the EN3835-201 study will enroll in the current 
study. This sample size should be adequate to determine long term safety and cellulite 
assessments of EN3835. 
17.2. 
Subject Cohorts and Subject Populations 
Subjects will be classified into 1 of 4 different cohorts depending on where they receive the 
treatment of EN3835 in relation to where they received treatment in study EN3835-201. The 
4 cohorts are: 
1. Observational subjects only - subjects who received EN3835 in study EN3835-201 but do 
not receive any injections in the current study. 
2. Re-treatment subjects - subjects who received EN3835 in study EN3835-201 and receive 
EN3835 in the current study in the same quadrant that was treated in the EN3835-201 
study. This will only be allowed for subjects who have baseline severity ratings in the 
current study at or worse than the baseline seen in study EN3835-201 for both the 
CR-PCSS and PR-PCSS of the quadrant.  
3. Re-dosing subjects - subjects who received EN3835 in study EN3835-201 and receive 
EN3835 in the current study in a quadrant different than the EN3835-treated quadrant in 
study EN3835-201. 
4. Initial treatment subjects - subjects who received placebo in study EN3835-201 and 
receive EN3835 in the current study. 
All efficacy and safety analyses will be done within the classified cohort. Durability of treatment 
effects is defined as the time from onset of change from baseline of PR-PCSS and CR-PCSS in 
the quadrant treated until the time that the treated quadrant returns to baseline cellulite severity 
ratings of PR-PCSS and CR-PCSS in an EN3835-treated quadrant. 
17.2.1. 
Observational Population 
The Observational population includes all subjects treated with EN3835 in study EN3835-201 
who do not receive any treatment in the current study. The durability of a treatment effect and 
long-term safety analyses for subjects who receive no treatment in the EN3835-201 study will be 
performed using this population. 
17.2.2. 
Safety Population 
The Safety population will include all subjects who receive at least 1 dose of EN3835 in the 
current study. All safety analyses will be performed using this population. 

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17.2.3. 
Effectiveness Population 
The Effectiveness population includes all safety subjects who have a baseline and at least 1 post-
baseline assessment on both the CR-PCSS and PR-PCSS on the quadrant selected for treatment 
in the current study. All analysis of effectiveness will be based on this population. 
17.3. 
Subject Disposition 
The number of subjects included in each study population will be summarized. The number and 
percentage of subjects completed and discontinued will be presented. Reasons for 
discontinuation as recorded on the eCRF will be summarized (number and percentage) for all 
subjects. 
17.4. 
Demographics and Other Baseline Characteristics 
Demographic and baseline characteristics, including age, race, and baseline values will be 
summarized for the Observational population, the Safety population, and the Effectiveness 
population using descriptive statistics. The descriptive statistics will include the number and 
percentage for categorical response variables and number, mean, standard deviation, minimum, 
and maximum for continuous variables. 
17.5. 
Efficacy Analyses 
Cellulite assessments (efficacy) include: 
x PR-PCSS: 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) (screening 
visit [Baseline], Days 22, 43, and 71). Also will be done at Day 90, Day 180, 
Day 270, and Day 360/end of study visits for observational assessments. 
x CR-PCSS: 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) (screening 
[Baseline], Days 22, 43, and 71). Also will be done at Day 90, Day 180, Day 270, and 
Day 360/end of study visits for observational assessments. 
x Investigator rating of cellulite severity using the total scores from the Hexsel CSS 
scale: scores can range from 0 to 15 (screening [Baseline] and Day 71). Also will be 
done at Day 360/end of study visits for observational assessments. 
x I-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) 
(Day 71). Also will be done at Day 360/end of study visit for observational 
assessments. 
x S-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much 
worse) (Day 71). Also will be done at Day 360/end of study visit for observational 
assessments. 
x Subject satisfaction with cellulite treatment assessment: 5-point scale ranging from 
+2 (very much satisfied) to í2 (very much dissatisfied) (Day 71). Also will be done at 
Day 360/end of study visit for observational assessments. 
All cellulite assessments will be done by treated quadrant. For initial treatment subjects who 
have 2 quadrants treated, each quadrant will be evaluated separately. 

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17.5.1. 
Efficacy Analysis 
The composite endpoints for cellulite severity are the proportions of composite responders 
defined as subjects with an improvement in severity from baseline of at least 2 (or 1) levels of 
severity in the CR-PCSS and an improvement in severity from baseline of at least 2 (or 1) levels 
of severity in the PR-PCSS. 
These endpoints, will be summarized by treated quadrant and overall (buttocks and thighs) and 
by study day using appropriate descriptive statistics. 
Other endpoints for treated quadrants include: 
x Proportion at each level of improvement in the PR-PCSS: 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels of severity in the PR-PCSS 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the PR-PCSS 
x Proportion at each level of improvement in the CR-PCSS: 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels of severity in the CR-PCSS (Investigator 
rated) 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the CR-PCSS (Investigator 
rated) 
x Proportion of responders at each level of the I-GAIS: 
 Proportion of Investigator global responders defined as subjects with a response 
of 1 (improved) or better in the Investigator GAIS assessment 
x Proportion of responders at each level of the S-GAIS: 
 Proportion of subject global responders defined as subjects with a response of 
1 (improved) or better in the subject GAIS assessment 
x Proportion of responders at each level of the subject satisfaction with cellulite 
treatment  
x Change in the Hexsel CSS total score from screening visit  
All endpoints will be summarized by treated region (buttock or thigh) and overall and by study 
day using appropriate descriptive statistics. 
Observational endpoints include: 
x Proportions of composite responders defined as subjects with an improvement in 
severity from baseline of at least 2 (or 1) levels of severity in the CR-PCSS and an 
improvement in severity from baseline of at least 2 (or 1) levels of severity in the 
PR-PCSS. 

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x
Proportion at each level of improvement in the PR-PCSS:

Proportion of patient responders defined as subjects with an improvement in
severity from baseline of at least 2 levels of severity in the PR-PCSS

Proportion of patient responders defined as subjects with an improvement in
severity from baseline of at least 1 level of severity in the PR-PCSS
x
Proportion at each level of improvement in the CR-PCSS:

Proportion of Investigator responders defined as subjects with an improvement in
severity from baseline of at least 2 levels of severity in the CR-PCSS (Investigator
rated)

Proportion of Investigator responders defined as subjects with an improvement in
severity from baseline of at least 1 level of severity in the CR-PCSS (Investigator
rated)
x
Hexsel CSS total score changed from the study EN3835-201 baseline at Day 71 of
study EN3835-201 and Day 360/end of study of the current study (EN3835-202).
These endpoints will be summarized by treated region (buttock or thigh) and overall and by 
study day using appropriate descriptive statistics. 
17.6. 
Safety Analyses 
The following variables are safety endpoints. 
x
AEs: Mapped to preferred term using the Medical Dictionary for Regulatory
Activities (MedDRA)
x
Injection site reactions/local tolerability in selected quadrant (through subject and
Investigator reporting)
x
Vital signs
x
Laboratory testing
AEs will be summarized by treatment group. AE duration will be summarized using descriptive 
statistics by treatment group. 
Descriptive statistics will be presented for each clinical laboratory test for the actual and change 
from screening at each visit by treatment group and vital signs for the actual and change from 
Day 1 pre-injection for each injection day at each visit by treatment group. 
17.6.1. 
Prior, Concomitant, and Follow-up Medication 
The World Health Organization (WHO) Drug Dictionary will be used to classify prior and 
concomitant medications by therapeutic class. The version used in this study will be stated in the 
Data Management Plan. Prior medication will be defined as any medication with a start date 
prior to the Day 1 date. Concomitant medication is defined as any medication with a start date on 
or after the Day 1 date or reported as ongoing. Any medications started after the last dose of 
study drug will be considered as follow-up medications. 

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Prior and concomitant medication use will be summarized descriptively by the number and 
percentage of subjects receiving each medication within each therapeutic class. Multiple use of 
the same medication by a subject will be counted only once. 
17.6.2. 
Study Drug Exposure 
For those subjects that elect, are eligible, and do receive treatment, the number of injections will 
be summarized by counts and percentages. The number of dimples treated will be summarized 
with counts and percentages.  
17.6.3. 
Measurement of Treatment Compliance 
All doses are administered while the subjects are at the investigational site. Any dose that was 
not administered per protocol will recorded as a protocol deviation by the Investigator. 
17.6.4. 
Adverse Events 
The MedDRA dictionary will be used to code AEs. The version used in this study will be stated 
in the Data Management Plan. 
Descriptive statistics (the number and percentage) for subjects reporting TEAEs will be tabulated 
by system organ class and preferred term; by system organ class, preferred term, and severity; 
and by system organ class, preferred term, and relationship to study drug. If more than 1 AE is 
coded to the same preferred term for the same subject, the subject will be counted only once for 
that preferred term using the most severe and most related occurrence for the summarization by 
severity and by relationship to the study drug. 
SAEs and AEs leading to premature discontinuation of study drug will be summarized. Listings 
will be presented for subjects with SAEs, subjects with AEs leading to discontinuation, and 
subjects who die (if any). 
17.6.5. 
Vital Signs 
Descriptive statistics for vital signs (eg, systolic and diastolic blood pressure, pulse rate, 
respiratory rate, temperature, and body weight) and their changes from baseline at each visit and 
at the end of treatment visit will be presented.  
Vital sign values are potentially clinically significant (PCS) if they meet both the observed value 
criteria and the change from baseline criteria. The criteria for PCS vital sign values will be 
detailed in the Statistical Analysis Plan (SAP). A listing of all AEs for subjects with PCS vital 
signs will also be provided. 
17.6.6. 
Clinical Laboratory Parameters 
Descriptive statistics for clinical laboratory values in International System of Units (SI units) and 
changes from baseline will be presented for each clinical laboratory parameter. 
The number and percentage of subjects with PCS post-baseline clinical laboratory values will be 
tabulated. The criteria for PCS laboratory values will be detailed in the SAP. A listing of all AEs 
for subjects with PCS laboratory values will also be provided. 

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17.7. 
Immunogenicity Analyses 
Immunogenicity variables include anti-AUX-I/anti-AUX-II binding antibody results. Binding 
antibody levels will be determined from samples collected on Days 1 and 71 during the treatment 
phase and Day 360 during the observational phase. 
Descriptive statistics (percent of positive measurements and average antibody level) will be 
presented for anti-AUX-I and anti-AUX-II antibody levels at each time point by region treated 
and overall. Average antibody levels will be summarized on logarithmically transposed titer 
values. 
17.8. 
Pharmacokinetic Analyses 
Not applicable. 
17.9. 
Interim Analysis 
Not applicable. 
17.10. 
Statistical Software 
Statistical analyses will be performed using Version 9.3 (or higher) of SAS® (SAS Institute, 
Cary, North Carolina). 

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18.5.1. 
Study Drug Handling and Disposal 
The Investigator is responsible for recording the receipt and use of all drug supplied and for 
ensuring the supervision of the storage and allocation of these supplies. All unused study drug 
will be returned, and unit counts will be performed whenever medication is returned. The site 
must account for all study drug received. The Investigator agrees not to supply study drug to any 
person except to those subjects enrolled in the study. At the end of the study, all unused drug 
supplies will be returned to Endo as instructed by the clinical monitor. 

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19. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
19.1. 
Source Documents 
Source documents include but are not limited to original documents, data and records such as 
hospital/medical records (including electronic health records), clinic charts, lab results, subject 
diaries, data recorded in automated instruments, microfilm or magnetic media, and pharmacy 
records, etc. This study allows for direct data entry (DDE) for selected data points as outlined 
below: 
x Inclusion/exclusion 
x Vital signs including pre- and post-injection measurements 
x Height and body weight 
x CR-PCSS 
x Hexsel CSS 
x I-GAIS 
x Physical examinations 
x ECG results (if more than 1 year passed since ECG assessment) 
x Urine pregnancy test 
x Study drug administration 
All other data points, at a minimum, should have supporting source documentation for entries in 
the eCRF. 
19.2. 
Study Monitoring 
A representative of Endo Pharmaceuticals Inc. will meet with the Investigator and his/her staff 
prior to the entrance of the first subject to review study procedures and methods of recording 
findings in the eCRF.  
After enrollment of the first subject, an Endo Pharmaceuticals Inc. representative will be 
assigned to periodically monitor each Investigator site for study progress and to verify that 
standards of Good Clinical Practice (GCP) were followed. The Investigator is expected to 
prepare for the monitor visit, ensuring that all source documents, completed eCRFs, signed 
consent forms, and other study related documents are readily available for review. 
19.3. 
Audits and Inspections 
The Investigator shall permit audits and inspections by the Sponsor, its representatives and 
members of regulatory agencies. The investigator should immediately notify the Sponsor of an 
upcoming FDA or other regulatory agency inspection. 

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19.4. 
Institutional Review Board (IRB) 
The Investigator shall permit members of the IRB/IEC to have direct access to source 
documents. 
19.5. 
Data Recording and Documentation 
All data recordings and source documentation (including electronic health records) must be made 
available to the Sponsor (or designee), FDA and any other regulatory agencies that request 
access to study records, including source documents, for inspection and copying, in keeping with 
federal and local regulations. 

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20. 
QUALITY CONTROL AND QUALITY ASSURANCE 
Steps to assure the accuracy and reliability of data include the selection of qualified principal 
investigators and appropriate study centers, review of protocol procedures with the principal 
investigators and associated personnel prior to start of the study, and periodic monitoring visits 
conducted by the Sponsor or Sponsor representative. Significant and/or repeated non-compliance 
will be investigated and remedial action instituted when appropriate. Failure to comply with 
remedial actions may result in investigator site termination and regulatory authority notification. 
The Sponsor or its designee will utilize qualified monitors to review and evaluate activities 
conducted at Investigator Sites. 
The data will be entered into the clinical study database and verified for accuracy, following 
procedures defined by the Sponsor (or designee). Data will be processed and analyzed following 
procedures defined by the Sponsor (or designee). 
The study will be monitored and/or audited at intervals to ensure that the clinical study is 
conducted and data are generated, documented (recorded), and reported in compliance with the 
Study Protocol; International Conference on Harmonisation (ICH), E6 consolidated guidelines; 
and other applicable regulations. The extent, nature, and frequency of monitoring and/or audits 
will be based on such considerations as the study objectives and/or endpoints, the purpose of the 
study, study design complexity, and enrollment rate. At the conclusion of a program, a 
compliance statement will be generated by the Sponsor (or designee) listing all audit activities 
performed during the clinical study. 

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21. 
ETHICS 
21.1. 
Ethics Review 
Approval by the IRB/IEC prior to the start of the study will be the responsibility of the 
Investigator. A copy of approval documentation will be supplied to Endo Pharmaceuticals Inc. 
along with a roster of IRB members that demonstrates appropriate composition (a Department of 
Health and Human Services [DHHS] Assurance Number will satisfy this requirement).  
The study protocol, the informed consent form, advertisements, materials being provided to 
subjects and amendments (if any) will be approved to IRB/IECs at each study center in 
conformance with ICH E6, the Code of Federal Regulations (CFR), Title 21, Part 56 and any 
other applicable local laws. The Investigator is responsible for supplying the IRB/IEC with a 
copy of the current IB, Package Insert, or SPC as well as any updates issued during the study. 
During the course of the study, the Investigator will provide timely and accurate reports to the 
IRB/IEC on the progress of the study, at intervals not exceeding 1 year (or as appropriate), and 
will notify the IRB/IEC of SAEs or other significant safety findings, per the policy of the 
IRB/IEC. At the conclusion of the study, the Investigator will submit a final report or close out 
report to the IRB/IEC and provide a copy to Endo Pharmaceuticals Inc. 
Any amendment to this protocol will be provided to the Investigator in writing by Endo 
Pharmaceuticals Inc. No protocol amendment may be implemented (with the exceptions noted 
below) before it has been approved by the IRB and the signature page, signed by the 
Investigator, has been received by Endo Pharmaceuticals Inc. Where the protocol is amended to 
eliminate or reduce the risk to the subject, the amendment may be implemented before IRB 
review and approval. However, the IRB must be informed in writing of such an amendment and 
approval obtained within reasonable time limits. Deviating from the protocol is permitted only if 
absolutely necessary for the safety or clinical management of the subject, and must be 
immediately reported to Endo Pharmaceuticals Inc.  
The Investigator will be responsible for supplying updated safety and/or study information to 
study subjects as it becomes available. 
21.2. 
Ethical Conduct of the Study 
This clinical study is designed to comply with the ICH Guidance on General Considerations for 
Clinical Trials (62 FR 6611, December 17, 1997), Nonclinical Safety Studies for the Conduct of 
Human Clinical Trials for Pharmaceuticals (62 FR 62922, November 25, 1997), Good Clinical 
Practice: Consolidated Guidance (62 FR 25692, May 9, 1997) and 21 CFR parts 50, 54, 56, and 
312. 
The study will be conducted in full compliance with ICH E6, the FDA guidelines for GCP and in 
accordance with the ethical principles that have their origins in the Declaration of Helsinki 
defined in 21 CFR, 312.120. 

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21.3. 
Subject Information and Consent 
Subjects, after having the study explained to them and an opportunity to have their questions 
answered sufficiently, will give voluntary and written informed consent (in compliance with ICH 
E6, 4.8 and 21 CFR Parts 50 and 312) before participating in any study-related procedures. The 
consent shall be written in a language understandable to the subject. Subjects unable to read 
(illiterate) shall have the consent process performed in the presence of an independent witness 
who shall also sign the consent. Each subject will read, assent understanding, and sign an 
instrument of informed consent after having had an opportunity to discuss the study and consent 
documents with the Investigator before signing, and will be made aware that she may withdraw 
from the study at any time.  
In addition to obtaining informed consent, the Investigator is responsible for obtaining any 
additional documentation to demonstrate compliance with local privacy laws applicable to 
activities performed.  
The consent process shall be recorded in source documents. Signed copies of the informed 
consent will be given to the Subject and originals will be placed in the Investigator study files.  
A unique Subject identification number will be assigned according to section 12.1.3 at the time 
that the Subject signs the informed consent form. 
 

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22. 
DATA HANDLING AND RECORDINGKEEPING 
22.1. 
Data Collection 
Data collection will involve the use of an EDC system to which only authorized personnel will 
have access. The system will be secured to prevent unauthorized access to the data or the system. 
This will include the requirement for a user ID and password to enter or change data. The level 
of access to the EDC system will be dependent on the person’s role in the study. 
Study data will be collected by DDE or from source documents and entered into an eCRF within 
the EDC system. The Investigator will be responsible for ensuring the eCRFs are completed in a 
timely manner relative to the subject’s visit. In addition to periodic monitoring occurring within 
the system by a Sponsor monitor, programmatic edit checks will be used to review EDC data for 
completeness, logic, and adherence to the study protocol. As a result of this monitoring and these 
checks, queries may be issued electronically to the clinical study sites and closed electronically 
by the monitor, data management staff or authorized staff at the study site. Additionally, the 
Investigator will review eCRFs, ensure all missing or corrected data is provided and will sign the 
eCRF pages with an electronic signature.  
An electronic audit trail will be maintained in the EDC system to track all changes made to data 
entered in the eCRF. Data will be retrievable in such a fashion that all information regarding 
each individual subject is attributable to that subject. 
In addition, any contact with the subject via telephone or other means that provide significant 
clinical information must be documented in source documents as described above. 
22.2. 
Study Documentation 
Upon study completion, the Investigator will be provided with complete electronic copies of the 
eCRF data for his/her files.  
 

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23. 
REPORTING AND PUBLICATION 
All data generated in this study are the property of Endo. An integrated clinical and statistical 
report will be prepared at the completion of the study. 
Publication of the results by the Investigator will be subject to mutual agreement between the 
Investigator and Endo. 

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24. 
INVESTIGATOR OBLIGATIONS 
24.1. 
Regulatory Documents 
The Investigator is responsible for creating and/or maintaining all study documentation required 
by 21CFR 50, 54, 56 and 312, ICH, E6 section 8, as well as any other documentation defined in 
the protocol or the Investigator Agreement. The Investigator must maintain the documentation 
relating to this study and permit Endo Pharmaceuticals Inc. or a member of a regulatory agency 
access to such records. 
The Investigator must provide the following key documents to Endo Pharmaceuticals Inc. prior 
to the start of the study: 
x A completed and signed Form FDA1572. If during the course of the study any 
information reported on the Form FDA 1572 changes, a revised Form FDA1572 must 
be completed and returned to Endo Pharmaceuticals Inc. for submission to the FDA. 
For studies executed outside the United States, documentation required by the 
governing regulatory authority may be substituted for the Form FDA 1572. 
x A fully executed contract 
x The Investigator’s Statement page in this protocol signed and dated by the 
Investigator and any subsequent amendment signature pages 
x The IB acknowledgment of receipt page 
x Curricula vitae for the Principal Investigator and all Sub-Investigators listed on Form 
FDA 1572, including a copy of each physician’s license (if applicable) 
x A copy of the original IRB/IEC approval for conducting the study. If the study is 
ongoing, renewals must be submitted at yearly intervals or shorter intervals defined 
by the IRB/IEC. All subsequent modifications must be submitted and approved by the 
IRB, as described in section 21.1  
x A copy of the IRB/IEC-approved informed consent form 
x A list of IRB/IEC members or DHHS Assurance Number 
x Laboratory certifications and normal ranges (if local labs are required by the protocol) 
x A financial disclosure agreement completed and signed by the Investigator and all 
Sub-Investigators listed on Form FDA 1572. Investigator site staff that submitted an 
initial financial disclosure are also responsible for informing Endo Pharmaceuticals 
Inc. of any changes to their initial financial disclosure form 1 year after the 
completion of the study. 
A complete list of required regulatory documents will be supplied by Endo Pharmaceuticals Inc. 
or its representative. 

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24.2. 
Delegation of Responsibilities and Adequate Resources 
The Investigator should have adequate time to conduct the study properly and should have an 
adequate number of qualified staff to assist with the conduct of the study. The Investigator shall 
delegate tasks only to individuals qualified by education, training and experience to perform the 
delegated tasks. The Investigator shall have direct oversight of all delegated activities and shall 
document delegation of responsibilities. The Investigator is responsible for ensuring all delegated 
staff have been properly trained on the protocol and their assigned study responsibilities. 
24.3. 
Medical Care of Study Subjects 
The Investigator and/or a qualified sub-investigator shall be responsible for the subjects’ medical 
care. Any unrelated medical condition discovered during the course of the study should be 
communicated to the subject so that they may seek appropriate medical care. The Investigator 
will report all AEs as required by the protocol (section 14.5). The Investigator will inform study 
subjects of new information regarding the study drug as it becomes available. 
24.4. 
Use of Investigational Materials 
The Investigator will acknowledge that the study drug supplies are investigational and as such 
must be used strictly in accordance with the protocol and only under the supervision of the 
Principal Investigator or Sub-Investigators listed on Form FDA1572 (or other regulatory 
document, depending on region). Study drug must be stored in a safe and secure location. At 
study initiation, a representative from Endo Pharmaceuticals Inc. will inventory the study drug at 
the site. The Investigator must maintain adequate records documenting the receipt and 
disposition of all study supplies. Endo Pharmaceuticals Inc. or its representative will supply 
forms to document total inventory as well as subject specific accountability. The Investigator is 
responsible for monitoring use of the study drug to ensure compliance with the protocol. All 
study supplies shall be returned to Endo Pharmaceuticals Inc. or its designee.  
24.5. 
Retention of Records 
Federal and local regulations require that the Investigator retain a copy of all regulatory 
documents and records that support the data for this study (eg, informed consents, laboratory 
reports, source documents, study drug dispensing records) for whichever of the following is the 
longest period of time: 
x A period of 2 years following the final date of approval by the FDA or other 
regulatory agency of the study drug for the purposes that were the subject of the 
investigation; or 
x A period of 5 years following the date on which the results of the investigation were 
submitted to the FDA or other regulatory agency in support of, or as part of, an 
application for a research or marketing permit for the study drug for the purposes that 
were the subject of the investigation 
Endo will notify Investigators once one of the above 2 timeframes has been satisfied. 
If the investigation does not result in the submission of the data in support of, or as part of, an 
application for a research or marketing permit, records must be retained for a period of 2 years 

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following notification by Endo Pharmaceuticals Inc. that the entire clinical investigation (not 
merely the Investigator’s portion) is completed, terminated, or discontinued or 2 years following 
withdrawal of the Investigational New Drug application (IND).  
If the Investigator retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the study records, custody must be transferred to a person who will accept the 
responsibility. Endo must be notified in writing of the name and address of the new custodian. 
Study records should not be destroyed without consultation with Endo Pharmaceuticals Inc. 
24.6. 
Subject Confidentiality 
All subject records submitted to Endo Pharmaceuticals Inc. or its designee will be identified only 
by initials and subject identification number. Subjects’ names are not to be transmitted to Endo 
Pharmaceuticals Inc. The Investigator will keep a Master Subject List on which the identification 
number and the full name, address, and telephone number of each subject are listed. It is the 
Investigators’ responsibility to inform study subjects that representatives of the Sponsor, FDA, or 
other regulatory agencies may review all records that support their participation in the study. The 
Investigator will adhere to all privacy laws to which he/she is subject. 
 

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25. 
TERMINATION OF STUDY 
The Sponsor has the right to suspend or terminate the study at any time. The study may be 
suspended or terminated for any reason. 

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26. 
INVESTIGATOR’S AGREEMENT 
I agree to conduct the study in accordance with the protocol, and with all applicable government 
regulations and Good Clinical Practice guidance. 
 
 
 
 
_____/_____/______ 
Investigator’s Signature 
Date 
 
 
 
Typed Name of Investigator 
 

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27. 
REFERENCES 
1. Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part I. Pathophysiology. 
J Am Acad Dermatol 2010;62(3):361-370. 
2. Hexsel D, de Oliveira Dal’Forno T, Mazzuco R. Definition, clinical aspects, 
classifications, and diagnostic techniques. In: Goldman MP, Hexsel D, eds. Cellulite: 
Pathophysiology and Treatment. 2nd ed. New York, NY: Informa Healthcare; 
2010:13-21. 
3. Rawlings AV. Cellulite and its treatment. Int J Cosmetic Sci. 2006;28(3):175-190. 
4. Terranova F, Berardesca E, Maibach H. Cellulite: nature and aetiopathogenesis. Int J 
Cosmetic Sci. 2006;28(3):157-167. 
5. Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther. 
2004;6(4):181-185. 
6. Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part II. Advances and 
controversies. J Am Acad Dermatol 2010;62(3):373-384. 
7. Collis N, Elliot LA, Sharpe C, Sharpe DT. Cellulite treatment: a myth or reality: a 
prospective randomized, controlled trial of two therapies, endermologie and 
aminophylline cream. Plast Reconstr Surg. 1999;104(4):1110-1114. 
8. Hexsel DM, Mazzuco R. Subcision: a treatment for cellulite. Int J Dermatol. 
2000;39(7):539-544. 
9. Boyce S, Pabby A, Chuchaltkaren P, Brazzini B, Goldman MP. Clinical evaluation of a 
device for the treatment of cellulite: Triactive. Am J Cosmet Surg. 2005;22:233-237. 
10. DiBernardo BE. Treatment of celllulite using a 1440-nm pulsed laser with one-year 
follow-up. Aesthet Surg J. 2011;31(3):328-341. 
11. Dagum AB, Badalamente MA. Collagenase injection in the treatment of cellulite. Plas 
Reconst Surg. 2006;118(suppl 4):53. 
12. Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity scale. 
J Eur Acad Dermatol Venereol. 2009;23(5):523-528. 
13. Nürnberger F, Müller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 
1978;4(3):221-229. 
 

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LIST OF APPENDICES 
Appendix A  Documents Required Prior to Initiation of the Study 
Appendix B  Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity 
scale. J Eur Acad Dermatol Venereol. 2009;23(5):523-528. 
Appendix C  Reference Images for Hexsel Severity Ratings 
Appendix D 
Patient Instructions for Use of the PR-PCSS 

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APPENDIX A. DOCUMENTS REQUIRED PRIOR TO INITIATION OF 
THE STUDY 
As a Sponsor of a clinical study, Endo Pharmaceuticals Inc. has an obligation to ensure that the 
study will be conducted by a qualified Investigator with sufficient resources of time, personnel, 
and physical facilities to conduct the study and to ensure that the Investigator understands and 
agrees to comply with the protocol, applicable regulations, policies, and procedures. The 
following documentation is required: 
From the Principal Investigator 
1. A signed agreement to perform the study per protocol (the signature page will suffice). 
2. A signed Letter of Financial Agreement (including confidentiality statement). 
3. Name(s) of the Principal Investigator and of all sub-Investigator(s) 
4. All address(es) of the clinical site(s). 
5. A current medical license valid where he/she practices and a current curriculum vitae for 
the Principal Investigator (signed and dated) and all sub-investigators, to contain at least 
the following elements: 
a. For physicians: 
i. Date of degree in Medicine 
ii. Name of the Institution granting the degree in Medicine. 
iii. Previous clinical postings with dates. 
b. For non-physician allowed by national law or regulations to act as clinical 
Investigators: 
i. Date and description of most advanced degree. 
ii. Name of the Institution granting the degree in number (i). 
iii. Other accreditation or qualifications relevant to the study. 
iv. Previous postings with dates. 
v. Name and qualification (see 5a above) of the physician or dentist in charge of 
study subjects. 
Note: If a non-physician is serving as Principal Investigator, then a qualified physician 
must be assigned as a sub-Investigator for the trial, to be responsible for all trial-related 
medical decisions. 
6. Written notification of Institutional Review Board/Independent Ethics Committee/Human 
Research Ethics Committee (IRB/IEC/HREC) approval. The minimum requirements are 
as follows: 
a. Dated letter, including: 
i. The date on which the meeting for the review of the study protocol took place. 
ii. Study protocol/amendment number, and version date 

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iii. A clear statement of approval of the protocol and the informed consent text with 
version date, and authorization for the study to proceed. 
iv. If the Investigator or any sub-Investigator is a part of the IRB/IEC/HREC 
Review Board, assurance that the Investigator abstained from voting at the 
meeting(s) when the study was discussed.  
b. A dated list of the members and their occupations. 
c. A specimen copy of the Committee-approved informed consent text to be used in the 
study. 
7. Food and Drug Administration (FDA) Form 1572 (for studies submitted under a US 
Investigational New Drug application [IND]). 
8. Financial Disclosure Certification or Certification of Non-Disclosure (for studies to be 
submitted for a US New Drug Application/Biologics License Application [NDA/BLA]). 
Other 
Any other documentation required by national law or regulations to be in the possession of the 
Sponsor or the Investigator for study participation or study initiation. 
 

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APPENDIX B. HEXSEL DM, DAL’FORNO T, HEXSEL CL. A 
VALIDATED PHOTONUMERIC CELLULITE SEVERITY 
SCALE. J EUR ACAD DERMATOL VENEREOL. 
2009;23(5):523-528. 
 

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APPENDIX D. PATIENT INSTRUCTIONS FOR USE OF PATIENT-
REPORTED PHOTONUMERIC CELLULITE SEVERITY 
SCALE (PR-PCSS) 
 

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EN3835-202 Protocol Amendment 2 
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Section 
Original Text 
Revised Text 
4 Synopsis, 
Objectives, 
Secondary 
To evaluate the durability of response to 
EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects 
previously receiving active treatment in study 
EN3835-201 using the Patient-Reported 
Photonumeric Cellulite Severity Scale 
(PR-PCSS), the Clinician-Reported 
Photonumeric Cellulite Severity Scale 
(CR-PCSS), and the Hexsel Cellulite Severity 
Scale (CSS) 
To evaluate long-term response to EN3835 in 
assessments of EFP including subject 
satisfaction, Investigator Global Aesthetic 
Improvement Scale (I-GAIS), and Subject 
Global Aesthetic Improvement Scale (S-
GAIS) 
To evaluate immunogenicity after exposure to 
EN3835 
To assess safety and immunogenicity of re-
treating or re-dosing a subject that had 
previously received treatment with EN3835 
To evaluate the durability of response to 
EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects 
previously receiving active treatment in study 
EN3835-201 using the Patient-Reported 
Photonumeric Cellulite Severity Scale 
(PR-PCSS) and the Clinician-Reported 
Photonumeric Cellulite Severity Scale 
(CR-PCSS) 
To evaluate long-term response to EN3835 in 
assessments of EFP including subject 
satisfaction, Investigator Global Aesthetic 
Improvement Scale (I-GAIS), and Subject 
Global Aesthetic Improvement Scale 
(S-GAIS) 
To assess cellulite severity assessments in 
quadrants treated in this study with EN3835. 
To evaluate immunogenicity after exposure to 
EN3835 
4 Synopsis, 
Study Design 
Treatments will be administered on days 1, 
22, and 43; subjects will be assessed for safety 
on days 1, 22, 43, and 71 and for cellulite 
severity assessments on days 1, 43, and 71.  
Treatments will be administered on Days 1, 
22, and 43; subjects will be assessed for safety 
on Days 1, 22, 43, and 71 and for cellulite 
severity assessments at Screening visit and on 
Days 22, 43, and 71.  
4 Synopsis, 
Diagnosis and 
inclusion/ 
exclusion criteria 
Qualification for the Open-Label 
Treatment Phase of the Study 
Inclusion criteria for treatment: 
Have participated in and completed the 
double-blind study EN3835-201 and all day 
71 assessments 
Qualification for the Open-Label 
Treatment Phase of the Study 
Inclusion criteria for treatment: 
Have participated in and completed the 
double-blind study EN3835-201  
4 Synopsis, 
Duration of 
Study 
Follow-up: For subjects treated with EN3835 
in this study, subjects will be observed at 
treatment visits (Days 1, 22, and 43) and Day 
71 after first injection. 
Follow-up: For subjects treated with EN3835 
in this study, subjects will be observed at 
treatment visits (Days 1, 22, and 43) and Day 
71 after first injection. After Day 71, they will 
be observed every 3 months from their first 
exposure to EN3835 up to a maximum of 1 
year. 
5 Schedule of 
Events 
NOTE: Observation visits (Table 2) in the 
open-label extension study begin after 
completion of double-blind study (day 71). 
Treatment sessions (Table 3), if elected, will 
begin when study drug blind is broken in 
study EN3835-201 while observation visits 
continue concurrently. 
NOTE: Observation visits (Table 2) in the 
open-label extension study begin after 
completion of double-blind study (Day 71). 
Treatment sessions (Table 3), if elected, will 
begin after study drug blind is broken in study 
EN3835-201while observation visits continue 
concurrently. 

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Section 
Original Text 
Revised Text 
Table 2 
Observation 
Assessments, 
Collection of 
Samples: Anti-
AUX-I/anti-
AUX-II antibody 
level 
Visit 1: X 
Visit 2: X 
Visit 3: X 
Visit 4: X 
Visit 1:  
Visit 2:  
Visit 3:  
Visit 4: X 
Table 3 
Treatment 
Session 
Assessments, 
Column Heading 
Tx Visit 4 
End of Treatment/  
Early Termination 
Day 71 (±5 days)b 
Tx Visit 4 
End of Treatment/  
Early Termination 
Day 71 (+5 days)b 
Table 3 
Treatment 
Session 
Assessments, 
Procedures  
Screening Ba: 
Medical history/EFP history including 
previous treatments: Xk 
Prior/Concomitant Medications/Procedures: 
Xk 
Physical examination: 
Body weight: X 
Height: X 
Collection of samples: 
Clinical laboratory X 
Tx Visit 1: 
Prior/Concomitant Medications/Procedures: X 
Screening Ba: 
Medical history/EFP history including 
previous treatments: Xk,m 
Prior/Concomitant Medications/Procedures: 
Xk,m 
Physical examination: 
Body weight: Xm 
Height: Xm 
Collection of samples: 
Clinical laboratory: Xm 
Tx Visit 1: 
Prior/Concomitant Medications/Procedures: 
Xm 
Table 3 
Treatment 
Session 
Assessments, 
Collection of 
Samples: Anti-
AUX-I/anti-
AUX-II antibody 
level 
Tx Visit 1: Xe 
Tx Visit 2: Xe 
Tx Visit 3: Xe 
Tx Visit 4: X  
Tx Visit 1: Xe,m 
Tx Visit 2:  
Tx Visit 3:  
Tx Visit 4: X 
Table 3 
Treatment 
Session 
Assessments, 
footnotes 
a Eligible subjects may choose additional 
treatment any time after the study drug blind 
is broken in study EN3835-201. 
Add 
a After the study drug blind is broken in study 
EN3835-201, eligible subjects may elect to 
receive EN3835 treatments. 
m Do not conduct on subjects eligible and 
opting-in for a second course of treatment in 
the current study (EN3835-202) if Screening 
B visit or Day 1 visit for second treatment 
course is the same day as Day 71 of the first 
treatment course in this study or previous 
study EN3835-201. 

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Section 
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Revised Text 
9.2 Secondary 
Objectives 
To assess safety and immunogenicity of 
re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
To evaluate the durability of response to 
EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects 
previously receiving active-treatment in study 
EN3835-201 using the PR-PCSS, the 
CR-PCSS, and the Hexsel CSS 
To evaluate long-term response to EN3835 in 
assessments of EFP including subject 
satisfaction, I-GAIS, and S-GAIS 
To assess cellulite severity assessments in 
quadrants treated in this study with EN3835 
To assess safety and immunogenicity of 
re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
To evaluate the durability of response to 
EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects 
previously receiving active-treatment in study 
EN3835-201 using the PR-PCSS and the 
CR-PCSS 
To evaluate long-term response to EN3835 in 
assessments of EFP including subject 
satisfaction, I-GAIS, and S-GAIS 
To assess cellulite severity assessments in 
quadrants treated in this study with EN3835 
To evaluate immunogenicity after exposure to 
EN3835 
10.1 Study 
Design 
Following the study drug blind being broken 
and communicated to centers, treatments of 
eligible subjects with EN3835 can begin at a 
visit at the discretion of the subject. 
Following the study drug blind being broken 
and communicated to centers, eligible subjects 
may elect to receive EN3835 treatment.  
11.1 Observation 
Phase  
All subjects who have completed the double-
blind study EN3835-201, including all day 71 
assessments, and sign informed consent are 
eligible for enrollment in this open-label 
extension study and participation in the 
ongoing safety and cellulite evaluations.  
All subjects who have completed the double-
blind study EN3835-201 and sign the 
informed consent are eligible for enrollment in 
this open-label extension study and 
participation in the ongoing safety and 
cellulite evaluations.  
11.2.1 Subject 
Inclusion Criteria 
for Treatment 
Have participated in and completed the 
double-blind study EN3835-201 and all Day 
71 assessments 
Have participated in and completed the 
double-blind study EN3835-201  
11.2.2 Subject 
Exclusion 
Criteria for 
Treatment 
Add 
Presence of any clinically relevant conditions, 
that in the opinion of the Investigator would 
interfere with completing the study including, 
but not limited to, visual problems, hearing 
problems, cognitive impairment or acute 
mental illness 
12.1.3 Study 
Entry/ 
Observational 
Assessments 
A subject who gives written informed consent 
and who satisfies all eligibility criteria 
(section 11) may be entered into the 
observational phase of the study and complete 
safety and cellulite severity assessments at 
3-month intervals as detailed in Table 2. 
A subject who gives written informed consent 
and who satisfies all eligibility criteria 
(section 11) may be entered into the 
observational phase of the study and complete 
safety and cellulite severity assessments at 
3-month intervals as detailed in Table 2. The 
first visit will be determined by the date of 
enrollment in study EN3835-202 relative to 
the Schedule of Events for Study EN3835-202 
(Table 2). For example, if a subject enrolls 
after the Day 90 visit window, the first 
observation visit for that subject would be 
Day 180. 

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Section 
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Revised Text 
12.1.4 Treatment 
Assessments 
(Optional)  
If a subject received placebo in the double-
blind study, she may be eligible for 2 
treatments in the open-label study; if a subject 
received active drug in the double-blind study, 
she may be eligible for 1 additional treatment 
(3 treatment sessions) in the open-label study.  
If a subject received placebo in the double-
blind study, she may be eligible for 2 
treatment courses in the open-label study; if a 
subject received active drug in the 
double-blind study, she may be eligible for 1 
additional treatment course (3 treatment 
sessions) in the open-label study.  
12.1.4 Treatment 
Assessments 
(Optional), 
Selection of 
Treatment 
Quadrant 
The Investigator will then assess each of the 4 
subject’s quadrants live in real-time using the 
CR-PCSS.  
The Investigator will then assess each of the 
subject’s 4 quadrants live in real-time using 
the CR-PCSS.  
12.1.4 Treatment 
Assessments 
(Optional), 
Selection of 
Treatment 
Quadrant 
A subject who received placebo in the double-
blind study may be treated in the same 
quadrant in the open-label study if the 
quadrant still meets all 3 criteria OR another 
qualifying quadrant may be selected for 
treatment by the Investigator and subject.  
A subject who received placebo in the double-
blind study may be treated in the same 
quadrant in the open-label study if the 
quadrant still meets all 3 criteria OR another 
qualifying quadrant may be selected for 
treatment by the subject.  
12.1.4 Treatment 
Assessments 
(Optional), 
Selecting and 
Marking 
Dimples 
The cellulite severity assessments using the 
PR-PCSS, CR-PCSS, and Hexsel CSS will be 
completed prior to dimple marking at 
treatment visits 2, 3, and 4/end of treatment. 
The cellulite severity assessments using the 
PR-PCSS and CR-PCSS will be completed 
prior to dimple marking at treatment visits 2, 
3, and 4/end of treatment. 
12.1.4.1 
Screening B 
'D\VíWRí
Relative to 
Open-Label 
Treatment Visit 
Day 1)  
The Investigator will conduct live assessments 
of subject’s cellulite severity of each quadrant 
using the CR-PCSS (section 13.1.1.4) 
The Investigator will conduct independent live 
assessments of subject’s cellulite severity of 
each quadrant using the CR-PCSS 
(section 13.1.1.4) after the subject completes 
her ratings and with no knowledge of the 
subject's ratings of her quadrants. 
12.1.4.1 
Screening B 
'D\VíWRí
Relative to 
Open-Label 
Treatment Visit 
Day 1) 
Collection of samples for: 
Clinical laboratory testing including 
Anti-AUX-I and anti-AUX-II antibody testing 
(section 14.7) 
Urine pregnancy testing (section 14.7) 
Collection of samples for: 
Clinical laboratory testing (section 14.7) 
Urine pregnancy testing (section 14.7) 
12.1.4.2, 
Subheading 
Treatment Session 1 (Visit 1B) 
Treatment Session 1 (Treatment Visit 1) 
12.1.4.2 
Treatment 
Session 1 
(Treatment Visit 
1), Pre-injection 
5. Collection of samples for urine pregnancy 
testing (section 14.7) 
Collection of samples for:  
anti-AUX-I and anti-AUX-II antibody testing 
(section 14.7.1) 
urine pregnancy testing (section 14.7) 
12.1.4.3, 
Subheading 
Treatment Session 2 (Visit 2/Day 22 ± 
3 Days) and Treatment Session 3 
(Visit 3/Day 43 ± 3 Days) 
Treatment Session 2 (Treatment Visit 2/ 
Day 22 ± 3 Days) and Treatment Session 3 
(Treatment Visit 3/Day 43 ± 3 Days) 

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Section 
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Revised Text 
12.1.4.3  
Pre-injection 
Investigator live assessment of the severity of 
cellulite using the CR-PCSS (section 13.1.1.4) 
Investigator will conduct an independent live 
assessment of the severity of cellulite using 
the CR-PCSS (section 13.1.1.4). The 
investigator will conduct the assessment of 
severity only after the subject has completed 
her rating of her quadrant and without 
knowledge of the subject's rating of her 
quadrant. 
12.1.4.3  
If no injections are given at treatment session 
2, subjects will still return for the day 43 visit 
and the selected quadrant will again be 
evaluated by the subject (PR-PCSS) and 
Investigator (CR-PCSS). 
If the Investigator rates the selected quadrant 
as 0, no injections will be given. If no 
injections are given at treatment session 2, 
subjects will still return for the Day 43 visit 
and the selected quadrant will again be 
evaluated by the subject (PR-PCSS) and 
Investigator (CR-PCSS). 
12.1.4.4 Day 71 
(+5 Days) End of 
Treatment/Early 
Termination, 
Subheading 
Day 71 (±5 Days) End of Treatment/Early 
Termination 
Day 71 (+5 Days) End of Treatment/Early 
Termination 
12.1.4.4 Day 71 
(+5 Days) End of 
Treatment/Early 
Termination 
Investigator cellulite assessments of selected 
quadrant using: 
Investigator cellulite assessments of selected 
quadrant independently conducted; ie, with no 
knowledge of the subject's rating, using: 
13.1.1.2 Subject 
Global Aesthetic 
Improvement 
Scale (S-GAIS)  
The S-GAIS assessment will be done on day 
71 of the treatment course and then at month 
12 or the final study visit and compared back 
to the pre-dosing Screening B image (Baseline 
for treatment subjects) of the selected 
quadrant. 
For subjects who elected to receive EN3835 
treatment, the S-GAIS assessment will be 
done on Day 71 of the treatment course and 
then at month 12 or the final study visit and 
compared back to the pre-dosing Screening B 
image (Baseline for treatment subjects) of the 
selected quadrant. 
13.1.1.6 Hexsel 
Cellulite Severity 
Scale  
For subjects in the observation-only group, the 
Hexsel CSS will be done at month 3 and every 
3 months thereafter and at the month 12 or the 
end of study visit. 
For subjects who elected to have EN3835 
treatments, the Hexsel CSS will be done at 
3-month intervals during the observation 
phase until the study drug blind is broken in 
study EN3835-201. The Hexsel CSS 
assessment will be done at Screening B visit 
and on day 71 of the treatment course and at 
month 12 or end of study visit. 
For the subjects electing treatment 
(re-treatment or re-dosing) with EN3835 the 
Investigator or qualified designee will use the 
Hexsel CSS to assess the severity of EFP in 
all quadrants at Screening B and the selected 
quadrant on day 71 of the course of treatment. 
For subjects in the observation-only group, the 
Hexsel CSS will be done at the month 12 or 
the end of study visit. 
For the subjects electing treatment 
(re-treatment or re-dosing) with EN3835 the 
Investigator or qualified designee will 
independently use the Hexsel CSS to assess 
the severity of EFP in all quadrants at 
Screening B visit and the selected quadrant on 
Day 71 of the course of treatment and at 
month 12 or end of study visit. 

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Section 
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Revised Text 
24.4 Use of 
Investigational 
Materials  
The Investigator is responsible for monitoring 
subject’s use of the study drug to ensure 
compliance with the protocol. All study 
supplies shall be returned to Endo 
Pharmaceuticals Inc. or its designee (this may 
include empty packaging such as bottles and 
blister cards). It is the Investigator’s 
responsibility to ensure that subjects return 
their medication. 
The Investigator is responsible for monitoring 
use of the study drug to ensure compliance 
with the protocol. All study supplies shall be 
returned to Endo Pharmaceuticals Inc. or its 
designee.  
18.2 Study Drug 
Packaging and 
Labeling  
Sterile vials of lyophilized EN3835 (formerly 
4500) and sterile diluent will be provided to 
the Investigator by Endo. Each kit will contain 
1 vial each of EN3835 and sterile diluent. 
Sterile vials of lyophilized EN3835 and sterile 
diluent will be provided to the Investigator by 
Endo. Each kit will contain 2 vials each of 
EN3835 and sterile diluent. 
18.4 Study Drug 
Preparation  
Designated study personnel will visually 
inspect the study drug vial to determine the 
integrity and acceptability of the lyophilized 
drug product for reconstitution. 
Designated study personnel will visually 
inspect the study drug vials to determine the 
integrity and acceptability of the lyophilized 
drug product for reconstitution. 
24.6 Subject 
Confidentiality  
All subject records submitted to Endo 
Pharmaceuticals Inc. or its designee will be 
identified only by initials and code number. 
All subject records submitted to Endo 
Pharmaceuticals Inc. or its designee will be 
identified only by initials and subject 
identification number. 
24.6 Subject 
Confidentiality  
The Investigator will adhere to all privacy 
laws to which she is subject. 
The Investigator will adhere to all privacy 
laws to which he/she is subject. 
 

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4. 
SYNOPSIS 
Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Title of Study: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous 
Fibrosclerotic Panniculopathy 
Lead Principal Investigator: To be determined 
Study period:  
Estimated date first subject enrolled: Oct-2016 
Estimated date last subject completed: Sep-2017 
Phase of development: Phase 2 
Objectives:  
Primary: 
x 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at 
scheduled intervals over 1 year (12 months) in all subjects with edematous fibrosclerotic 
panniculopathy (EFP) who elect to enroll in this open-label trial regardless of their decision to 
receive treatment (re-treatment or re-dosing) of open-label EN3835 or opt to receive no 
treatment.  
Secondary: 
x 
To evaluate safety and immunogenicity of re-treating or re-dosing a subject that had previously 
received treatment with EN3835 
x 
To evaluate the durability of response to EN3835 in EFP severity over the 12-month post initial 
dosing of EN3835 in subjects previously receiving active treatment in study EN3835-201 using 
the Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) and the Clinician-
Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 
x 
To evaluate long-term response to EN3835 in assessments of EFP including subject satisfaction, 
Investigator Global Aesthetic Improvement Scale (I-GAIS), and Subject Global Aesthetic 
Improvement Scale (S-GAIS) 
x 
To assess cellulite severity assessments in quadrants treated in this study with EN3835. 
x 
To evaluate immunogenicity after exposure to EN3835 
Study Design: This study is a Phase 2 open-label study for the safety and efficacy of EN3835 in the 
treatment of EFP. To be eligible, a subject must have participated and completed the previous cellulite 
study EN3835-201. Subjects will be screened for study eligibility within 14 days prior to enrolling in 
this study (EN3835-202). Subjects will be assessed for safety and cellulite severity assessments 
approximately every 3 months for a maximum of 1 year from their first exposure to EN3835. Subjects 
with at least 1 quadrant with moderate or severe level of cellulite will be eligible for treatment with 
EN3835 after unblinding of study EN3835-201; a quadrant that was treated with EN3835 in the previous 
study EN3835-201 will only be eligible for retreatment if the cellulite severity in that quadrant is rated at 
levels of cellulite severity at baseline in study EN3835-201. 
A treatment course will consist of 3 treatment sessions separated by 21 days. Treatment will be allowed 
in eligible subjects up to a maximum of 2 treatment courses including the treatment course in study 
EN3835-201 if subject was treated with EN3835. Each treatment session will consist of up to 
12 injections (0.07 mg/0.3 mL per injection) of EN3835 for a dose of 0.84 mg and volume of 3.6 mL. 
Only a quadrant with moderate (rating of 3) or severe (rating 4) level of severity as assessed by the 

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Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
subject and investigator using the PR-PCSS and the CR-PCSS, respectively, will be eligible for 
treatment; if more than 1 eligible quadrant exists, the quadrant selected will be at the discretion of the 
subject. Treatments will be administered on Days 1, 22, and 43; subjects will be assessed for safety on 
Days 1, 22, 43, and 71 and for cellulite severity assessments at Screening visit and on Days 22, 43, and 
71. After Day 71, they will be observed every 3 months from their first exposure to EN3835 up to a 
maximum of 1 year. The study will terminate when at least 100 subjects have been assessed at 
12 months after the first exposure to EN3835. 
Number of subjects (planned): 333 
Study center(s): 16 sites in the United States  
Diagnosis and inclusion/exclusion criteria: 
Qualification for the Open-Label Observation Phase of the Study 
Inclusion criteria for observation:  
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be willing to apply sunscreen to any treated quadrant before each exposure to the sun while 
participating in the study (ie, screening through end of study) 
Exclusion criteria for observation: 
None 
Qualification for the Open-Label Treatment Phase of the Study 
Inclusion criteria for treatment: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. %HDIHPDOH\HDUVRIage 
4. At Screening B visit, have at least 1 quadrant with: 
a. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 
b. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and 
c. a Hexsel Cellulite Severity Scale (CSS) score no greater than 13 
5. Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun 
while participating in the study (ie, Screening B through end of study) 
6. Be judged to be in good health, based upon the results of a medical history, physical 
examination, and laboratory profile at Screening B 
7. Have a negative urine pregnancy test at Screening B and before injection of study drug and be 
using an effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal 
[estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle 
prior to study enrollment and for the duration of the study; or be menopausal defined as 
12 months of amenorrhea in the absence of other biological or physiological causes, as 
determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile 
8. Be willing and able to cooperate with the requirements of the study 
9. Be able to read, complete and understand the patient-reported outcomes rating instruments in 
English 

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Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Exclusion criteria for treatment: 
1. Has used any of the following for the treatment of EFP on the legs or buttock within the 
timelines identified below or intends to use any of the following at any time during the course of 
the study: 
x 
Liposuction on the side of the body selected for treatment during the 12-month period 
before injection of study drug 
x 
Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery 
(including subcision and/or powered subcision) within the selected treatment quadrant 
during the 12-month period before injection of study drug 
x 
Endermologie or similar treatments within the selected treatment quadrant during the 
6-month period before injection of study drug 
x 
Massage therapy within the selected treatment quadrant during the 3-month period before 
injection of study drug 
x 
Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected 
treatment quadrant during the 2-week period before injection of study drug 
2. Is presently nursing a baby or providing breast milk for a baby 
3. Intends to become pregnant during the study 
4. Has received an investigational drug or treatment within 30 days before injection of study drug 
5. Has a known systemic allergy to collagenase or any other excipient of study drug 
6. Is currently receiving or plans to receive anticoagulant or antiplatelet medication or has received 
antLFRDJXODQWRUDQWLSODWHOHWPHGLFDWLRQH[FHSWIRUPJDVSLULQGDLO\ZLWKLQGD\VEHIRUH
injection of study drug 
7. Has a known recent history of stroke, bleeding, or other medical condition, which in the 
investigator’s opinion would make the subject unsuitable for enrollment in this phase of the 
study 
8. Presence of any clinically relevant conditions, that in the opinion of the Investigator would 
interfere with completing the study including, but not limited to, visual problems, hearing 
problems, cognitive impairment or acute mental illness 
Investigational product, dosage and mode of administration: EN3835, 0.84 mg, subcutaneous. A 
dose of 0.84 mg of EN3835 will be administered as up to 12 subcutaneous injections (0.3-mL injection 
administered as three 0.1-mL aliquots per injection, up to 12 injections per treatment session) for a 
maximum volume of 3.6 mL per treatment session. A treatment course will consist of 3 treatment 
sessions at 21 days intervals, ie, treatments on Days 1, 22, and 43 of each treatment course. 
For the observational periods of this study, subjects will be assessed for safety and cellulite severity 
assessments at approximately 3-month intervals for a maximum of 1 year following their first exposure 
to EN3835. 
Duration of study: Twelve (12) months from first exposure to EN3835 in study EN3835-201 or study 
EN3835-202 
Screening Phase: Up to 14 days 
Observational Phase: Subjects will be assessed at visits that occur approximately every 3 months for a 
maximum of 1 year after the first exposure to EN3835. 

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Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Follow-up: Subjects will be assessed at visits that occur approximately every 3 months for a maximum 
of 1 year after the first exposure to EN3835. For subjects treated with EN3835 in this study, subjects 
will be observed at treatment visits (Days 1, 22, and 43) and Day 71 after first injection. After Day 71, 
they will be observed every 3 months from their first exposure to EN3835 up to a maximum of 1 year. 
Reference therapy, dosage and mode of administration: Not applicable 
Criteria for evaluation: 
Efficacy: 
x 
PR-PCSS while viewing digital images of the selected quadrant: 5-point scale ranging from 
0 (no cellulite) to 4 (severe cellulite) (approximately every 3 months after initial injection [either 
an injection in previous study EN3835-201 or after an injection in this study]). If treatment is 
administered in this study, PR-PCSS will be obtained at Screening B (Baseline), Days 22, 43, 
and 71 after initial treatment within this study. 
x 
Investigator using the CR-PCSS by live assessment: 5-point scale ranging from 0 (no cellulite) 
to 4 (severe cellulite) (every 3 months after initial injection [either an injection in previous study 
EN3835-201 or after an injection in this study]). If treatment is administered in this study, 
CR-PCSS will be obtained at Screening B (Baseline), Days 22, 43, and 71 after initial treatment 
within this study. 
x 
Investigator rating of cellulite severity using the total score from the Hexsel CSS: scores can 
range from 0 (no cellulite) to 15 (extremely severe cellulite) (Day 360). If treatment is 
administered in this study, Hexsel CSS will be obtained in this study at Screening B (Baseline) 
and Day 71 after initial treatment within this study. 
x 
I-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) (Day 71) 
x 
S-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) (Day 71) 
x 
Subject satisfaction with cellulite treatment assessment: 5-point scale ranging from 2 (very 
satisfied) to í2 (very dissatisfied) (Day 71) 
Safety:  
Safety will be assessed throughout the study through the recording of: 
x 
Adverse events (AEs) 
x 
Vital signs 
x 
Clinical laboratory tests 
x 
Immunogenicity assessment (ie, assessed through the determination of binding and neutralizing 
anti-AUX-I and anti-AUX-II antibody levels). 
In addition, for subjects treated with EN3835 in this study, injection site reactions/local tolerability in 
treated quadrant (through subject and Investigator reporting) will be assessed. 
Statistical methods: 
Sample Size Consideration:  
The number of subjects (approximately 333) is intended to obtain additional subjects for adequate long-
term safety data at the selected dose. 
Analysis Populations:  
Observational population: The Observational population is defined as all subjects treated with EN3835 
in study EN3835-201 who do not receive any treatment in the current study 

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Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Safety population: The Safety population is defined as all enrolled subjects who received at least 
1 injection of EN3835 in this study or in study EN38335-201. 
Intent-to-Treat (ITT) population: The ITT population is defined as all enrolled subjects in this study. 
Modified Intent-to-Treat (mITT) population: The mITT population is defined as ITT subjects who 
received at least 1 injection of EN3835 in this study with a baseline and 1 post-injection evaluation of 
both the CR-PCSS and PR-PCSS. All efficacy (cellulite assessments) analyses will be completed on this 
population. 
Per-Protocol population: The Per-Protocol population is defined as those subjects in the Safety 
population who have no major protocol deviations.  
Efficacy Evaluations: 
The primary cellulite severity assessment endpoint, the proportion of composite responders with 
improvement of 2 or better on each scale (CR-PCSS and PR-PCSS) at Day 71, will be summarized as 
percentages and analyzed using a Cochran-Mantel-Haenszel test that compares the 2 treatment groups 
and adjusts for Investigator. The ITT population will be evaluated for the primary endpoint with any 
subjects not having a post-injection evaluation of either CR-PCSS or PR-PCSS classified as a 
non-responder. 
All secondary endpoints, except the Hexsel CSS total score, will be summarized as percentages. The 
dichotomous secondary endpoints (ie, responders endpoints) will be analyzed using a Cochran-Mantel-
Haenszel test adjusted for investigator. Multiple-response endpoints (ie, scales) will be analyzed using 
the Mann-Whitney test. Change in Hexsel CSS total score will be summarized with descriptive statistics 
for continuous variable and will be analyzed using analysis of variance (ANOVA). 
Safety Analysis:  
The following variables are safety endpoints: 
x 
AEs: Mapped to preferred term using the Medical Dictionary for Regulatory Activities 
(MedDRA) 
x 
Vital signs 
x 
Clinical laboratory tests 
AEs will be summarized by proportion of subjects reporting each event. Descriptive statistics will be 
presented for actual and change from baseline at each visit for vital signs and for each clinical laboratory 
test parameter. 
Immunogenicity: Anti-AUX-I and anti-AUX-II antibody levels will be summarized using descriptive 
statistics for the actual value at the visit. 
 

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5. 
SCHEDULE OF EVENTS 
NOTE: Observation visits (Table 2) in the open-label extension study begin after completion of 
double-blind study (Day 71). Treatment sessions (Table 3), if elected, will begin after study drug 
blind is broken in study EN3835-201while observation visits continue concurrently. 
 

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a After the study drug blind is broken in study EN3835-201, eligible subjects may elect to receive EN3835 treatments. 
b Upon completion of treatment, subject will be followed at 3-month intervals as in Table 2; if study terminates early, subject will be followed through Visit 4 
(Day 71). If subject received placebo in the double-blind study (EN3835-201), she may be eligible for a total of 2 courses of treatment (a total of 6 treatment 
sessions) in this study. 
c All 4 quadrants are photographed at screening; at other visits, the selected quadrant only is photographed. 
d Before and after marking the dimples. 
e Before injection. 
f Up to 4 hours before injection; approximately 15 and 30 minutes after injection. Vital signs must be stable before the subject is discharged. 
g Assessment made via photograph (if treatment session, use photograph taken before marking dimples). 
h All 4 quadrants are assessed at the Screening B visit; at other visits, the selected quadrant only is assessed. 
i Initial Hexsel CSS at sFUHHQLQJPXVWEHRQselected quadrant (Appendix C). 
j To qualify for treatment, the selected quadrant must have a score of 3 or 4 (moderate or severe) in both the CR-PCSS and PR-PCSS, and a Hexsel CSS score 
; to qualify a quadrant that had been previously treated with EN3835 in study EN3835-201, the quadrant must have CR-PCSS and PR-PCSS scores equal to 
or greater than study EN3835-EDVHOLQHVFRUHVDQGD+H[VHO&66VFRUH13. 
k Medical history and prior medications will be based on EN3835-201 eCRF; only updates and concomitant medications need to be captured at Screening B visit. 
l Do not conduct if Screening B visit date is within 12 months of obtaining an ECG during the double-blind study (EN3835-201). 
m Do not conduct on subjects eligible and opting-in for a second course of treatment in the current study (EN3835-202) if Screening B visit or Day 1 visit for 
second treatment course is the same day as Day 71 of the first treatment course in this study or previous study EN3835-201. 
ECG=Electrocardiogram; eCRF=Electronic case report form; EFP=Edematous fibrosclerotic panniculopathy; Tx=Treatment 
NOTE: Subject cellulite assessments must be completed before the Investigator cellulite assessments are conducted at each visit. 
 

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6. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES 
TABLE OF CONTENTS 
1. 
TITLE PAGE ................................................................................................................1 
2. 
SUMMARY OF CHANGES ........................................................................................2 
3. 
SPONSOR CONTACT INFORMATION .................................................................10 
4. 
SYNOPSIS .................................................................................................................11 
5. 
SCHEDULE OF EVENTS .........................................................................................16 
6. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ...............20 
7. 
LIST OF ABBREVIATIONS.....................................................................................26 
8. 
INTRODUCTION ......................................................................................................28 
8.1. 
Edematous Fibrosclerotic Panniculopathy .................................................................28 
8.2. 
Current Edematous Fibrosclerotic Panniculopathy Treatments .................................28 
8.3. 
EN3835 (Collagenase Clostridium Histolyticum) ......................................................30 
8.3.1. 
Studies with EN3835 for the Treatment of Edematous Fibrosclerotic 
Panniculopathy ...........................................................................................................30 
8.3.1.1. 
Investigator-Initiated Proof-of-Concept Study ...........................................................30 
8.3.1.2. 
Endo-Sponsored Phase 1b Dose-Escalation Study AUX-CC-830 .............................31 
8.3.1.3. 
Endo-Sponsored Phase 2a Dose-Ranging Study AUX-CC-831 ................................31 
8.3.1.4. 
Endo-Sponsored Phase 2b Study EN3835-201 ..........................................................31 
8.4. 
Summary of Nonclinical Studies ................................................................................32 
8.5. 
Summary of Known Risks and Benefits .....................................................................32 
8.6. 
Rationale .....................................................................................................................32 
9. 
OBJECTIVES .............................................................................................................33 
9.1. 
Primary Objective .......................................................................................................33 
9.2. 
Secondary Objectives .................................................................................................33 
9.3. 
Exploratory Objectives ...............................................................................................33 
10. 
INVESTIGATIONAL PLAN .....................................................................................34 
10.1. 
Study Design ...............................................................................................................34 
10.2. 
Selection of Doses ......................................................................................................36 
10.3. 
Study Drug Administration.........................................................................................36 
10.4. 
Discussion of Study Design, Including the Choice of Control Groups ......................36 

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11. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................37 
11.1. 
Observation Phase ......................................................................................................37 
11.1.1. 
Subject Inclusion Criteria for Observation .................................................................37 
11.1.2. 
Subject Exclusion Criteria for Observation ................................................................37 
11.2. 
Treatment ....................................................................................................................37 
11.2.1. 
Subject Inclusion Criteria for Treatment ....................................................................37 
11.2.2. 
Subject Exclusion Criteria for Treatment ...................................................................38 
11.3. 
Subject Discontinuation Criteria .................................................................................39 
11.3.1. 
Replacement Procedures .............................................................................................39 
12. 
PROCEDURES AND TREATMENTS .....................................................................40 
12.1. 
Study Visits .................................................................................................................40 
12.1.1. 
Subject Screening .......................................................................................................40 
12.1.2. 
Screening Assessments ...............................................................................................40 
12.1.3. 
Study Entry/Observational Assessments ....................................................................40 
12.1.3.1. 
Three-Month Assessments..........................................................................................40 
12.1.4. 
Treatment Assessments (Optional) .............................................................................41 
12.1.4.1. 
6FUHHQLQJ%'D\VíWRí5HODWLYHWR2SHQ-Label Treatment Visit Day 1) .........42 
12.1.4.2. 
Treatment Session 1 (Treatment Visit 1) ....................................................................43 
12.1.4.3. 
Treatment Session 2 (Treatment Visit 2/Day 22 ± 3 Days) and Treatment 
Session 3 (Treatment Visit 3/Day 43 ± 3 Days) .........................................................46 
12.1.4.4. 
Day 71 (+5 Days) End of Treatment/Early Termination ............................................47 
12.1.4.5. 
Follow-up Visits .........................................................................................................48 
12.2. 
Prior and Concomitant Medications and Procedures ..................................................48 
12.2.1. 
Prohibited Medications ...............................................................................................48 
12.2.2. 
Prohibited Procedures .................................................................................................48 
12.3. 
Treatment Compliance ................................................................................................48 
12.4. 
Blinding and Randomization ......................................................................................49 
12.5. 
End of Study ...............................................................................................................49 
13. 
ASSESSMENT OF EFFICACY ................................................................................50 
13.1. 
Primary Efficacy Measurements .................................................................................50 
13.1.1. 
Subject and Investigator Cellulite Assessments .........................................................50 
13.1.1.1. 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) ........................50 
13.1.1.2. 
Subject Global Aesthetic Improvement Scale (S-GAIS)............................................54 

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13.1.1.3. 
Subject Satisfaction with Cellulite Treatment Assessment ........................................54 
13.1.1.4. 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) ....................55 
13.1.1.5. 
Investigator Global Aesthetic Improvement Scale (I-GAIS) .....................................58 
13.1.1.6. 
Hexsel Cellulite Severity Scale ..................................................................................58 
14. 
ASSESSMENT OF SAFETY .....................................................................................60 
14.1. 
Definitions ..................................................................................................................60 
14.1.1. 
Adverse Event .............................................................................................................60 
14.1.2. 
Serious Adverse Event ................................................................................................60 
14.2. 
Monitoring Adverse Events ........................................................................................61 
14.3. 
Relationship to Study Drug ........................................................................................61 
14.4. 
Intensity Assessment ..................................................................................................62 
14.5. 
Reporting Adverse Events and Serious Adverse Events ............................................62 
14.5.1. 
Reporting Adverse Events ..........................................................................................62 
14.5.2. 
Reporting Serious Adverse Events .............................................................................62 
14.5.2.1. 
Follow-up Procedures for Serious Adverse Events ....................................................63 
14.6. 
Special Reporting Situations .......................................................................................63 
14.6.1. 
Adverse Events of Special Interest .............................................................................63 
14.6.2. 
Overdose/Misuse/Abuse .............................................................................................63 
14.6.3. 
Pregnancy ...................................................................................................................64 
14.6.4. 
Adverse Events/Serious Adverse Events Experienced by Non-subjects 
Exposed to Study Medication .....................................................................................64 
14.7. 
Clinical Laboratory and Immunogenicity Determinations .........................................64 
14.7.1. 
Anti-AUX-I and Anti-AUX-II Antibodies .................................................................65 
14.8. 
Vital Signs ..................................................................................................................66 
14.9. 
Electrocardiogram .......................................................................................................66 
14.10. 
Physical Examination .................................................................................................66 
14.11. 
Other Safety Assessments ...........................................................................................67 
15. 
ASSESSMENT OF PHARMACOKINETICS ...........................................................68 
16. 
ASSESSMENT OF PHARMACODYNAMICS ........................................................69 
17. 
STATISTICAL CONSIDERATIONS AND METHODS .........................................70 
17.1. 
Determination of Sample Size ....................................................................................70 
17.2. 
Subject Cohorts and Subject Populations ...................................................................70 
17.2.1. 
Observational Population ............................................................................................70 

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17.2.2. 
Safety Population ........................................................................................................70 
17.2.3. 
Intent-to-Treat Population ..........................................................................................71 
17.2.4. 
Modified Intent-to-Treat Population ...........................................................................71 
17.2.5. 
Per-Protocol Population ..............................................................................................71 
17.3. 
Subject Disposition .....................................................................................................71 
17.4. 
Demographics and Other Baseline Characteristics .....................................................71 
17.5. 
Efficacy Analyses .......................................................................................................71 
17.5.1. 
Primary Efficacy Analysis ..........................................................................................72 
17.5.2. 
Secondary Efficacy Analysis ......................................................................................72 
17.6. 
Safety Analyses ..........................................................................................................75 
17.6.1. 
Prior, Concomitant, and Follow-up Medication .........................................................75 
17.6.2. 
Study Drug Exposure ..................................................................................................76 
17.6.3. 
Measurement of Treatment Compliance ....................................................................76 
17.6.4. 
Adverse Events ...........................................................................................................76 
17.6.5. 
Vital Signs ..................................................................................................................76 
17.6.6. 
Clinical Laboratory Parameters ..................................................................................77 
17.7. 
Immunogenicity Analyses ..........................................................................................77 
17.8. 
Pharmacokinetic Analyses ..........................................................................................77 
17.9. 
Interim Analysis ..........................................................................................................77 
17.10. 
Statistical Software .....................................................................................................77 
18. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................78 
18.1. 
Study Drug Identity ....................................................................................................78 
18.2. 
Study Drug Packaging and Labeling ..........................................................................78 
18.3. 
Study Drug Storage .....................................................................................................78 
18.4. 
Study Drug Preparation ..............................................................................................78 
18.5. 
Study Drug Accountability .........................................................................................78 
18.5.1. 
Study Drug Handling and Disposal ............................................................................79 
19. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................80 
19.1. 
Source Documents ......................................................................................................80 
19.2. 
Study Monitoring ........................................................................................................80 
19.3. 
Audits and Inspections ................................................................................................80 
19.4. 
Institutional Review Board (IRB) ...............................................................................80 
19.5. 
Data Recording and Documentation ...........................................................................80 

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20. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................81 
21. 
ETHICS ......................................................................................................................82 
21.1. 
Ethics Review .............................................................................................................82 
21.2. 
Ethical Conduct of the Study ......................................................................................82 
21.3. 
Subject Information and Consent ...............................................................................83 
22. 
DATA HANDLING AND RECORDINGKEEPING ................................................84 
22.1. 
Data Collection ...........................................................................................................84 
22.2. 
Study Documentation .................................................................................................84 
23. 
REPORTING AND PUBLICATION .........................................................................85 
24. 
INVESTIGATOR OBLIGATIONS ...........................................................................86 
24.1. 
Regulatory Documents ...............................................................................................86 
24.2. 
Delegation of Responsibilities and Adequate Resources ...........................................87 
24.3. 
Medical Care of Study Subjects .................................................................................87 
24.4. 
Use of Investigational Materials .................................................................................87 
24.5. 
Retention of Records ..................................................................................................87 
24.6. 
Subject Confidentiality ...............................................................................................88 
25. 
TERMINATION OF STUDY ....................................................................................89 
26. 
INVESTIGATOR’S AGREEMENT ..........................................................................90 
27. 
REFERENCES ...........................................................................................................91 
APPENDIX A. DOCUMENTS REQUIRED PRIOR TO INITIATION OF THE 
STUDY .......................................................................................................................93 
APPENDIX B. HEXSEL DM, DAL’FORNO T, HEXSEL CL. A VALIDATED 
PHOTONUMERIC CELLULITE SEVERITY SCALE. J EUR ACAD 
DERMATOL VENEREOL. 2009;23(5):523-528. .......................................................95 
APPENDIX C. REFERENCE IMAGES FOR HEXSEL SEVERITY RATINGS ..................103 
APPENDIX D. PATIENT INSTRUCTIONS FOR USE OF PATIENT-REPORTED 
PHOTONUMERIC CELLULITE SEVERITY SCALE (PR-PCSS) .......................104 
 

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LIST OF TABLES 
Table 1: 
Sponsor Contact Information ......................................................................................10 
Table 2: 
Observation Assessments ...........................................................................................17 
Table 3: 
Treatment Session Assessments .................................................................................18 
Table 4: 
Abbreviations and Specialist Terms ...........................................................................26 
Table 5: 
Concomitant Medication Restrictions for Subjects During the Treatment 
Phase of Study ............................................................................................................48 
Table 6: 
Subject Global Aesthetic Improvement Scale (S-GAIS)............................................54 
Table 7: 
Subject Satisfaction with Cellulite Treatment Assessment ........................................55 
Table 8: 
Investigator Global Aesthetic Improvement Scale (I-GAIS) .....................................58 
Table 9: 
Hexsel Cellulite Severity Scale ..................................................................................59 
Table 10: Clinical Laboratory Parameters ..................................................................................65 
Table 11: Vital Signs Measurements on Injection Day ..............................................................66 
 
LIST OF FIGURES 
Figure 1: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the 
Buttock ........................................................................................................................52 
Figure 2: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the 
Thigh ...........................................................................................................................53 
Figure 3: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for 
the Buttock ..................................................................................................................56 
Figure 4: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for 
the Thigh .....................................................................................................................57 
 
 

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7. 
LIST OF ABBREVIATIONS  
The following abbreviations and specialist terms are used in this study protocol. 
Table 4: 
Abbreviations and Specialist Terms 
Abbreviation 
Definition 
AE 
Adverse event 
Assigned quadrant 
Assigned quadrant (ie, left or right buttock, or the left or right posterolateral thigh) that 
was suitable for treatment and was randomly assigned in the double-blind study 
(EN3835-201). To be suitable for treatment the quadrant must have an Investigator 
CR-PCSS and subject PR-PCSS score of 3 or 4 and a Hexsel CSS score of no greater 
than 13 at Screening B visit and at Day 1 visit. 
AUX-I 
Clostridial class I collagenase 
AUX-II 
Clostridial class II collagenase 
CFR 
Code of Federal Regulations 
CRF 
Case report form 
CR-PCSS 
Clinician-Reported Photonumeric Cellulite Severity Scale 
CSS 
Cellulite Severity Scale 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EFP 
Edematous fibrosclerotic panniculopathy 
FDA 
Food and Drug Administration 
GCP 
Good clinical practice 
HREC 
Human research ethics committee 
IB 
Investigator Brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent ethics committee 
I-GAIS 
Investigator Global Aesthetic Improvement Scale 
IND 
Investigational new drug 
IRB 
Institutional review board 
ITT 
Intent-to-treat 
kDa 
Kilodalton 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
Modified intent-to-treat 
PCS 
Potentially clinically significant 
PR-PCSS 
Patient-Reported Photonumeric Cellulite Severity Scale 
Qualified designee 
Qualified by education and training to perform the study procedure (eg, 
sub-Investigator, nurse) 
SAE 
Serious adverse event 

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Table 4: 
Abbreviations and Specialist Terms (Continued) 
Abbreviation 
Definition 
SAP 
Statistical Analysis Plan 
Selected quadrant 
Quadrant (ie, left or right buttock, or the left or right posterolateral thigh) that is suitable 
for treatment and is selected by patient and investigator for treatment. To be suitable for 
treatment the quadrant must have an Investigator CR-PCSS and subject PR-PCSS score 
of at least 3 or 4 and a Hexsel CSS score of no greater than 13 at Screening B visit. 
S-GAIS 
Subject Global Aesthetic Improvement Scale 
TEAE 
Treatment-emergent adverse event; adverse events that occur on or after the first 
injection of study drug 
 

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8. 
INTRODUCTION 
8.1. 
Edematous Fibrosclerotic Panniculopathy 
Edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite, has been defined 
as a local metabolic disorder of subcutaneous tissues that results in an alteration of skin 
topography.(1) The condition manifests as dimpled skin, described as an orange-peel, cottage 
cheese, or mattress texture, particularly in the gluteal-femoral region.(2,3) EFP is caused by 
herniation of subcutaneous fat lobules through the dermohypodermal junction. This creates an 
uneven surface with dimpling.(1) EFP is a medical condition resulting in a potentially 
cosmetically unacceptable alteration of the skin, and affects an estimated 85% to 98% of 
postpubertal women.(1,3) 
The pathophysiology of EFP is not completely understood, but there are 3 main theories: edema 
resulting from excessive hydrophilia of the intercellular matrix, alteration of the regional 
microcirculation, and different anatomical conformation of collagenous subcutaneous tissues in 
women versus men.(4) 
It is known that EFP is different from generalized obesity. In generalized obesity, adipocytes 
undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs, and abdomen.(1) 
In areas of EFP, adipocytes have physiologic and biochemical properties that differ from adipose 
tissue located elsewhere. Large, metabolically-stable adipocytes characterize EFP-prone areas; 
thus, the responsiveness to catecholamine-induced lipolysis is less in EFP tissues compared to 
visceral fat, which has the greatest responsiveness.(1) 
Subcutaneous fat lobes are separated from one another by thin, usually rigid strands of 
collagenous connective tissues, which cross the fatty layers and connect the dermis to the 
underlying fascia. These septa stabilize the subcutis and divide the fat. In EFP, shortening of the 
collagen septa due to fibrosis provokes retraction at the insertion points of the trabeculae, 
causing the depressions that characterize EFP.(2) There are a higher percentage of thinner, 
perpendicular hypodermal septa in women with EFP than in men.(1) Weight gain makes EFP 
more noticeable, but it may be present even in thin subjects. Genetics may also play a role since 
EFP tends to run in families. 
8.2. 
Current Edematous Fibrosclerotic Panniculopathy Treatments 
There are therapies that have been utilized in an attempt to treat cellulite. Despite multiple 
therapeutic modalities, there is little scientific evidence that any of these treatments are 
beneficial. In fact, much of the evidence is anecdotal, subjective, or based only on patient self-
assessment.(5) Some of the historical treatments for EFP have included: 
x Weight loss: Weight loss generally decreases the severity of EFP but may only have a 
variable effect on EFP grades.(6) 
x Pharmacological agents (eg, xanthines, retinoids, lactic acid, and herbals): Although 
there are numerous topical treatments that are available over the counter, there are no 
well-designed or large-scale studies demonstrating the effectiveness of any of these 

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therapies.(5) Additionally, ingredients in some of the topical treatments are unknown 
and may pose an increased risk for adverse effects.(5) 
x Massage: Endermologie or lipomassage kneads the skin between rollers. This type of 
vigorous massage is posited to increase blood flow and reduce excess fluid in EFP 
prone areas. In a 12-week, randomized, controlled study of 52 women that examined 
the effectiveness of either endermologie or aminophylline versus a combination of 
both, there was no statistical difference in the thigh measurement between 
subjects.(7) 
x Liposuction: Liposuction can reshape the body, but it does not typically correct 
cellulite as it does not interrupt collagen septae in a directed fashion. Additionally, 
liposuction is not a recommended treatment for cellulite given the potential for poor 
cosmetic outcome.(5,6) 
x Mesotherapy: Mesotherapy involves injecting solutions containing various 
substances, eg, methylxanthines, to dissolve subcutaneous fat; however, this type of 
therapy often results in unwanted side effects, including infection, urticarial reactions, 
and bumpy or uneven skin contours.(6) To date, there are no regulatory approved 
mesotherapy mixtures for the treatment of EFP. 
x Radiofrequency: Radiofrequency systems may temporarily improve the appearance of 
EFP after a series of treatments; but long-term efficacy has not been demonstrated.(6) 
x Subcision: Subcision is an invasive surgical technique that severs the septa holding 
fat lobules that cause the skin dimpling associated with EFP. In a study conducted by 
Hexsel and Mazzuco, 232 subjects had subcision for the treatment of EFP.(8) 
Although 78% of subjects were satisfied after 1 treatment, there were no objective 
criteria by which to assess improvement, thereby limiting the value of this study. 
Additionally, side effects reported in this study included pain, bruising for 3 to 
6 months, hyperpigmentation for 2 to 10 months, and skin puckering.(5,6) These 
effects are most likely due to the trauma from shearing the septa with a large gauge 
needle (eg, 16 or 18 gauge) or other cutting devices. 
x Powered subcision: Powered subcision is a surgical technique utilizing a powered 
needle apparatus to sever the septa holding fat lobules that cause skin dimpling 
associated with EFP. The Cellfina® powered subcision device was recently approved 
by Food and Drug Administration (FDA; 2015) for the treatment of cellulite. 
x Laser: Intense pulsed light has been investigated for the treatment of cellulite. 
Triactive® is an FDA-approved low-fluorescence 810-nm light source combined with 
a 915-nm laser. In a study of 16 female subjects who underwent 12 treatments with 
the Triactive, 21% had improvement (based on 5 blinded Investigators’ analysis of 
photographs with respect to appearance of cellulite, skin tone, and texture) of their 
cellulite.(9) The CelluLaze™ system was used to treat cellulite on the thighs of 
10 healthy women.(10) In this Investigator-initiated study, subjects received a single 
treatment with a 1440-nm laser. During the CelluLaze procedure, which is performed 
under a local tumescent and general anesthetic, the physician inserts a small cannula 
through the skin and the device technology directs controlled, laser thermal energy to 

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the treatment zones. The laser is designed to diminish the lumpy pockets of fat by 
melting the hypodermal fat; release the areas of skin depression through thermal 
subcision of the septal tissue; and increase the elasticity and thickness of the skin by 
melting the fat in the dermal invaginations. Subjective physician and subject 
evaluations indicated improvement in the appearance of cellulite and high patient 
satisfaction that persisted for a year. For both the Triactive and CelluLaze studies, 
there were no control groups and significance was not tested.  
There remains an unmet medical need for safe and effective nonsurgical therapies to improve the 
esthetic outcome in women with cellulite. To effectively treat cellulite, a therapeutic approach 
may require disruption of the dermal septa, which are composed of collagen and cause the skin 
dimpling which is bothersome to many women. 
8.3. 
EN3835 (Collagenase Clostridium Histolyticum) 
Endo Pharmaceuticals Inc. (Endo) is developing EN3835 for the treatment of EFP. Because 
EN3835 is a proteinase that can hydrolyze the triple-helical region of collagen under 
physiological conditions, EN3835 has the potential to be effective in lysing subdermal collagen, 
such as those observed in the dermal septa, which are the underlying cause of the skin dimpling 
in women with EFP. EN3835 targets the collagenase structural matrix (eg, dermal septa) at the 
site of injection and does not require systemic exposure to be effective. 
EN3835 is a parenteral lyophilized product comprised of 2 collagenases in an approximate 
1:1 mass ratio, Collagenase I (AUX-I, Clostridial class I collagenase) and Collagenase II 
(AUX-II; Clostridial class II collagenase). These collagenases are isolated and purified from the 
fermentation of Clostridium histolyticum. Collagenase AUX-I is a single polypeptide chain 
containing approximately 1,000 amino acids of known sequence and with a molecular weight of 
114 kDa. Collagenase AUX-II is also approximately 1,000 amino acids long and has a molecular 
weight of 113 kDa. These 2 collagenases are not immunologically cross-reactive and have 
different specificities, such that together they become synergistic, providing a very broad 
hydrolyzing reactivity toward collagen. Clostridial collagenases are proteinases that can 
hydrolyze the triple-helical region of collagen under physiological conditions. 
EN3835 is currently approved for: 1) the treatment of adults with Dupuytren’s contracture with a 
palpable cord and, 2) for the treatment of adult men with Peyronie’s disease with a palpable 
plaque and curvature deformity of at least 30 degrees at the start of therapy. 
8.3.1. 
Studies with EN3835 for the Treatment of Edematous Fibrosclerotic 
Panniculopathy 
The studies summarized in this section are described in more detail in the Investigator’s 
Brochure (IB). 
8.3.1.1. 
Investigator-Initiated Proof-of-Concept Study 
In an Investigator-initiated pilot study, 10 female subjects received EN3835 in the treatment of 
cellulite.(11) A 10×10-cm oval area was outlined on the posterolateral thigh and 0.58 mg 
EN3835 was injected using a template as 5 concurrent subcutaneous injections of 0.116 mg per 
injection. Subjects were followed up to 180 days after injection for reduction of the cellulite 
appearance in the injected area. At 1 month post injection, the area of cellulite (as measured from 

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photographs) was reduced 89% from baseline. Patient satisfaction score was 1.75 at month 6 
(1=completely satisfied, 4=not satisfied). Side effects included the local events of injection area 
soreness, ecchymosis, and mild edema; these resolved within a mean of 18 days. The results 
from this study suggest that the collagen septa of EFP may be an appropriate substrate for lysis 
with injectable collagenase, and that treatment with collagenase appears to be tolerable and 
possibly effective. However, due to the paucity of the data, no conclusions could be drawn 
regarding dose, frequency, and injection technique. 
8.3.1.2. 
Endo-Sponsored Phase 1b Dose-Escalation Study AUX-CC-830 
A dose-ranging Phase 1b dose escalation study (AUX-CC-830) used a template arrangement of 
injections as was used in the Investigator-initiated pilot study but injected a matrix of doses, 
concentrations and injectate volumes to select doses for further development. This Phase 1b 
study showed efficacy results suggesting that collagenase clostridium histolyticum (CCH) may 
be effective in the treatment of EFP based on global aesthetic improvement at Day 90 with 
ratings of “improved” by 43.4% of Investigators and 52.5% of subjects. The majority of subjects 
(71.7%) were “quite satisfied” or “very satisfied” with treatment on Day 90. Adverse 
events(AEs) were local injection site events (bruising, pain, erythema, and edema) were mild or 
moderate and resolved within a period of 3 weeks. 
8.3.1.3. 
Endo-Sponsored Phase 2a Dose-Ranging Study AUX-CC-831 
The Phase 2a study (AUX-CC-831) was a double-blind, placebo-controlled, dose-ranging study 
of 150 women randomized to 0.06, 0.48, or 0.84 mg of CCH; or placebo in a 5:5:5:3 ratio. Each 
subject could receive up to 3 treatment sessions of study drug separated by approximately 
21 days. Efficacy in this study was evaluated based on Investigator Global Aesthetic 
Improvement Scale (GAIS-I) and Subject Global Aesthetic Improvement Scale (GAIS-S) along 
with other measures of treatment efficacy. Improvements were observed in cellulite appearance 
based on the statistically significant changes in the appearance of cellulite based on both the 
GAIS-I and GAIS-S scores for the high and mid doses compared to placebo (p<0.05). The 
majority of the patients were either satisfied or very satisfied with the results of their cellulite 
treatment with the mid and high doses compared to placebo (p<0.05). Similar to the AEs 
reported in subjects in the previous study (AUX-CC-830) and subjects who received EN3835 for 
Dupuytren’s contracture and Peyronie’s disease, the majority of AEs occurred at the site of 
injection and resolved before the next scheduled treatment session. 
8.3.1.4. 
Endo-Sponsored Phase 2b Study EN3835-201 
Currently there is an ongoing Phase 2b study (EN3835-201) which is a double-blind, placebo-
controlled study of 350 adult women randomized to EN3835 0.84 mg or placebo in a 1:1 ratio. 
Each subject can receive up to 3 treatment sessions of study drug separated by approximately 
21 days; last visit is Day 71. Efficacy is being evaluated using a Clinician-Reported 
Photonumeric Cellulite Severity Scale (CR-PCSS), a Patient-Reported Photonumeric Cellulite 
Severity Scale (PR-PCSS), the Hexsel Cellulite Severity Scale (CSS), Investigator Global 
Aesthetic Improvement Scale (I-GAIS), Subject Global Aesthetic Improvement Scale (S-GAIS), 
and a subject satisfaction assessment. Subjects that complete study EN3835-201 will be offered 
the option of participating in study EN3835-202. 

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8.4. 
Summary of Nonclinical Studies 
Nonclinical studies necessary to support clinical studies have been performed and are 
summarized in the IB. Nonclinical studies in the following areas were performed: toxicology, 
reprotoxicity, genotoxicity, and carcinogenicity.  
8.5. 
Summary of Known Risks and Benefits 
A summary of safety risks is provided in the IB. The following events have been commonly 
observed in prior studies: injection site AEs such as bruising, edema, erythema and pain. 
There are previously generated potential clinical benefits associated with EN3835 in treating 
EFP, however, such potential benefits need further clinical evaluation. It is hoped that data from 
this clinical study will demonstrate a measurable sustained or durable clinical benefit of EN3835 
in EFP as well as longer term safety.  
8.6. 
Rationale 
This study will allow an evaluation of longer term safety (over 12 months) following EN3835 
treatment of subjects with EFP. Additionally, although uncontrolled, an assessment of cellulite 
assessments (efficacy) of EN3835 in the treatment of quadrants with moderate or severe cellulite 
will be conducted in subjects treated with placebo or EN3835 in the previous double-blind study 
(EN3835-201). The safety of re-dosing either in a previously treated quadrant (termed 
re-treatment) or in a naive quadrant (termed re-dosing) in subjects that previously received 
EN3835 treatment in study EN3835-201 will be assessed. Finally, the durability of improvement 
will be evaluated in enrolled subjects following EN3835 treatment in the double-blind study 
(EN3835-201) as well as those being treated with EN3835 in this open-label study 
(EN3835-202). 
 

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9. 
OBJECTIVES 
9.1. 
Primary Objective 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at scheduled 
intervals over 1 year (12 months) in all subjects with EFP who elect to enroll in this open-label 
trial regardless of their decision to receive treatment (re-treatment or re-dosing) of open-label 
EN3835 or opt to receive no treatment.  
9.2. 
Secondary Objectives 
x To assess safety and immunogenicity of re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
x To evaluate the durability of response to EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects previously receiving active-treatment in 
study EN3835-201 using the PR-PCSS and the CR-PCSS 
x To evaluate long-term response to EN3835 in assessments of EFP including subject 
satisfaction, I-GAIS, and S-GAIS 
x To assess cellulite severity assessments in quadrants treated in this study with 
EN3835 
x To evaluate immunogenicity after exposure to EN3835 
9.3. 
Exploratory Objectives 
There are no exploratory objectives for this open-label extension study. 
 

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10. 
INVESTIGATIONAL PLAN 
10.1. 
Study Design 
This open-label extension study will be performed at multiple centers currently participating in 
the double-blind, placebo-controlled, parent trial (EN3835-201) in the United States. The open-
label extension study will enroll up to 350 subjects. The study is planned to end when at least 
100 subjects have 12 months after exposure ie 12 months after first treatment in study 
EN3835-201 or study EN3835-202. Subjects who completed the entire double-blind study and 
sign an informed consent will be eligible to enter this open-label extension.  
After the Sponsor has broken the EN3835-201 study drug blind, subjects enrolled in the open-
label study will have the following options: 
x To have no EN3835 treatments in study EN3835-202 
x If received EN3835 in study EN3835-201, may elect to have a qualifying quadrant 
other than the one treated in study EN3835-201 treated with EN3835 (termed 
re-dosing) 
x If received EN3835 in study EN3835-201 and the cellulite severity scores of the 
treated quadrant have returned to or are greater than EN3835-201 baseline scores, 
may elect to have the previously treated quadrant retreated with EN3835 (termed 
re-treatment) 
x If received placebo in study EN3835-201, may elect to have a qualifying quadrant 
treated with EN3835; also may elect to have a second qualifying quadrant treated 
with EN3835 after completing the treatment course  
Subjects enrolled in study EN3835-202 who elect to receive EN3835 treatment (either 
re-treatment, re-dosing, or a first treatment) must meet specific inclusion and exclusion criteria 
for eligibility during re-screening (Screening B) prior to EN3835 dosing.  
Following completion of safety and cellulite assessments at Day 71 of the double-blind study 
(EN3835-201), subjects will be asked if they wish to continue in the open-label extension to the 
double-blind study (Screening A). At the time of entry into the open-label study, subjects and 
Investigators will remain blinded to study drug. Until the EN3835-201 study drug blind is broken 
by the Sponsor, subjects will undergo observation-only visits at 3-month intervals ± 7 days 
(relative to the initial dose in the double-blind study) where both safety and cellulite severity 
assessments of the treated quadrant will be made. 
Following the study drug blind being broken and communicated to centers, eligible subjects may 
elect to receive EN3835 treatment. Subjects electing not to receive further EN3835 treatments 
(observation-only subjects) will continue to be followed for safety and cellulite severity 
assessments at 3-month intervals through month 12. Up to 14 days prior to initiating treatment 
injections of EN3835 on open-label treatment visit Day 1, subjects will undergo a screening 
evaluation (Screening B) to determine if they meet specified inclusion and exclusion criteria and 
to determine the quadrants, if any, that qualify for treatment.  

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During Screening B, photographs will be taken of each of the subject’s 4 quadrants (left buttock, 
right buttock, left posterolateral thigh, and right posterolateral thigh). Subjects will again receive 
instructions for use of the PR-PCSS and will subsequently use the scale to rate the severity of 
their cellulite in each of the 4 quadrants by comparing digital images of each of their quadrants 
displayed on standardized computer monitors with the PR-PCSS instrument. This independent 
self-assessment will take place in a private setting to minimize any potential bias from site 
personnel. The Investigator will then assess the subject’s 4 quadrants live in real-time using the 
CR-PCSS. The Investigator will rate the 4 quadrants using the Hexsel CSS as described in 
section 13.1.1.6.(12) Subjects must have at least 1 quadrant that meets the following criteria for 
inclusion into the treatment phase of the study: 
1. PR-PCSS score of 3 or 4, and 
2. CR-PCSS score of 3 or 4, and  
3. Hexsel CSS score of no greater than 13. 
After the independent assessments are completed separately by the subject and the Investigator, 
the Investigator will review his/her assessments and the subject’s assessment to determine which 
quadrants, if any, are eligible. The eligible quadrant chosen to receive treatment in the open-label 
study EN3835-202 will be at the discretion of the subject. A quadrant may be chosen for 
re-treatment if it was the quadrant treated in study EN3835-201 or a new quadrant may be 
chosen for re-dosing. NOTE: For subjects who received active drug in the assigned 
quadrant in the double-blind study, the quadrant must have cellulite severity at (or 
greater) than the EN3835-201 baseline scores of PR-PCSS and CR-PCSS to qualify for 
re-treatment. 
Previously placebo-treated subjects will have the option to receive a second course of EN3835 in 
the same or different qualifying quadrant after at least 28 days following the end of the first 
treatment course (ie treatment of second quadrant could begin on Day 71 after treating the first 
quadrant). The selected quadrant can be re-treated or re-dosed.  
At each treatment session visit, Investigators will select the dimples within the chosen quadrant 
to be treated. Selection of dimples to be treated in the quadrant will be at the discretion of the 
Investigator. The selected EFP dimples in the selected quadrant must be well-defined and evident 
when the subject is standing in a consistent relaxed pose (without the use of any manipulation 
such as skin pinching or muscle contraction). The dimples selected to be treated will be circled 
with a surgical marker and injection site locations should be marked with a dot; if more than 
1 injection per dimple is needed, the injection sites should be separated by approximately 2 cm. 
The selected quadrant will be photographed again after marking dimples. Subjects will be 
administered a maximum of EN3835 0.84 mg from a total of up to 12 injections. Up to 
12 injections will be administered at each treatment session to treat the selected quadrant. Each 
of the injections will be administered as three 0.1-mL aliquots (total injection volume per 
injection is 0.3 mL; total injection volume per treatment session is 3.6 mL [12 injections × 
0.3 mL], see table below).  

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Subjects will receive 3 treatment sessions (Day 1, Day 22, and Day 43) unless the chosen 
quadrant has no further treatable EFP dimples and the Investigator rates the quadrant a score of 0 
on the CR-PCSS. The same dimples within a quadrant or different dimples within a quadrant 
may be treated at each session but injections must all be within the selected quadrant for all 
3 sessions. Each treatment session will be separated by approximately 21 days. 
Dose per 
Each Injectiona 
Injection 
Volume per 
Each Injection 
Maximum 
Number of 
Injections per 
Each Treatment 
Session 
Maximum Dose 
(mg) per Each 
Treatment 
Session 
Maximum 
Injection Volume 
(mL) per Each 
Treatment 
Session 
Maximum 
Cumulative EFP 
Dose 
EN3835 0.07 mg 
N=333 
0.3 mL 
12 injections  
0.84 mg 
(12 injections  
× 0.07 mg) 
3.6 mL 
(12 injections  
× 0.3 mL) 
2.52 mg 
(3 treatment sessions 
× 0.84 mg) 
a Each injection of EN3835 is 0.3 mL administered as three 0.1-mL aliquots.  
The complete Schedule of Events is provided in section 5 (Table 2 and Table 3) and summarized 
in section 12. 
10.2. 
Selection of Doses 
Maximum possible doses of EN3835 employed will be the same as that administered in the 
double-blind, placebo-controlled, parent study (EN3835-201). 
10.3. 
Study Drug Administration 
Study drug in the form of sterile vials of lyophilized EN3835 (formerly AA4500) and sterile 
diluent will be provided by Endo. Study drug administration at each injection site is presented in 
section 12.1.4.2. 
10.4. 
Discussion of Study Design, Including the Choice of Control Groups 
The use of the open-label extension design allows for the following: 
x Safety data over a 12-month period will be collected to assist in further defining the 
safety profile of EN3835 in this population, 
x Safety data and immunogenicity after repeat exposure (re-treatment/re-dosing) and 
monitoring of previously active-treated subjects to EN3835 over a 12-month period,  
x Previously placebo-treated subjects to have exposure to EN3835, and  
x Durability of the response to EN3835 (cellulite severity assessments) will be 
assessed.  

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11. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
11.1. 
Observation Phase 
All subjects who have completed the double-blind study EN3835-201 and sign the informed 
consent are eligible for enrollment in this open-label extension study and participation in the 
ongoing safety and cellulite evaluations.  
11.1.1. 
Subject Inclusion Criteria for Observation 
To qualify for this open-label observation study a subject must: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201  
3. Be willing to apply sunscreen to any treated quadrant before each exposure to the sun 
while participating in the study (ie, screening through end of study) 
11.1.2. 
Subject Exclusion Criteria for Observation 
None 
11.2. 
Treatment 
Inclusion and exclusion criteria presented in section 11.2 apply only to those subjects in the 
open-label study who choose treatment. 
At the time that the study drug blind is broken in the double-blind study EN3835-201, qualified 
subjects enrolled in the open-label study are eligible for treatment. A subject may participate in 
the observational period of this open-label study regardless of scoring of quadrant; however to 
receive treatment in this study, a subject must have at least 1 qualifying quadrant. 
11.2.1. 
Subject Inclusion Criteria for Treatment 
To qualify for treatment in the study a subject must: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be a female 8 years of age 
4. At Screening B visit, have at least 1 quadrant with: 
a. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 
b. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and 
c. a Hexsel CSS score no greater than 13 
5. Be willing to apply sunscreen to the selected treatment quadrant before each exposure to 
the sun while participating in the study (ie, Screening B through end of study) 
6. Be judged to be in good health, based upon the results of a medical history, physical 
examination, and laboratory profile at Screening B 

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7. Have a negative urine pregnancy test at Screening B and before injection of study drug 
and be using an effective contraception method (eg, abstinence, intrauterine device 
[IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at 
least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be 
menopausal defined as 12 months of amenorrhea in the absence of other biological or 
physiological causes, as determined by the Investigator; or post-menopausal for at least 
1 year; or be surgically sterile. 
8. Be willing and able to cooperate with the requirements of the study 
9. Be able to read, complete and understand the patient-reported outcomes rating 
instruments in English 
11.2.2. 
Subject Exclusion Criteria for Treatment 
A subject will be excluded from treatment in the study (but not from the observation 
assessments) if she: 
1. Has used any of the following for the treatment of EFP on the legs or buttock within the 
timelines identified below or intends to use any of the following at any time during the 
course of the study: 
x Liposuction on the side of the body selected for treatment during the 12-month period 
before injection of study drug 
x Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or 
surgery (including subcision and/or powered subcision) within the selected treatment 
quadrant during the 12-month period before injection of study drug 
x Endermologie or similar treatments within the selected treatment quadrant during the 
6-month period before injection of study drug 
x Massage therapy within the selected treatment quadrant during the 3-month period 
before injection of study drug 
x Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected 
treatment quadrant during the 2-week period before injection of study drug 
2. Is presently nursing a baby or providing breast milk for a baby 
3. Intends to become pregnant during the study 
4. Has received an investigational drug or treatment within 30 days before injection of study 
drug 
5. Has a known systemic allergy to collagenase or any other excipient of study drug 
6. Is currently receiving or plans to receive anticoagulant or antiplatelet medication or has 
UHFHLYHGDQWLFRDJXODQWRUDQWLSODWHOHWPHGLFDWLRQH[FHSWIRU mg aspirin daily) 
within 7 days before injection of study drug 
7. Has a known recent history of stroke, bleeding, or other medical condition, which in the 
investigator’s opinion would make the subject unsuitable for enrollment in this phase of 
the study 

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8. Presence of any clinically relevant conditions, that in the opinion of the Investigator 
would interfere with completing the study including, but not limited to, visual problems, 
hearing problems, cognitive impairment or acute mental illness 
11.3. 
Subject Discontinuation Criteria 
A premature discontinuation will occur when a subject who signed informed consent ceases 
participation in the study, regardless of circumstances, prior to the completion of the protocol. 
Subjects can be prematurely discontinued from the study for one of the following reasons: 
x An adverse event (AE) 
x A protocol violation (reason must be specified, for example: lack of compliance, use 
of a prohibited concomitant medication, failure to meet inclusion/exclusion criteria 
after study entry, etc) 
x Withdrawal by subject (reason must be specified) 
x The subject was “lost to follow-up”  
x Other reasons (reason must be specified, for example: the subject moved, pregnancy, 
investigator decision, Sponsor decision to terminate trial, etc) 
If a subject discontinues from the study, all end-of-study procedures should be conducted as 
detailed in Schedule of Events. The date a subject discontinues and the reason for 
discontinuation will be recorded in the source documentation and Electronic Case Report Form 
(eCRF). If, however, a subject withdraws consent, no end-of-study procedures are required 
except the collection of AE information. This information should be recorded in the source 
documentation and the eCRF.  
11.3.1. 
Replacement Procedures 
Subjects who discontinue prematurely from the study will not be replaced. 

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12. 
PROCEDURES AND TREATMENTS 
12.1. 
Study Visits 
The Schedule of Events to be performed at each visit is shown in section 5. Provided below are 
further details where additional instruction about the assessments that will be performed is 
deemed to be needed. 
12.1.1. 
Subject Screening 
Upon completion of Day 71 assessments in the double-blind study EN3835-201, a subject will 
be eligible to enter this open-label extension study. Investigators will be expected to maintain a 
Screening Log of all potential study subjects. This log will include limited information about the 
potential subject and the date and outcome of the screening process (eg, enrolled into the study, 
reason for ineligibility, or refused to participate). Investigators will provide information about the 
study to subjects who appear to meet the criteria for participation in the study. 
12.1.2. 
Screening Assessments 
After obtaining informed consent, the full assessment of eligibility will be conducted and prior to 
study entry, screening assessments will be performed. Details about how the informed consent 
will be obtained and documented are provided in section 21.3, Subject Information and Consent. 
The subject may be entered into the observational phase of the study and complete safety and 
cellulite severity assessments at 3-month intervals as detailed in Table 2. In addition, once the 
study blind is broken in study EN3835-201, enrolled subjects will be asked if they wish to 
receive additional open-label treatments. If a subject elects to receive open-label treatment, study 
assessments will be conducted in accordance with Table 3. 
12.1.3. 
Study Entry/Observational Assessments 
A subject who gives written informed consent and who satisfies all eligibility criteria 
(section 11) may be entered into the observational phase of the study and complete safety and 
cellulite severity assessments at 3-month intervals as detailed in Table 2. The first visit will be 
determined by the date of enrollment in study EN3835-202 relative to the Schedule of Events for 
study EN3835-202 (Table 2). For example, if a subject enrolls after the Day 90 visit window, the 
first observation visit for that subject would be Day 180. In addition, once the study drug blind is 
broken in study EN3835-201, enrolled subjects will be asked if they wish to receive additional 
open-label treatments. If a subject elects to receive open-label treatment, study assessments will 
be conducted in accordance with Table 3. The subject identification number will be carried over 
from the double-blind, placebo-controlled study (EN3835-201). 
12.1.3.1. Three-Month Assessments 
Subjects will return within 20 days (±4 days) of completion of the double-blind study for the first 
of 4 safety and cellulite severity evaluation visits. Assessments to be completed at these visits are 
detailed in Table 2. Subjects are to return at 3-month intervals until they have completed 
12 months from Day 1 of the double-blind study. At these visits, the quadrant previously treated 
with EN3835 in the EN3835-201 study or quadrants treated with EN3835 in the open-label study 

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will be evaluated. If the quadrant treated in study EN3835-201 is retreated in the open-label 
study, the 3-month assessments will reset to treatment visit 1/Day 1 of the open-label treatment 
and the study visits will continue as described in Table 3 followed by 3-month assessments as 
described in Table 2. If a different quadrant is treated in the open-label study, the 3-month 
assessments of both the quadrant treated in the double-blind study (EN3835-201) and the 
quadrant treated in the open-label study will continue. 
12.1.4. 
Treatment Assessments (Optional) 
After unblinding of treatment assignment in the EN3835-201 study, subjects are eligible for 
optional treatment in the open-label study, provided they meet the inclusion and exclusion 
criteria detailed in section 11 and at least 1 quadrant meets the criteria for treatment. A subject 
may receive a maximum of 2 courses of treatment (6 treatment sessions) overall (total of 
treatments in double-blind and open-label study). If a subject received placebo in the double-
blind study, she may be eligible for 2 treatment courses in the open-label study; if a subject 
received active drug in the double-blind study, she may be eligible for 1 additional treatment 
course (3 treatment sessions) in the open-label study.  
Selection of Treatment Quadrant 
During the Screening B visit, each subject will have photographs taken of the 4 targeted 
quadrants of the study (eg, their left and right buttocks and left and right posterolateral thighs). 
Subjects will receive instructions (Appendix D) for using the PR-PCSS and will use the scale to 
rate the severity of their cellulite in each of the 4 quadrants by comparing each of their digital 
image photographs with the PR-PCSS instrument. This self-assessment will take place in a 
private setting to minimize any potential bias from site personnel. The Investigator will then 
assess each of the subject’s 4 quadrants live in real-time using the CR-PCSS. The Investigator 
will then examine each of the 4 quadrants live to assess the subject using the Hexsel CSS as 
described in section 13.1.1.6.(12) Subjects must have at least 1 quadrant that meets the following 
criteria for treatment in the study: 
1. PR-PCSS score of 3 or 4, and 
2. CR-PCSS score of 3 or 4, and  
3. Hexsel CSS score no greater than 13.  
After the independent assessments are completed separately by the subject and the Investigator, 
the Investigator will review his/her assessments and the subject’s assessment to determine which 
quadrants, if any, are eligible. The eligible quadrants (must meet all 3 of the inclusion criteria 
(PR-PCSS, CR-PCSS, and Hexsel CSS scores), if any, for treatment will be determined by the 
Investigator after which the quadrant selected will be at the discretion of the subject. For subjects 
treated with EN3835 in the double-blind study, if the quadrant treated in the double-blind study 
(EN3835-201) has PR-PCSS and CR-PCSS ratings identical or more severe than the double-
blind study (EN3835-201) PR-PCSS and CR-PCSS baseline ratings (Baseline is Day 1 of study 
EN3835-201), subjects can elect to have that same quadrant re-treated. Subjects who choose 
re-treatment of the previously treated quadrant will be classified in the re-treatment arm. If 
another quadrant besides the previously treated quadrant meets all 3 of the inclusion criteria, 
subjects can choose to be treated in the naive quadrant. Subjects who choose treatment into a 
naive quadrant will be classified in the re-dosing arm. 

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Assessments made with the PR-PCSS (from digital image), the CR-PCSS (live assessment), and 
the Hexsel CSS score during the open-label Screening B visit will be the baseline severity of 
EFP in the selected quadrant.  
A subject who received placebo in the double-blind study may be treated in the same quadrant in 
the open-label study if the quadrant still meets all 3 criteria OR another qualifying quadrant may 
be selected for treatment by the subject. Following Day 71 of a treatment course (3 treatment 
sessions), subjects can choose to receive a second treatment session in either the same quadrant if 
it still meets qualification criteria or in a different quadrant that meets qualification criteria. For 
the first treatment course, these subjects will be considered in the treatment arm. For the second 
treatment course, if the same quadrant is treated, subjects will be in the re-treatment arm; if a 
different quadrant is treated, subjects will be considered in the re-dosing arm.  
If no quadrant meets all 3 criteria, the subject may continue in the observation-only study with 
safety and cellulite severity evaluations performed at 3-month intervals but may not receive 
treatment in this study. 
Selecting and Marking Dimples 
Selection of dimples to be treated in the selected quadrant is at the discretion of the Investigator 
or qualified designee. Dimples must be well-defined and evident when the subject is standing in 
a consistent relaxed pose (without the use of any manipulation such as skin pinching or muscle 
contraction). Each subject will receive 3 treatment sessions of study drug in the selected 
quadrant. During each treatment session, the treatment quadrant will be photographed before and 
after dimple marking while the subject is standing in a consistent relaxed pose as described in the 
Photography Manual. The cellulite severity assessments using the PR-PCSS and CR-PCSS will 
be completed prior to dimple marking at treatment visits 2, 3, and 4/end of treatment. 
12.1.4.1. Screening B (Days í14 to í1 Relative to Open-Label Treatment Visit Day 1) 
Subjects meeting the relevant criteria listed in section 11.2 may be eligible for treatment in the 
open-label study. The following procedures will be performed and documented during the 
screening period: 
1. Evaluate eligibility based on inclusion/exclusion criteria (section 11.2)
2. Subject will have digital photographs taken of the 4 targeted quadrants of the study (left
and right buttocks, and left and right posterolateral thighs) (section 13.1)
3. Subjects will get instruction on the use of the PR-PCSS (Appendix D)
4. Subjects will rate each quadrant using the PR-PCSS while viewing their digital images
(section 13.1.1.1)
5. The Investigator will conduct independent live assessments of subject’s cellulite severity
of each quadrant using the CR-PCSS (section 13.1.1.4) after the subject completes her
rating and with no knowledge of the subject's ratings of her quadrants.
6. The Investigator will conduct live cellulite evaluation of each quadrant using the Hexsel
CSS (section 13.1.1.6).

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7. If at least 1 quadrant qualifies based on PR-PCSS, CR-PCSS, and Hexsel CSS ratings, 
subject may return for treatment on treatment visit 1. If none of the 4 quadrants qualify, 
the subject may remain in the study and have safety and cellulite severity evaluations 
performed at 3-month intervals but is not eligible for treatment. 
8. Subject will select an eligible quadrant (based on qualifying scores) to be treated at their 
discretion. 
9. Medical history including EFP history. Medical history will be based on EN3835-201 
eCRF; only updates to the history need to be captured at Screening B visit. 
10. Record prior and concomitant medications/procedures. Prior medications will be based 
on EN3835-201 eCRF; only updates and concomitant medications need to be captured at 
Screening B visit (section 12.2). 
11. Physical examination including measurement of body weight and height (section 14.10)  
12. Vital sign measurements (section 14.8) 
13. 12-lead electrocardiogram (ECG), not necessary if the date of the ECG obtained during 
the double-blind study (EN3835-201) is within 12 months of the date of the Screening B 
visit (section 14.9) 
14. Collection of samples for: 
a. Clinical laboratory testing (section 14.7) 
b. Urine pregnancy testing (section 14.7) 
15. Adverse events (section 14) 
12.1.4.2. Treatment Session 1 (Treatment Visit 1)  
Pre-injection 
1. Confirm eligibility criteria (section 11) 
2. Take digital photography of selected quadrant before dimple marking (section 13.1) 
3. Record concomitant medications/procedures (section 12.2) 
4. Vital sign measurements (section 14.8)  
5. Collection of samples for:  
a. anti-AUX-I and anti-AUX-II antibody testing (section 14.7.1) 
b. urine pregnancy testing (section 14.7) 
6. Select and mark dimples to be treated (section 12.1.4) 
7. Take digital photograph of selected quadrant after dimple marking (section 13.1) 
Injection 
Administration of study drug in the prone position (see below) 

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Post-injection 
1. Record number of dimples treated and number of injections administered 
2. Vital sign measurements (section 14.8) 
3. Injection site reactions and local tolerability 
4. Adverse events (section 14) 
The selected quadrant will be photographed before and after dimple marking while the subject is 
standing in a consistent relaxed pose as described in the Photography Manual. Before injection at 
treatment session 1, the Investigator or qualified designee will begin the session by selecting 
dimples within the chosen quadrant that are well defined, evident when the subject is standing, 
and suitable for treatment; treatment consists of up to 12 injections per session. Because the goal 
of treatment is to improve the aesthetic appearance of the entire quadrant, the Investigator will be 
instructed to select dimples that in his or her opinion would most improve the aesthetic 
appearance of the entire quadrant. The same dimples within a quadrant or different dimples 
within a quadrant may be treated at each session but injections must all be within the selected 
quadrant for all 3 sessions. 
For each dimple selected for treatment, the Investigator or qualified designee will choose 
injection sites (injection sites within a dimple should be spaced approximately 2 cm apart, if a 
dimple requires more than 1 injection). Each injection site will be marked with a “dot” using a 
surgical marker. For round dimples, the “dot” will be placed in the center of the dimple; for 
elongated dimples, “dots” will be spaced out approximately 2 cm along the longer axis of the 
dimple. The Investigator or qualified designee will then use a surgical marker to circle each of 
the dimples selected for treatment. Circles in the selected quadrant should not overlap.  
Examples of subject dimple marking: 
Sample Thigh Marking 
Sample Buttock Marking 

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The total number of dimples treated and the total number of injections administered will be 
recorded during treatment sessions 1, 2, and 3.  
NOTE: EN3835 is a foreign protein and Investigators must be prepared to address and manage 
an allergic reaction should it occur. At the time of each injection, a 1:1,000 solution of 
epinephrine for injection, 50-mg diphenhydramine injection or a suitable equivalent, and oxygen 
should be available and the Investigator and site staff must be familiar with their use.  
Care Procedures After Injection 
To evaluate the subject for possible immediate immunological AEs, the subject will remain in 
direct observation of medical personnel who are skilled in the management of an allergic 
reaction for 30 minutes after receiving the injection of study drug and until the subject exhibits 
no sign of an immunological or other clinically significant systemic or local AE. The subject’s 
vital signs should be stable before the subject can leave direct observation (see section 14.8).  
The Investigator or qualified designee will then apply a sterile dressing to the injection site with 
hypoallergenic tape. The subject will be instructed to remove the dressing in the evening.  
12.1.4.3. Treatment Session 2 (Treatment Visit 2/Day 22 ± 3 Days) and Treatment 
Session 3 (Treatment Visit 3/Day 43 ± 3 Days) 
Pre-injection 
1. Record concomitant medications/procedures (section 12.2) 
2. Body weight measurements  
3. Vital sign measurements (section 14.8)  
4. Collection of samples for urine pregnancy testing (section 14.7) 
5. Digital photograph of selected quadrant before dimple marking (section 13.1) 
6. Subject assessment of the severity of cellulite using photograph of the selected quadrant 
via PR-PCSS (section 13.1.1.1). NOTE: Complete the subject (PR-PCSS) assessment 
before the Investigator (CR-PCSS) assessment and before dimple marking. 
7. Investigator will conduct an independent live assessment of the severity of cellulite using 
the CR-PCSS (section 13.1.1.4). The investigator will conduct the assessment of severity 
only after the subject has completed her rating of her quadrant and without knowledge of 
the subject's rating of her quadrant. 
8. Selection and marking of dimples to be treated (section 12.1.4)  
9. Digital photograph after dimple marking (section 13.1)  
Injection 
Administration of study drug in the prone position (section 12.1.4.2) 

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Post-injection 
1. Record number of dimples treated and number of injections administered 
2. Vital sign measurements (section 14.8) 
3. Injection site reactions and local tolerability  
4. AEs (section 14) 
If the Investigator rates the selected quadrant as 0, no injections will be given. If no injections are 
given at treatment session 2, subjects will still return for the Day 43 visit and the selected 
quadrant will again be evaluated by the subject (PR-PCSS) and Investigator (CR-PCSS). If the 
Investigator rates the selected quadrant greater than 0 on the CR-PCSS, injections at treatment 
session 3 should be given. 
Because the goal of treatment is to improve the aesthetic appearance of the entire quadrant, the 
Investigator will be instructed to select dimples that in his or her opinion would most improve 
the aesthetic appearance of the entire quadrant. The same dimples within a quadrant or different 
dimples within a quadrant may be treated at each session but injections must all be within the 
selected quadrant for all 3 sessions. Each subject will receive all 3 treatment sessions unless the 
selected quadrant has no treatable EFP dimples and the Investigator rates the quadrant a score of 
0 on the CR-PCSS.  
After the dimples are selected, the Investigator or qualified designee will again mark each 
injection site with a “dot,” and circle each dimple (circles should not overlap).  
12.1.4.4. Day 71 (+5 Days) End of Treatment/Early Termination 
The following procedures will be performed on Day 71: 
1. Record concomitant medications/procedures (section 12.2) 
2. Measurement of body weight  
3. Vital sign measurements (section 14.8)  
4. Collection of samples for: 
a. Clinical laboratory testing (section 14.7) 
b. Anti-AUX-I and anti-AUX-II antibody testing (section 14.7.1)  
5. Digital photograph of selected quadrant (section 13.1)  
6. Subject cellulite assessments of the selected quadrant using the photographic image 
(NOTE: complete subject cellulite assessments before Investigator cellulite assessments) 
using: 
a. PR-PCSS assessment (section 13.1.1.1) 
b. S-GAIS (section 13.1.1.2) 
c. Subject satisfaction with cellulite treatment assessment (section 13.1.1.3) 
7. Investigator cellulite assessments of selected quadrant independently conducted; ie, with 
no knowledge of the subject's rating, using: 

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a. CR-PCSS live assessment of subject (section 13.1.1.4) 
b. Hexsel CSS assessment of live subject while subject is standing in a relaxed position 
(section 13.1.1.6) 
c. I-GAIS (section 13.1.1.5) 
8. Injection site reactions and local tolerability 
9. AEs (section 14) 
12.1.4.5. Follow-up Visits 
Following the Day 71 visit, the quadrant(s) treated with EN3835 in the open label study will be 
evaluated every 3 months from the first exposure to EN3835 following the schedule in Table 2. 
The first follow-up visit will be approximately 20 days after the Day 71 visit (ie approximately 
Day 90 after treatment session 1). Follow-up visits will continue until the study is terminated 
when at least 100 subjects have been assessed at 12 months after the first exposure to EN3835. 
12.2. 
Prior and Concomitant Medications and Procedures 
All medications (including over-the-counter medications) taken by the subject at screening 
visit 1 through the end of the study must be recorded. 
Additionally, any diagnostic, therapeutic or surgical procedures performed during the study 
period should be recorded including the date, indication for and description of the procedure.  
12.2.1. 
Prohibited Medications 
The following medications are prohibited for those subjects that elect to have treatment with 
study drug during the treatment phase of the study: anticoagulants (warfarin, heparin, direct 
thrombin inhibitors, Factor X inhibitors) and antiplatelet agents (aspirin >150 mg/day and P2Y12 
inhibitors, such as clopidogrel), which can cause additional bruising. However the use of aspirin 
DWDGRVHOHYHORIPJSHUGD\ZLOOEHSHUPLWWHGGXULQJWKHtreatment phase of the study. For 
those subjects in the observational-only phase of study, there are no prohibited medications. 
Table 5: 
Concomitant Medication Restrictions for Subjects During the Treatment 
Phase of Study 
Drug Class 
Restrictions 
Anticoagulants 
Subjects who elect treatment cannot take antiplatelet agents or 
DQWLFRDJXODQWVH[FHSWIRU mg aspirin daily) within 7 days before 
and after the dosing administration. 
12.2.2. 
Prohibited Procedures 
The treatments and procedures listed in exclusion criteria are prohibited during the study. 
12.3. 
Treatment Compliance 
All subjects who elect to have treatment will receive study drug administered by a clinician at the 
investigator’s site. 

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Accidental or intentional overdoses should be reported to the Sponsor/designee promptly (see 
section 14.6.2). 
12.4. 
Blinding and Randomization 
This study will be conducted as an open-label investigation; no blinding of assigned treatment 
will occur. 
12.5. 
End of Study 
The end of study is when 100 subjects complete the 1-year safety and cellulite severity 
evaluations. At the time of study termination, ongoing subjects receiving treatment will be 
followed through the Day 71 visit. The remaining enrolled subjects (in excess of the first 
100 subjects to complete 1 year) will undergo early termination procedures in accord with the 
Schedule of Events (section 5). 
 

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13. 
ASSESSMENT OF EFFICACY 
13.1. 
Primary Efficacy Measurements 
Although measures of efficacious drug effect (ie, durability of improvement) will be made 
during the observation phase before the study drug blind is broken in the double-blind study 
(EN3835-201), and thereafter to the end of study, emphasis is on the assessment of safety over 
12 months after exposure to EN3835. Cellulite severity assessments will be made at scheduled 
intervals for both observation-only subjects (not receiving EN3835) as well as subjects who 
choose re-dosing or re-treatment with EN3835. 
Digital Photography: Digital photography will be utilized to assess certain cellulite severity 
parameters at specific intervals (see Schedule of Events, Table 2) for subjects in the observation-
only group as well as those electing to be re-treated or re-dosed with EN3835. At the 
Screening B visit for subjects electing to receive re-dosing or re-treatment, the Investigator or 
qualified designee will photograph each quadrant using a Sponsor-supplied standardized digital 
camera. The subject will be standing for each photography session and will be wearing a 
standardized photographic garment as described in the Photography Manual. The Investigator or 
qualified designee will photograph the selected quadrant as follows: 
x Screening B (no dimple marking)  
x Before and after dimple marking (prior to injections) on Days 1, 22, and 43 of each 
treatment course 
x During the Day 71 visit (end of treatment phase/early termination) of each treatment 
course 
All photographs from this study are the property of Endo and may be utilized for clinical 
development, scientific communication, marketing, regulatory purposes, and/or legal 
applications as required/desired by Endo. 
13.1.1. 
Subject and Investigator Cellulite Assessments 
As in the double-blind parent study, Investigator cellulite assessments are independent of the 
subject assessments. Therefore, all subject cellulite assessments must be completed before the 
Investigator’s cellulite assessments are made. After both the subject’s and investigator’s 
assessments are completed, the subject’s assessments will be revealed and compared to the 
clinician’s assessments to determine eligible quadrants. If more than 1 quadrant is eligible, the 
subject will select one for treatment. 
13.1.1.1. Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) 
The PR-PCSS will be conducted for the purpose of assessing the severity of cellulite in the 
buttock or thigh; there are separate scales for buttocks or thighs. The scales are 5-level 
photonumeric scales developed specifically for patients and used by the subject to assess the 
severity of their cellulite in the quadrants by viewing digital images of each of their quadrants 
captured by photography at the visit; the ratings range from 0 (None) to 4 (Severe) with labels 
and descriptors to aid the subject in the assessments.  

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All subjects who enter the observation-only phase of the study will have the PR-PCSS evaluation 
at months 3, 6, 9, and 12. 
For subjects electing re-treatment or re-dosing after the study drug blind is broken in study 
EN3835-201, a Screening B visit (Baseline) within 14 days before dosing Day 1 will occur. 
Subjects will have digital photographs taken of all 4 quadrants as done in the double-blind trial 
for qualifying purposes. Subjects will then perform the PR-PCSS for both buttocks (Figure 1) 
and thighs (Figure 2) and will be reminded of their proper use (Appendix D).  
At the beginning of visits on Days 22, 43, and 71; digital photographs of the selected quadrant 
will be taken. If the buttock is the treated region, subjects will be given the PR-PCSS for the 
buttock to use to make their evaluation; if the thigh is the treated region, subjects will be given 
the PR-PCSS for the thigh to make their evaluation.  
 

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Figure 1: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the Buttock 
 

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Figure 2: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the Thigh 

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13.1.1.2. Subject Global Aesthetic Improvement Scale (S-GAIS) 
Subjects in the observation-only group will complete the S-GAIS as described below at the final 
study visit (month 12 or early termination) using the pre-treatment Day 1 image (Baseline) of the 
assigned quadrant in the double-blind study for comparison. 
For subjects who elected to receive EN3835 treatment, the S-GAIS assessment will be done on 
Day 71 of the treatment course and then at month 12 or the final study visit and compared back 
to the pre-dosing Screening B image (Baseline for treatment subjects) of the selected quadrant. 
All treated subjects will be instructed to answer the following question: How would you rate the 
appearance of your treated cellulite after treatment? 
The S-GAIS assessment will occur after the subject has completed the PR-PCSS assessment to 
avoid introducing potential bias to the static PR-PCSS assessment. Each subject will view the 
pre-dosing Screening B visit digital image alongside their Day 71 treatment course visit and 
month 12 or end of study visit digital image of their selected quadrant to aid in the assessment 
(Table 6). Subjects will circle the rating below that best represents their answer. 
Table 6: 
Subject Global Aesthetic Improvement Scale (S-GAIS) 
Rating 
Response Option 
Description 
+3 
Very much improved 
My treated cellulite looks very much better. 
+2 
Much improved 
My treated cellulite looks much better, but additional treatment 
would slightly improve the result. 
+1 
Improved 
My treated cellulite looks better, but additional treatment is 
necessary. 
0 
No change 
My treated cellulite looks essentially the same as it did 
originally. 
í1 
Worse 
My treated cellulite looks worse than it did originally. 
í2 
Much worse 
My treated cellulite looks much worse than it did originally. 
í3 
Very much worse 
My treated cellulite looks very much worse than it originally. 
13.1.1.3. Subject Satisfaction with Cellulite Treatment Assessment 
For observation-only subjects (not receiving EN3835) the subjects will assess their satisfaction 
with cellulite treatment at the 12 month or end of study visit by being instructed to answer the 
following question: Today, how satisfied are you with the results of the cellulite treatment you 
received on the specific area or areas on your buttocks or thighs that were treated? Subjects will 
circle the rating in the below table that best represents their answer. 
For subjects who have elected to receive EN3835 either through re-treatment or re-dosing, the 
subject satisfaction with the cellulite treatment (Table 7) with be done at the treatment course 
Day 71 and the month 12 visit or end of study visit. Subjects will be instructed to answer the 
following question: Today, how satisfied are you with the results of the cellulite treatment you 
received on the specific area or areas on your buttocks or thighs that were treated? Subjects will 
circle the rating below that best represents their answer. 

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Table 7: 
Subject Satisfaction with Cellulite Treatment Assessment 
Rating 
Description 
+2 
I am very satisfied with the cellulite treatment on my buttocks or thighs. 
+1 
I am satisfied with the cellulite treatment on my buttocks or thighs. 
0 
I am neither dissatisfied nor satisfied with the cellulite treatment on my buttocks or thighs. 
í1 
I am dissatisfied with the cellulite treatment on my buttocks or thighs. 
í2 
I am very dissatisfied with the cellulite treatment on my buttocks or thighs. 
13.1.1.4. Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 
The CR-PCSS will be conducted for the purpose of assessing the severity of cellulite in the 
buttock or thigh; there are separate scales for buttocks or thighs. The scales are 5-level 
photonumeric scales developed specifically for clinicians and used by the investigator to assess 
the severity of the subject’s cellulite in the quadrants by live assessments of the subject’s 
quadrant(s); the ratings range from 0 (None) to 4 (Severe) with labels and descriptors to aid the 
investigator in the assessments.  
Investigators will have been trained on the use of the CR-PCSS. For observation-only subjects, 
the CR-PCSS will be done at 3, 6, 9, and 12 months or at the end of study visit. 
For subjects who elected to receive EN3835 after the study drug blind is broken in study 
EN3835-201 as a re-treatment or re-dosing, the Investigator, at the Screening B visit (Baseline) 
will determine severity of cellulite of the 4 quadrants by assessing live subjects using the 
CR-PCSS for buttock (Figure 3) and thighs (Figure 4) after the subject has completed their self-
assessment using the PR-PCSS. The eligible quadrant chosen for injection will be at the 
discretion of the subject. Before injections on treatment visit Days 22 and 43 and on visit 
Day 71; Investigators will evaluate the selected quadrant by live assessments. If the buttock is 
the treated region, the Investigator will use the CR-PCSS for the buttock to make his/her 
evaluation; if the thigh is the treated region, the Investigator will use the CR-PCSS for the thigh 
to make his/her evaluation. In each case, the Investigator will make his/her assessment 
independently and after the subject has conducted their self-assessment using the PR-PCSS. 
 

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Figure 3: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for the Buttock 
 

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Figure 4: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for the Thigh 
 
 

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13.1.1.5. Investigator Global Aesthetic Improvement Scale (I-GAIS) 
Investigators will complete the I-GAIS on subjects in the observation-only group as described 
below at the final study visit (month 12 or early termination) and a comparison back to the pre-
treatment Day 1 (Baseline) image of the assigned quadrant of the double-blind study. 
On Day 71 of the treatment course and the 12 month or end of study visit, the Investigator will 
determine the degree of improvement from the Screening B digital image of the selected 
quadrant by comparing the cellulite in live assessment on Day 71 and at month 12 or study end 
to the Screening B pre-treatment (Baseline) image of the subject’s selected quadrant (Table 8). 
The I-GAIS assessment will occur after the CR-PCSS assessment (section 13.1.1.4) to avoid 
introducing potential bias to the static CR-PCSS assessment by the Investigator at the site. The 
Investigator will circle the rating below that best represents their answer. 
Table 8: 
Investigator Global Aesthetic Improvement Scale (I-GAIS) 
Rating 
Response Option 
Description 
+3 
Very much improved 
Optimal cosmetic result from treatment of the treated dimples 
+2 
Much improved 
Marked improvement in the treated area appearance from 
before treatment, but not completely optimal 
+1 
Improved 
Obvious improvement in the treated area appearance from 
before treatment, but additional treatment is indicated 
0 
No change 
The treated area appearance is essentially the same as before 
treatment 
í1 
Worse 
The treated area appearance is worse than before treatment 
í2 
Much worse 
Marked worsening in appearance from the initial condition 
í3 
Very much worse 
Obvious worsening in appearance from the initial condition 
13.1.1.6. Hexsel Cellulite Severity Scale 
The Hexsel Cellulite Severity Scale (referred to as the Hexsel CSS) is a photonumeric scale that 
looks at 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of 
depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or 
sagging of skin, and (E) current classification scale based on medical literature including 
Nürnberger and Müller.(12,13) Each of these features is evaluated on a 4-point scale from a low 
of 0 to a high of 3 as described in Table 9 (see Appendix B). The total score is the summation of 
all 5 features. 
For subjects in the observation-only group, the Hexsel CSS will be done at the month 12 or the 
end of study visit. 
For the subjects electing treatment (re-treatment or re-dosing) with EN3835 the Investigator or 
qualified designee will independently use the Hexsel CSS to assess the severity of EFP in all 
quadrants at Screening B visit and the selected quadrant on Day 71 of the course of treatment 
and at month 12 or end of study visit. All cellulite assessments should be made while the subject 
is in the standing position with relaxed gluteus muscles. However, when evaluating the subject 
for Category E (classification scale by Nürnberger and Müller) (13) if the subject has no evident 
depressions, the subject should be asked to contract her gluteus muscles or the pinch test should 

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be applied (by pinching the skin between the thumb and index finger) so the Investigator or 
qualified designee can differentiate between scores/grades of zero (0) or I. 
Table 9: 
Hexsel Cellulite Severity Scale 
A 
Number of evident depressions 
0=none/no depressions 
1=a small amount: 1-4 depressions are visible 
2=a moderate amount: 5-9 depressions are visible 
3=a large amount: 10 or more depressions are visible 
B 
Depth of depressions 
0=no depressions 
1=superficial depressions 
2=medium depth depressions 
3=deep depressions 
C 
Morphological appearance of skin 
surface alterations 
0=no raised areas 
1=‘orange peel’ appearance 
2=‘cottage cheese’ appearance 
3=‘mattress’ appearance 
D 
Grade of laxity, flaccidity, or sagging 
skin 
0=absence of laxity, flaccidity, or sagging skin 
1=slight draped appearance 
2=moderate draped appearance 
3=severe draped appearance 
E 
Classification scale by Nürnberger and 
Müllera 
0 = zero grade = Grade or Stage 0 = There is no alteration of the 
skin surface. 
1 = first grade = Grade or Stage I = The skin of the affected area 
is smooth while the subject is standing or lying, but the 
alterations to the skin surface can be seen by pinching the skin 
or with muscle contraction. 
2= second grade = Grade or Stage II = The orange skin or 
mattress appearance is evident when standing, without the use 
of any manipulation (skin pinching or muscle contraction). 
3= third grade = Grade or Stage III = The alterations described 
in Grade or Stage II, are present together with raised areas and 
nodules. 
Source: Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad 
Dermatol Venereol. 2009;23(5):523-528. 
a Subjects should be evaluated in the standing position with relaxed gluteus muscles. However, if the subject has no 
evident depressions, they should be asked to contract their gluteus muscles or the pinch test should be applied (by 
pinching the skin between the thumb and index finger) in order to differentiate between grade/stage of zero (0) 
or I. 
 

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14. 
ASSESSMENT OF SAFETY 
14.1. 
Definitions 
14.1.1. 
Adverse Event 
An adverse event (AE) is any unfavorable or unintended change in body structure (signs), body 
function (symptoms), laboratory result (eg, chemistry, ECG, X-ray, etc), or worsening of a pre-
existing condition associated temporally with the use of the study medication whether or not 
considered related to the study medication. AEs will be captured once a subject has signed the 
informed consent. AEs include: 
x Changes in the general condition of the subject 
x Subjective symptoms offered by or elicited from the subject 
x Objective signs observed by the Investigator or other study personnel 
x All concurrent diseases that occur after the start of the study, including any change in 
severity or frequency of pre-existing disease 
x All clinically relevant laboratory abnormalities or physical findings that occur during 
the study 
A treatment-emergent adverse event (TEAE) is any condition that was not present prior to 
treatment with study medication but appeared following treatment, was present at treatment 
initiation but worsened during treatment, or was present at treatment initiation but resolved and 
then reappeared while the individual was on treatment (regardless of the intensity of the AE 
when the treatment was initiated).  
All AEs, including both observed or volunteered problems, complaints, signs or symptoms must 
be recorded on the AE page of the eCRF, regardless of whether associated with the use of study 
medication. This would include AEs resulting from concurrent illness, reactions to concurrent 
medication use, or progression of disease states (excluding the disease under study). A condition 
present at baseline that worsens after initiation of study treatment will be captured as an AE; the 
onset date will be the date the event worsened. The AE should be recorded in standard medical 
terminology when possible. 
14.1.2. 
Serious Adverse Event 
A serious adverse event (SAE) is defined as an AE that: 
x Results in death 
x Is immediately life-threatening (there is an immediate risk of death from the AE as it 
occurred; this does not include an AE that had it occurred in a more serious form may 
have caused death) 
x Results in or prolongs an inpatient hospitalization (Note: a hospitalization for elective 
or pre-planned surgery, procedure, or drug therapy does not constitute an SAE)  

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x Results in permanent or substantial disability (permanent or substantial disruption of 
one’s ability to conduct normal life functions)  
x Is a congenital anomaly/birth defect (in offspring of a subject using the study 
medication regardless of time to diagnosis) 
x Is considered an important medical event 
Important medical events are defined as events that, based upon appropriate medical judgment, 
may jeopardize the subject and may require medical or surgical intervention to prevent one of the 
other serious outcomes. Examples of important medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions 
that do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse. 
14.2. 
Monitoring Adverse Events 
At each visit, subjects will be queried regarding any AEs that have occurred since the last visit. 
Subjects will be asked to volunteer information concerning AEs with a non-leading question 
such as, “How do you feel?” Study site personnel will then record all pertinent information in the 
source documents and the eCRF. The study drug compliance record should also be reviewed to 
detect potential overdoses (intentional/unintentional). 
14.3. 
Relationship to Study Drug 
The degree of “relatedness” of the AE to the study medication must be described using the 
following scale:  
x Not related indicates that the AE is definitely not related to the study medication. 
x Unlikely related indicates that there are other, more likely causes and study 
medication is not suspected as a cause. 
x Possibly related indicates that a direct cause and effect relationship between study 
medication and the AE has not been demonstrated, but there is evidence to suggest 
there is a reasonable possibility that the event was caused by the study medication. 
x Probably related indicates that there is evidence suggesting a direct cause and effect 
relationship between the AE and the study medication. 
It is the Sponsor’s policy to consider “Probably related” and “Possibly related” causality 
assessments as positive causality. “Not related” and “Unlikely related” causality assessments are 
considered as negative causality. 
Assessments will be recorded on the eCRF and must indicate clearly the relationship being 
assessed. For example, an AE that appears during a placebo run-in phase would be assessed with 
respect to the placebo treatment received and/or study procedures conducted during this phase. If 
the AE continued into an active treatment phase, the relationship would be assessed for the active 
treatment phase only if the AE worsened.  

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14.4. 
Intensity Assessment 
The intensity (or severity) of AEs is characterized as mild, moderate, or severe: 
x Mild AEs are usually transient, requiring no special treatment, and do not interfere 
with the subject’s daily activities. 
x Moderate AEs introduce a low level of inconvenience or concern to the subject and 
may interfere with daily activities, but are usually ameliorated by simple therapeutic 
measures. 
x Severe AEs interrupt a subject’s usual daily activity and typically require systemic 
drug therapy or other treatment. 
When the intensity category of an AE changes, the greatest intensity during that continuous 
episode should be recorded.  
14.5. 
Reporting Adverse Events and Serious Adverse Events 
14.5.1. 
Reporting Adverse Events 
Throughout the study, AEs will be documented on the source document and on the appropriate 
page of the eCRF whether or not considered treatment-related. This includes any new signs, 
symptoms, injury or illness, including increased severity of previously existing signs, symptoms, 
injury, or illness. Conditions existing prior to screening will be recorded as part of the subject’s 
medical history. The Investigator is responsible for assessing the relationship of AEs to the study 
medication; relationship will be classified as not related, unlikely related, possibly related, or 
probably related.  
All AEs will be collected by the Investigator from the time of signing the informed consent 
through 30 days after the last dose of study medication; this includes any AEs that are ongoing at 
the time of completion/termination of the study. All ongoing AEs must be followed until 
resolution or for 30 days after the subject’s last study visit, whichever comes first. 
14.5.2. 
Reporting Serious Adverse Events 
Any SAE, including death resulting from any cause, which occurs to any subject participating in 
this study must be reported via email or fax by the Investigator using the Endo Clinical Trial 
Report Form for SAEs within 24 hours of first becoming aware of the SAE. SAEs will be 
collected by the Investigator from the time of signing the informed consent through 30 days after 
the last dose of study medication. SAEs that occur within 30 days, following cessation of the 
study treatment, or within 30 days, following premature discontinuation from the study for any 
reason, must also be reported within the same timeframe. Any SAE that is felt by the Investigator 
to be related to the study medication must be reported regardless of the amount of time since the 
last dose received. Follow-up information collected for any initial report of an SAE must also be 
reported to the Sponsor within 24 hours of receipt by the Investigator.  
All SAEs will be followed until resolution, stabilization of condition, or until follow-up is no 
longer possible. 

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14.6.3. 
Pregnancy 
Any uncomplicated pregnancy that occurs in a subject during this clinical study will be reported 
for tracking purposes only. All subject pregnancies that are identified during or after this study, 
where the estimated date of conception is determined to have occurred during study drug therapy 
or within 30 days of the last dose of study medication need to be reported, followed to 
conclusion, and the outcome reported, even if the subject is discontinued from the study. The 
investigator should report all pregnancies within 24 hours using the Initial Pregnancy Report 
Form, and any pregnancy-associated SAE using the SAE report form, according to the usual 
timelines and directions for SAE reporting provided in section 14.5.2. Monitoring of the 
pregnancy should continue until conclusion of the pregnancy; 1 or more Follow-up Pregnancy 
Report Form(s) detailing progress, and a Two Month Follow-up Pregnancy Report Form 
detailing the outcome, should be submitted. 
Pregnancy itself is not regarded as an AE unless there is suspicion that the investigational 
product under study may have interfered with the effectiveness of a contraceptive medication. 
Likewise, elective abortions without complications are not considered AEs. Any SAEs 
associated with pregnancy (eg, congenital abnormalities/birth defects/spontaneous miscarriages 
or any other serious events) must additionally be reported as such using the SAE report form. 
Spontaneous miscarriages should also be reported and handled as SAEs.  
Subjects should be instructed to immediately notify the investigator of any pregnancies. 
Attempts to obtain the pregnancy follow-up and pregnancy outcome information detailed above 
are necessary even if a subject discontinues treatment because of pregnancy. 
14.6.4. 
Adverse Events/Serious Adverse Events Experienced by Non-subjects Exposed 
to Study Medication 
Non-subjects are persons who are not enrolled in the study but have been exposed to study 
medication, including instances of diversion of study medication. All such AEs/SAEs occurring 
in non-subjects from such exposure will be reported to the Endo Pharmacovigilance and Risk 
Management (PVRM) Department (when the non-subject agrees) on the departmental form for 
SAEs regardless of whether the event is serious or not. Instructions for completing the form for 
events experienced by non-subjects will be provided. SAEs occurring in non-subjects exposed to 
study medication will be processed within the same SAE reporting timelines as described in 
section 14.5.2, Serious Adverse Event Reporting. Additionally, the drug accountability source 
documentation at the site should reflect this occurrence. 
14.7. 
Clinical Laboratory and Immunogenicity Determinations 
Clinical laboratory tests will be conducted according to the Schedule of Events (section 5). 
Clinical laboratory tests will be performed by a designated central laboratory. Each site will be 
provided with instructions on specimen collection, preparation, packaging and transport. Refer to 
the central laboratory manual for further information regarding sample collection, handling, and 
labeling. The results of the tests will be returned to the investigational sites.  
Clinical laboratory test data will be reviewed by the investigator, or designee, and additional 
clinical laboratory tests may be ordered at his/her discretion (eg, if the results of any clinical 
laboratory test falls outside the reference range or clinical symptoms necessitate additional 

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testing to ensure safety). Any additional testing will be performed by the designated central 
laboratory. 
The investigator will review all abnormal lab results for clinical significance. Any abnormal 
clinical laboratory test result meeting the investigator’s or Sponsor’s criteria for clinical 
significance (refer to central laboratory manual) will be recorded as an AE or SAE as appropriate 
(see section 14.1.1, Adverse Events or section 14.1.2, Serious Adverse Events). 
Laboratory results will be sent electronically to Endo for data management. 
Clinical laboratory parameters that will be measured in this study are listed in Table 10. 
Table 10: 
Clinical Laboratory Parameters 
Hematology 
Clinical Chemistry 
Urinalysis 
Hematocrit 
Hemoglobin 
Red blood cell count 
Red blood cell morphology 
White blood cell count 
Neutrophils 
Lymphocytes 
Monocytes 
Basophils 
Eosinophils 
Platelets 
Blood urea nitrogen 
Creatinine 
Total bilirubin 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Alkaline phosphatase 
Sodium 
Potassium 
Calcium 
Chloride 
Phosphate 
Serum bicarbonate 
Uric acid 
Total cholesterol 
Total protein 
Glucose 
Triglycerides 
Albumin 
Specific gravity 
Ketones 
pH 
Protein 
Blood 
Glucose 
Female subjects of childbearing potential must have a negative urine pregnancy test at 
Screening B and at treatment visits 1, 2, and 3 (section 5) to receive treatment in the study. If 
necessary, additional urine pregnancy tests can be performed at any time during the study at the 
discretion of the Investigator.  
14.7.1. 
Anti-AUX-I and Anti-AUX-II Antibodies 
Serum samples will be collected and may be tested for binding and neutralizing anti-AUX-I and 
anti-AUX-II antibodies at visit 1 and visit 4. Additionally, if a subject consents to treatment in 
the open-label study, serum samples for antibody testing will be collected before injection at 
treatment visit 1 and at end of treatment/ early termination visit 4 of the open-label treatment 
period. A subset of subject samples may have neutralizing antibodies tested from Day 1 and 
Day 71 visits; additional samples may be analyzed if results or clinical signs warrant testing.  
The serum samples obtained will be processed, stored and then shipped on dry ice to the 
designated central clinical laboratory before forwarding to Endo’s appointed laboratory for the 
determination of anti-AUX-I and anti-AUX-II antibodies according to the Laboratory Manual.  

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14.8. 
Vital Signs 
Vital sign measurements will be documented as described in the Schedule of Events. These 
parameters include pulse rate, respiratory rate, systolic and diastolic blood pressure, and body 
temperature. Pulse and blood pressure readings will be taken after the subject has been sitting for 
5 minutes. Height should only be recorded at Screening B.  
The investigator will review all vital sign values for clinical significance. Any vital sign value 
meeting the investigator’s or Sponsor’s criteria for clinical significance will be recorded as an 
AE or SAE as appropriate (see section 14.1.1, Adverse Events, and section 14.1.2, Serious 
Adverse Events). 
For subjects receiving treatment, vital signs will be assessed at the time points shown in Table 11 
after the subject has rested for at least 5 minutes.  
Table 11: 
Vital Signs Measurements on Injection Day 
Time Point Relative to Last Injection 
Blood Pressure, Respiratory 
Rate, and Pulse Rate 
Body Temperature 
Up to 4 hours (before treatment) 
X 
X 
Approximately 15 minutes after 
X 
 
Approximately 30 minutes after 
X 
X 
14.9. 
Electrocardiogram 
Performing a 12-lead electrocardiogram (ECG) is not necessary if Screening B visit date is 
within 12 months of obtaining an ECG during the double-blind study (EN3835-201).  
If the date of Screening B visit is later than 12 months since obtaining the ECG in study 
EN3835-201, subjects will have a resting 12-lead ECG performed during the Screening B visit. 
A qualified physician will interpret, sign, and date the ECGs. Electrocardiogram assessments 
must be “within normal limits” or interpreted as “abnormal, not clinically significant” for the 
subject to be included in the study. 
Any ECG result meeting the investigator’s or Sponsor’s criteria for clinical significance will be 
recorded as an AE or SAE as appropriate (see section 14.1.1, Adverse Events and section 14.1.2, 
Serious Adverse Events). 
14.10. 
Physical Examination 
Body weight will be collected as described in the Schedule of Events (section 5). If a subject 
desires treatment in the open-label study, a complete physical examination will be performed at 
Screening B. All examinations will be performed by a physician or health professional listed on 
the Form FDA 1572 and licensed to perform physical examinations. 
The investigator will review all physical exam findings for clinical significance. Any physical 
exam finding meeting the investigator’s or Sponsor’s criteria for clinical significance will be 
recorded as an AE or SAE as appropriate (see section 14.1.1, Adverse Events and section 14.1.2, 
Serious Adverse Events). 

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14.11. 
Other Safety Assessments 
Not applicable. 

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15. 
ASSESSMENT OF PHARMACOKINETICS 
Not applicable. 

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16. 
ASSESSMENT OF PHARMACODYNAMICS 
Not applicable. 

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17. 
STATISTICAL CONSIDERATIONS AND METHODS 
17.1. 
Determination of Sample Size 
It is estimated that approximately 95% of the 350 subjects randomized in study EN3835-201 will 
enroll in the current study for a sample size of 333. This sample size should be adequate to 
determine safety and cellulite assessments of EN3835 for subjects retreated in the same and in 
different quadrants. 
17.2. 
Subject Cohorts and Subject Populations 
Subjects will be classified into 1 of 4 different cohorts depending on where they receive the 
treatment of EN3835 in relation to where they received treatment in study EN3835-201. The 
4 cohorts are: 
1. Observational subjects only - subjects who received EN3835 in study EN3835-201 but do 
not receive any injections in the current study 
2. Re-treatment subjects - subjects who received EN3835 in study EN3835-201 and receive 
EN3835 in the current study in the same quadrant that was treated in the EN3835-201 
study. This will only be allowed for subjects who have baseline severity ratings in the 
current study at or worse than the baseline seen in study EN3835-201 for both the 
CR-PCSS and PR-PCSS of the quadrant.  
3. Re-dosing subjects - subjects who received EN3835 in study EN3835-201 and receive 
EN3835 in the current study in a quadrant different than the EN3835-treated quadrant in 
study EN3835-201. 
4. Initial treatment subjects - subjects who received placebo in study EN3835-201 and 
receive EN3835 in the current study. 
All efficacy and safety analyses will be done within the classified cohort. Durability of treatment 
effects defined as the time from onset of change from baseline of PR-PCSS and CR-PCSS in the 
quadrant treated in study EN3835-201 until the time that the treated quadrant return to baseline 
cellulite severity ratings of PR-PCSS and CR-PCSS in an EN3835-treated quadrant will be 
determined for all subjects that were treated with EN3835 in either this study or study 
EN3835-201. 
17.2.1. 
Observational Population 
The Observational population includes all subjects treated with EN3835 in study EN3835-201 
who do not receive any treatment in the current study. The durability of a treatment effect and 
long-term safety analyses for subjects who receive no treatment in the EN3835-201 study will be 
performed using this population 
17.2.2. 
Safety Population 
The Safety population will include all subjects who receive at least 1 dose of EN3835 in the 
current study or in study EN3835-201. All safety analyses will be performed using this 
population. 

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17.2.3. 
Intent-to-Treat Population 
The Intent-to-Treat (ITT) population includes all subjects who enroll in the current study.  
17.2.4. 
Modified Intent-to-Treat Population 
The Modified Intent-to-Treat (mITT) population includes all subjects who receive at least 1 dose 
of EN3835 in the current study (EN3835-202) and have a baseline and at least 1 post-baseline 
assessment on both the CR-PCSS and PR-PCSS on the quadrant selected for treatment in the 
current study. All cellulite assessment analyses will be completed on this population. 
17.2.5. 
Per-Protocol Population 
The Per-Protocol population includes all subjects in the safety population who have no major 
protocol deviations. Major protocol deviations excluding subjects from this population will be 
determined at the protocol deviation assessment meeting prior to the database lock. If more than 
10% of the safety population is excluded from the per-protocol population, then all safety and 
cellulite evaluations will be repeated using the per-protocol population. 
17.3. 
Subject Disposition 
The number of subjects included in each study population will be summarized. The number and 
percentage of subjects completed and discontinued will be presented. Reasons for 
discontinuation as recorded on the eCRF will be summarized (number and percentage) for all 
subjects. 
17.4. 
Demographics and Other Baseline Characteristics 
Demographic and baseline characteristics, including age, race, and baseline values will be 
summarized for the Observational population, the Safety population, and the mITT population 
using descriptive statistics. The descriptive statistics will include frequency tables for all 
categorical response variables and number, mean, standard deviation, minimum, and maximum 
for all continuous variables.  
17.5. 
Efficacy Analyses 
Cellulite assessments (efficacy) include: 
x PR-PCSS: 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) (screening 
visit [Baseline], Days 22, 43, and 71). Also will be done at Day 90, Day 180, 
Day 270, and Day 360/end of study visits for observational assessments. 
x CR-PCSS: 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) (screening 
[Baseline], Days 22, 43, and 71). Also will be done at Day 90, Day 180, Day 270, and 
Day 360/end of study visits for observational assessments. 
x Investigator rating of cellulite severity using the total scores from the Hexsel CSS 
scale: scores can range from 0 to 15 (screening [Baseline] and Day 71). Also will be 
done at Day 360/end of study visits for observational assessments. 

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x I-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) 
(Day 71). Also will be done at Day 360/end of study visit for observational 
assessments. 
x S-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much 
worse) (Day 71). Also will be done at Day 360/end of study visit for observational 
assessments. 
x Subject satisfaction with cellulite treatment assessment: 5-point scale ranging from 
+2 (very much satisfied) to í2 (very much dissatisfied) (Day 71). Also will be done at 
Day 360/end of study visit for observational assessments. 
All cellulite assessments will be done by treated quadrant. For initial treatment subjects who 
have 2 quadrants treated, each quadrant will be evaluated separately. 
17.5.1. 
Primary Efficacy Analysis 
The primary cellulite severity endpoint is the proportion of composite responders at Day 71 
defined as subjects with an improvement in severity from baseline (Screening B visit) of at least 
2 levels of severity in the CR-PCSS and an improvement in severity from baseline of at least 
2 levels of severity in the PR-PCSS. 
The primary endpoint, the proportion of composite responders with improvement of 2 or better 
on each scale (CR-PCSS and PR-PCSS) will be summarized by region treated (buttock or thigh) 
and overall with percentages. 
17.5.2. 
Secondary Efficacy Analysis 
Secondary endpoints for treated quadrants include: 
x Proportion of composite responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the CR-PCSS and an 
improvement of severity from baseline of at least 1 level of severity in the PR-PCSS. 
(Day 71) 
x Proportion at each level of improvement in the PR-PCSS (Day 71): 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels of severity in the PR-PCSS 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the PR-PCSS 
x Proportion at each level of improvement in the CR-PCSS (Day 71): 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels of severity in the CR-PCSS (Investigator 
rated) 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the CR-PCSS (Investigator 
rated) 

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x Proportion of responders at each level of the I-GAIS (Day 71): 
 Proportion of Investigator global responders defined as subjects with a response 
of 1 (improved) or better in the Investigator GAIS assessment 
x Proportion of responders at each level of the S-GAIS (Day 71): 
 Proportion of subject global responders defined as subjects with a response of 
1 (improved) or better in the subject GAIS assessment 
x Proportion of responders at each level of the subject satisfaction with cellulite 
treatment (Day 71) 
x Change in the Hexsel CSS total score from screening visit to Day 71 
x All secondary endpoints, except the Hexsel CSS total score, will be summarized by 
treated region (buttock or thigh) and overall using percentages. Change in Hexsel 
CSS total score will be summarized by treated region (buttock or thigh) and overall 
with descriptive statistics for continuous variables. 
Observational endpoints include: 
x Proportion of 2-point composite responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point composite responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 2-point CR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point CR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 2-point PR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point PR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 

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x Duration of response as defined by the time from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant treated in study EN3835-201 until the time 
that the treated quadrant returned to the baseline PR-PCSS and CR-PCSS ratings 
from study EN3835-201. 
x CR-PCSS change from the study EN3835-201 baseline at Day 71 of study 
EN3835-201, and Days 90, 180, 270, and 360/end of study of the current study 
(EN3835-202). 
x PR-PCSS change from the study EN3835-201 baseline at Day 71 of study 
EN3835-201, and Days 90, 180, 270, and 360/end of study of the current study 
(EN3835-202). 
x Hexsel CSS total score changed from the study EN3835-201 baseline at Day 71 of 
study EN3835-201 and Day 360/end of study of the current study (EN3835-202).  
x Proportion of responses at each level of the I-GAIS (Day 360/end of study): 
 Proportion of Investigator global responders defined as subjects with a response 
of 1 (improved) or better in the Investigator GAIS assessment 
 Change in I-GAIS assessment from Day 71 of study EN3835-201 and Day 360/ 
end of study of the current study (EN3835-202 
x Proportion of responses at each level of the S-GAIS (Day 360/end of study): 
 Proportion of subject global responders defined as subjects with a response of 
1 (improved) or better in the subject GAIS assessment 
 Change in S-GAIS assessment from Day 71 of study EN3835-201 and Day 360/ 
end of study of the current study (EN3835-202) 
x Proportion of responses at each level of the subject satisfaction with cellulite 
treatment (Day 360/end of study) 
 Change in subject satisfaction assessment from Day 71 of study EN3835-201 and 
Day 360/end of study of the current study (EN3835-202) 
For quadrants treated in the current study the following observational endpoints will be analyzed: 
x Proportion of 2-point composite responders as defined by the responses in the 
quadrant treated in this current study (EN3835-202) who either maintained response, 
lost response but did not return to the study EN3835-202 baseline, or returned to the 
study EN3835-202 baseline. 
x Proportion of 1-point composite responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 2-point CR-PCSS responders as defined by the responses in the 
quadrant treated in this current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 

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x Proportion of 1-point CR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 2-point PR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 1-point PR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x CR-PCSS change from the study EN3835-202 baseline at Day 71, Day 90, Day 180, 
Day 270, and Day 360/end of study. 
x PR-PCSS change from the study EN3835-202 baseline at Day 71, Day 90, Day 180, 
Day 270, and Day 360/end of study. 
x Duration of response as defined by the time from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant treated in the current study until the time that 
the treated quadrant returned to the baseline PR-PCSS and CR-PCSS ratings from 
study EN3835-202. 
17.6. 
Safety Analyses 
The following variables are safety endpoints. 
x AEs: Mapped to preferred term using the Medical Dictionary for Regulatory 
Activities (MedDRA) 
x Injection site reactions/local tolerability in selected quadrant (through subject and 
Investigator reporting) 
x Vital signs 
x Laboratory testing 
AEs will be summarized by treatment group. AE duration will be summarized using descriptive 
statistics by treatment group. 
Descriptive statistics will be presented for each clinical laboratory test for the actual and change 
from screening at each visit by treatment group and vital signs for the actual and change from 
Day 1 pre-injection for each injection day at each visit by treatment group. 
17.6.1. 
Prior, Concomitant, and Follow-up Medication 
The World Health Organization (WHO) Drug Dictionary will be used to classify prior and 
concomitant medications by therapeutic class. The version used in this study will be stated in the 
Data Management Plan. Prior medication will be defined as any medication with a start date 
prior to the Day 1 date. Concomitant medication is defined as any medication with a start date on 

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or after the Day 1 date or reported as ongoing. Any medications started after the last dose of 
study drug will be considered as follow-up medications 
Prior and concomitant medication use will be summarized descriptively by the number and 
percentage of subjects receiving each medication within each therapeutic class. Multiple use of 
the same medication by a subject will be counted only once. 
17.6.2. 
Study Drug Exposure 
For those subjects that elect, are eligible, and do receive treatment, the number of injections will 
be summarized by counts and percentages. The number of dimples treated will be summarized 
with counts and percentages.  
17.6.3. 
Measurement of Treatment Compliance 
All doses are administered while the subjects are at the investigators’ sites. Any dose that was 
not administered per protocol will recorded as a protocol deviation by the Investigator. 
17.6.4. 
Adverse Events 
The MedDRA will be used to code AEs. The version used in this study will be stated in the Data 
Management Plan. 
An AE (classified by preferred term) that started during the treatment period will be considered a 
TEAE if it was not present prior to the first dose of study drug, or was present prior to the first 
dose of study drug but increased in intensity during the treatment period. If more than 1 AE is 
reported prior to the first dose of study drug and coded to the same preferred term, then the AE 
with the greatest intensity will be used as the benchmark for comparison to the AEs occurring 
during the treatment period which were also coded to that preferred term. Any AE present prior 
to the first dose of study drug that increases in intensity during the treatment period will be 
re-entered with a new start date of the date of increased intensity.  
Descriptive statistics (the number and percentage) for subjects reporting TEAEs in each 
treatment group will be tabulated by system organ class and preferred term; by system organ 
class, preferred term, and severity; and by system organ class, preferred term, and relationship to 
study drug. If more than 1 AE is coded to the same preferred term for the same subject, the 
subject will be counted only once for that preferred term using the most severe and most related 
occurrence for the summarization by severity and by relationship to the study drug. 
SAEs and AEs leading to premature discontinuation of study drug will be summarized by 
preferred term and dose received. Listings will be presented for subjects with SAEs, subjects 
with AEs leading to discontinuation, and subjects who die (if any). 
17.6.5. 
Vital Signs 
Descriptive statistics for vital signs (eg, systolic and diastolic blood pressure, pulse rate, and 
body weight) and their changes from baseline at each visit and at the end of treatment visit will 
be presented.  

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Vital sign values are potentially clinically significant (PCS) if they meet both the observed value 
criteria and the change from baseline criteria. The criteria for PCS vital sign values will be 
detailed in the Statistical Analysis Plan (SAP). A listing of all AEs for subjects with PCS vital 
signs will also be provided. 
17.6.6. 
Clinical Laboratory Parameters 
Descriptive statistics for clinical laboratory values in International System of Units (SI units) and 
changes from baseline will be presented for each clinical laboratory parameter. 
The number and percentage of subjects with PCS post-baseline clinical laboratory values will be 
tabulated. The criteria for PCS laboratory values will be detailed in the SAP. A listing of all AEs 
for subjects with PCS laboratory values will also be provided. 
17.7. 
Immunogenicity Analyses 
Immunogenicity variables include anti-AUX-I/anti-AUX-II binding antibody results. Binding 
antibody levels will be determined from samples collected on Days 1, 22, 43, and 71 during the 
treatment phase and Days 90, 180, 270 and 360 during the observational phase. 
Descriptive statistics (percent of positive measurements and average antibody level) will be 
presented for anti-AUX-I and anti-AUX-II antibody levels at each time point by region treated 
and overall. Average antibody levels will be summarized on logarithmically transposed titer 
values. 
17.8. 
Pharmacokinetic Analyses 
Not applicable. 
17.9. 
Interim Analysis 
Two (2) interim analyses are planned. Following the breaking of the study drug blind in study 
EN3835-201, all follow-up safety data gathered prior to that time will be analyzed. The second 
interim analyses will occur following the Day 71 visit for all subjects treated with EN3835 in the 
current study. A preliminary data lock will be done on all treated quadrants and cellulite 
assessment and safety analyses will be done. The official database lock will occur after the last 
Day 360/end of study observational visit and all observational analyses on treated quadrants will 
be done. 
17.10. 
Statistical Software 
Statistical analyses will be performed using Version 9.3 (or higher) of SAS® (SAS Institute, 
Cary, North Carolina). 

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accountability during monitoring visits. When instructed by Endo, the Investigator agrees to 
return all original containers of unused study drug to Endo or its designee. 
18.5.1. 
Study Drug Handling and Disposal 
The Investigator is responsible for recording the receipt and use of all drug supplied and for 
ensuring the supervision of the storage and allocation of these supplies. All unused study drug 
will be returned, and unit counts will be performed whenever medication is returned. The site 
must account for all study drug received. The Investigator agrees not to supply study drug to any 
person except to those subjects enrolled in the study. At the end of the study, all unused drug 
supplies will be returned to Endo as instructed by the clinical monitor. 

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19.
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS
19.1. 
Source Documents 
Source documents include but are not limited to original documents, data and records such as 
hospital/ medical records (including electronic health records), clinic charts, lab results, subject 
diaries, data recorded in automated instruments, microfilm or magnetic media, and pharmacy 
records, etc. At a minimum, all data required to be collected by the protocol should have 
supporting source documentation for entries in the eCRF, unless the protocol specifies that data 
can be recorded directly on/in the eCRF or other device. 
19.2. 
Study Monitoring 
A representative of Endo Pharmaceuticals Inc. will meet with the Investigator and his/her staff 
prior to the entrance of the first subject to review study procedures and methods of recording 
findings in the eCRF.  
After enrollment of the first subject, an Endo Pharmaceuticals Inc. representative will be 
assigned to periodically monitor each Investigator site for study progress and to verify that 
standards of Good Clinical Practice (GCP) were followed. The Investigator is expected to 
prepare for the monitor visit, ensuring that all source documents, completed eCRFs, signed 
consent forms, and other study related documents are readily available for review. 
19.3. 
Audits and Inspections 
The Investigator shall permit audits and inspections by the Sponsor, its representatives and 
members of regulatory agencies. The investigator should immediately notify the Sponsor of an 
upcoming FDA or other regulatory agency inspection. 
19.4. 
Institutional Review Board (IRB) 
The Investigator shall permit members of the IRB/IEC to have direct access to source 
documents. 
19.5. 
Data Recording and Documentation 
All data recordings and source documentation (including electronic health records) must be made 
available to the Sponsor (or designee), FDA and any other regulatory agencies that request 
access to study records, including source documents, for inspection and copying, in keeping with 
federal and local regulations. 

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20.
QUALITY CONTROL AND QUALITY ASSURANCE
Steps to assure the accuracy and reliability of data include the selection of qualified principal 
investigators and appropriate study centers, review of protocol procedures with the principal 
investigators and associated personnel prior to start of the study, and periodic monitoring visits 
conducted by the Sponsor or Sponsor representative. Significant and/or repeated non-compliance 
will be investigated and remedial action instituted when appropriate. Failure to comply with 
remedial actions may result in investigator site termination and regulatory authority notification. 
The Sponsor or its designee will utilize qualified monitors to review and evaluate activities 
conducted at Investigator Sites. 
The data will be entered into the clinical study database and verified for accuracy, following 
procedures defined by the Sponsor (or designee). Data will be processed and analyzed following 
procedures defined by the Sponsor (or designee). 
The study will be monitored and/or audited at intervals to ensure that the clinical study is 
conducted and data are generated, documented (recorded), and reported in compliance with the 
Study Protocol; International Conference on Harmonisation (ICH), E6 consolidated guidelines; 
and other applicable regulations. The extent, nature, and frequency of monitoring and/or audits 
will be based on such considerations as the study objectives and/or endpoints, the purpose of the 
study, study design complexity, and enrollment rate. At the conclusion of a program, a 
compliance statement will be generated by the Sponsor (or designee) listing all audit activities 
performed during the clinical study. 

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21. 
ETHICS 
21.1. 
Ethics Review 
Approval by the IRB/IEC prior to the start of the study will be the responsibility of the 
Investigator. A copy of approval documentation will be supplied to Endo Pharmaceuticals Inc. 
along with a roster of IRB members that demonstrates appropriate composition (a Department of 
Health and Human Services [DHHS] Assurance Number will satisfy this requirement).  
The study protocol, the informed consent form, advertisements, materials being provided to 
subjects and amendments (if any) will be approved to IRB/IECs at each study center in 
conformance with ICH E6, the Code of Federal Regulations (CFR), Title 21, Part 56 and any 
other applicable local laws. The Investigator is responsible for supplying the IRB/IEC with a 
copy of the current IB, Package Insert, or SPC as well as any updates issued during the study. 
During the course of the study, the Investigator will provide timely and accurate reports to the 
IRB/IEC on the progress of the study, at intervals not exceeding 1 year (or as appropriate), and 
will notify the IRB/IEC of SAEs or other significant safety findings, per the policy of the 
IRB/IEC. At the conclusion of the study, the Investigator will submit a final report or close out 
report to the IRB/IEC and provide a copy to Endo Pharmaceuticals Inc. 
Any amendment to this protocol will be provided to the Investigator in writing by Endo 
Pharmaceuticals Inc. No protocol amendment may be implemented (with the exceptions noted 
below) before it has been approved by the IRB and the signature page, signed by the 
Investigator, has been received by Endo Pharmaceuticals Inc. Where the protocol is amended to 
eliminate or reduce the risk to the subject, the amendment may be implemented before IRB 
review and approval. However, the IRB must be informed in writing of such an amendment and 
approval obtained within reasonable time limits. Deviating from the protocol is permitted only if 
absolutely necessary for the safety or clinical management of the subject, and must be 
immediately reported to Endo Pharmaceuticals Inc.  
The Investigator will be responsible for supplying updated safety and/or study information to 
study subjects as it becomes available. 
21.2. 
Ethical Conduct of the Study 
This clinical study is designed to comply with the ICH Guidance on General Considerations for 
Clinical Trials (62 FR 6611, December 17, 1997), Nonclinical Safety Studies for the Conduct of 
Human Clinical Trials for Pharmaceuticals (62 FR 62922, November 25, 1997), Good Clinical 
Practice: Consolidated Guidance (62 FR 25692, May 9, 1997) and 21 CFR parts 50, 54, 56, and 
312. 
The study will be conducted in full compliance with ICH E6, the FDA guidelines for GCP and in 
accordance with the ethical principles that have their origins in the Declaration of Helsinki 
defined in 21 CFR, 312.120. 

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21.3. 
Subject Information and Consent 
Subjects, after having the study explained to them and an opportunity to have their questions 
answered sufficiently, will give voluntary and written informed consent (in compliance with ICH 
E6, 4.8 and 21 CFR Parts 50 and 312) before participating in any study-related procedures. The 
consent shall be written in a language understandable to the subject. Subjects unable to read 
(illiterate) shall have the consent process performed in the presence of an independent witness 
who shall also sign the consent. Each subject will read, assent understanding, and sign an 
instrument of informed consent after having had an opportunity to discuss the study and consent 
documents with the Investigator before signing, and will be made aware that she may withdraw 
from the study at any time.  
In addition to obtaining informed consent, the Investigator is responsible for obtaining any 
additional documentation to demonstrate compliance with local privacy laws applicable to 
activities performed.  
The consent process shall be recorded in source documents. Signed copies of the informed 
consent will be given to the Subject and originals will be placed in the Investigator study files.  
A unique Subject identification number will be assigned according to section 12.1.3 at the time 
that the Subject signs the informed consent form. 
 

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22. 
DATA HANDLING AND RECORDINGKEEPING 
22.1. 
Data Collection 
Data collection will involve the use of an EDC system to which only authorized personnel will 
have access. The system will be secured to prevent unauthorized access to the data or the system. 
This will include the requirement for a user ID and password to enter or change data. The level 
of access to the EDC system will be dependent on the person’s role in the study. 
Study data will be collected from source documents and entered into an eCRF within the EDC 
system. The Investigator will be responsible for ensuring the eCRFs are completed in a timely 
manner relative to the subject’s visit. In addition to periodic monitoring occurring within the 
system by a Sponsor monitor, programmatic edit checks will be used to review EDC data for 
completeness, logic, and adherence to the study protocol. As a result of this monitoring and these 
checks, queries may be issued electronically to the clinical study sites and closed electronically 
by the monitor, data management staff or authorized staff at the study site. Additionally, the 
Investigator will review eCRFs, ensure all missing or corrected data is provided and will sign the 
eCRF pages with an electronic signature.  
An electronic audit trail will be maintained in the EDC system to track all changes made to data 
entered in the eCRF. Data will be retrievable in such a fashion that all information regarding 
each individual subject is attributable to that subject. Unless otherwise indicated, all data 
captured in the eCRF must first be captured in source documents. Data that can be directly 
recorded in the eCRF will be clearly identified in the section(s) of the protocol that describes the 
assessment(s). 
In addition, any contact with the subject via telephone or other means that provide significant 
clinical information must be documented in source documents as described above. 
22.2. 
Study Documentation 
Upon study completion, the Investigator will be provided with complete electronic copies of the 
CRF data for his/her files.  
 

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23. 
REPORTING AND PUBLICATION 
All data generated in this study are the property of Endo. An integrated clinical and statistical 
report will be prepared at the completion of the study. 
Publication of the results by the Investigator will be subject to mutual agreement between the 
Investigator and Endo. 

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24. 
INVESTIGATOR OBLIGATIONS 
24.1. 
Regulatory Documents 
The Investigator is responsible for creating and/or maintaining all study documentation required 
by 21CFR 50, 54, 56 and 312, ICH, E6 section 8, as well as any other documentation defined in 
the protocol or the Investigator Agreement. The Investigator must maintain the documentation 
relating to this study and permit Endo Pharmaceuticals Inc. or a member of a regulatory agency 
access to such records. 
The Investigator must provide the following key documents to Endo Pharmaceuticals Inc. prior 
to the start of the study: 
x A completed and signed Form FDA1572. If during the course of the study any 
information reported on the Form FDA 1572 changes, a revised Form FDA1572 must 
be completed and returned to Endo Pharmaceuticals Inc. for submission to the FDA. 
For studies executed outside the United States, documentation required by the 
governing regulatory authority may be substituted for the Form FDA 1572. 
x A fully executed contract 
x The Investigator’s Statement page in this protocol signed and dated by the 
Investigator and any subsequent amendment signature pages 
x The IB acknowledgment of receipt page 
x Curricula vitae for the Principal Investigator and all Sub-Investigators listed on Form 
FDA 1572, including a copy of each physician’s license (if applicable) 
x A copy of the original IRB/IEC approval for conducting the study. If the study is 
ongoing, renewals must be submitted at yearly intervals or shorter intervals defined 
by the IRB/IEC. All subsequent modifications must be submitted and approved by the 
IRB, as described in section 21.1  
x A copy of the IRB/IEC-approved informed consent form 
x A list of IRB/IEC members or DHHS Assurance Number 
x Laboratory certifications and normal ranges (if local labs are required by the protocol) 
x A financial disclosure agreement completed and signed by the Investigator and all 
Sub-Investigators listed on Form FDA 1572. Investigator site staff that submitted an 
initial financial disclosure are also responsible for informing Endo Pharmaceuticals 
Inc. of any changes to their initial financial disclosure form 1 year after the 
completion of the study. 
A complete list of required regulatory documents will be supplied by Endo Pharmaceuticals Inc. 
or its representative. 

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24.2. 
Delegation of Responsibilities and Adequate Resources 
The Investigator should have adequate time to conduct the study properly and should have an 
adequate number of qualified staff to assist with the conduct of the study. The Investigator shall 
delegate tasks only to individuals qualified by education, training and experience to perform the 
delegated tasks. The Investigator shall have direct oversight of all delegated activities and shall 
document delegation of responsibilities. The Investigator is responsible for ensuring all delegated 
staff have been properly trained on the protocol and their assigned study responsibilities. 
24.3. 
Medical Care of Study Subjects 
The Investigator and/or a qualified sub-investigator shall be responsible for the subjects’ medical 
care. Any unrelated medical condition discovered during the course of the study should be 
communicated to the subject so that they may seek appropriate medical care. The Investigator 
will report all AEs as required by the protocol (section 14.5). The Investigator will inform study 
subjects of new information regarding the study drug as it becomes available. 
24.4. 
Use of Investigational Materials 
The Investigator will acknowledge that the study drug supplies are investigational and as such 
must be used strictly in accordance with the protocol and only under the supervision of the 
Principal Investigator or Sub-Investigators listed on Form FDA1572 (or other regulatory 
document, depending on region). Study drug must be stored in a safe and secure location. At 
study initiation, a representative from Endo Pharmaceuticals Inc. will inventory the study drug at 
the site. The Investigator must maintain adequate records documenting the receipt and 
disposition of all study supplies. Endo Pharmaceuticals Inc. or its representative will supply 
forms to document total inventory as well as subject specific accountability. The Investigator is 
responsible for monitoring use of the study drug to ensure compliance with the protocol. All 
study supplies shall be returned to Endo Pharmaceuticals Inc. or its designee.  
24.5. 
Retention of Records 
Federal and local regulations require that the Investigator retain a copy of all regulatory 
documents and records that support the data for this study (eg, informed consents, laboratory 
reports, source documents, study drug dispensing records) for whichever of the following is the 
longest period of time: 
x A period of 2 years following the final date of approval by the FDA or other 
regulatory agency of the study drug for the purposes that were the subject of the 
investigation; or 
x A period of 5 years following the date on which the results of the investigation were 
submitted to the FDA or other regulatory agency in support of, or as part of, an 
application for a research or marketing permit for the study drug for the purposes that 
were the subject of the investigation 
Endo will notify Investigators once one of the above 2 timeframes has been satisfied. 

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If the investigation does not result in the submission of the data in support of, or as part of, an 
application for a research or marketing permit, records must be retained for a period of 2 years 
following notification by Endo Pharmaceuticals Inc. that the entire clinical investigation (not 
merely the Investigator’s portion) is completed, terminated, or discontinued or 2 years following 
withdrawal of the Investigational New Drug application (IND).  
If the Investigator retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the study records, custody must be transferred to a person who will accept the 
responsibility. Endo must be notified in writing of the name and address of the new custodian. 
Study records should not be destroyed without consultation with Endo Pharmaceuticals Inc. 
24.6. 
Subject Confidentiality 
All subject records submitted to Endo Pharmaceuticals Inc. or its designee will be identified only 
by initials and subject identification number. Subjects’ names are not to be transmitted to Endo 
Pharmaceuticals Inc. The Investigator will keep a Master Subject List on which the identification 
number and the full name, address, and telephone number of each subject are listed. It is the 
Investigators’ responsibility to inform study subjects that representatives of the Sponsor, FDA, or 
other regulatory agencies may review all records that support their participation in the study. The 
Investigator will adhere to all privacy laws to which he/she is subject. 
 

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25. 
TERMINATION OF STUDY 
The Sponsor has the right to suspend or terminate the study at any time. The study may be 
suspended or terminated for any reason. 

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26. 
INVESTIGATOR’S AGREEMENT 
I agree to conduct the study in accordance with the protocol, and with all applicable government 
regulations and Good Clinical Practice guidance. 
 
 
 
 
_____/_____/______ 
Investigator’s Signature 
Date 
 
 
 
Typed Name of Investigator 
 

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27. 
REFERENCES 
1. Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part I. Pathophysiology. 
J Am Acad Dermatol 2010;62(3):361-370. 
2. Hexsel D, de Oliveira Dal’Forno T, Mazzuco R. Definition, clinical aspects, 
classifications, and diagnostic techniques. In: Goldman MP, Hexsel D, eds. Cellulite: 
Pathophysiology and Treatment. 2nd ed. New York, NY: Informa Healthcare; 
2010:13-21. 
3. Rawlings AV. Cellulite and its treatment. Int J Cosmetic Sci. 2006;28(3):175-190. 
4. Terranova F, Berardesca E, Maibach H. Cellulite: nature and aetiopathogenesis. Int J 
Cosmetic Sci. 2006;28(3):157-167. 
5. Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther. 
2004;6(4):181-185. 
6. Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part II. Advances and 
controversies. J Am Acad Dermatol 2010;62(3):373-384. 
7. Collis N, Elliot LA, Sharpe C, Sharpe DT. Cellulite treatment: a myth or reality: a 
prospective randomized, controlled trial of two therapies, endermologie and 
aminophylline cream. Plast Reconstr Surg. 1999;104(4):1110-1114. 
8. Hexsel DM, Mazzuco R. Subcision: a treatment for cellulite. Int J Dermatol. 
2000;39(7):539-544. 
9. Boyce S, Pabby A, Chuchaltkaren P, Brazzini B, Goldman MP. Clinical evaluation of a 
device for the treatment of cellulite: Triactive. Am J Cosmet Surg. 2005;22:233-237. 
10. DiBernardo BE. Treatment of celllulite using a 1440-nm pulsed laser with one-year 
follow-up. Aesthet Surg J. 2011;31(3):328-341. 
11. Dagum AB, Badalamente MA. Collagenase injection in the treatment of cellulite. Plas 
Reconst Surg. 2006;118(suppl 4):53. 
12. Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity scale. 
J Eur Acad Dermatol Venereol. 2009;23(5):523-528. 
13. Nürnberger F, Müller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 
1978;4(3):221-229. 
 

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LIST OF APPENDICES 
Appendix A  Documents Required Prior to Initiation of the Study 
Appendix B  Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity 
scale. J Eur Acad Dermatol Venereol. 2009;23(5):523-528. 
Appendix C  Reference Images for Hexsel Severity Ratings 
Appendix D 
Patient Instructions for Use of the PR-PCSS 

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APPENDIX A. DOCUMENTS REQUIRED PRIOR TO INITIATION OF 
THE STUDY 
As a Sponsor of a clinical study, Endo Pharmaceuticals Inc. has an obligation to ensure that the 
study will be conducted by a qualified Investigator with sufficient resources of time, personnel, 
and physical facilities to conduct the study and to ensure that the Investigator understands and 
agrees to comply with the protocol, applicable regulations, policies, and procedures. The 
following documentation is required: 
From the Principal Investigator 
1. A signed agreement to perform the study per protocol (the signature page will suffice). 
2. A signed Letter of Financial Agreement (including confidentiality statement). 
3. Name(s) of the Principal Investigator and of all sub-Investigator(s) 
4. All address(es) of the clinical site(s). 
5. A current medical license valid where he/she practices and a current curriculum vitae for 
the Principal Investigator (signed and dated) and all sub-investigators, to contain at least 
the following elements: 
a. For physicians: 
i. Date of degree in Medicine 
ii. Name of the Institution granting the degree in Medicine. 
iii. Previous clinical postings with dates. 
b. For non-physician allowed by national law or regulations to act as clinical 
Investigators: 
i. Date and description of most advanced degree. 
ii. Name of the Institution granting the degree in number (i). 
iii. Other accreditation or qualifications relevant to the study. 
iv. Previous postings with dates. 
v. Name and qualification (see 5a above) of the physician or dentist in charge of 
study subjects. 
Note: If a non-physician is serving as Principal Investigator, then a qualified physician 
must be assigned as a sub-Investigator for the trial, to be responsible for all trial-related 
medical decisions. 
6. Written notification of Institutional Review Board/Independent Ethics Committee/Human 
Research Ethics Committee (IRB/IEC/HREC) approval. The minimum requirements are 
as follows: 
a. Dated letter, including: 
i. The date on which the meeting for the review of the study protocol took place. 
ii. Study protocol/amendment number, and version date 

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iii. A clear statement of approval of the protocol and the informed consent text with 
version date, and authorization for the study to proceed. 
iv. If the Investigator or any sub-Investigator is a part of the IRB/IEC/HREC 
Review Board, assurance that the Investigator abstained from voting at the 
meeting(s) when the study was discussed.  
b. A dated list of the members and their occupations. 
c. A specimen copy of the Committee-approved informed consent text to be used in the 
study. 
7. Food and Drug Administration (FDA) Form 1572 (for studies submitted under a US 
Investigational New Drug application [IND]). 
8. Financial Disclosure Certification or Certification of Non-Disclosure (for studies to be 
submitted for a US New Drug Application/Biologics License Application [NDA/BLA]). 
Other 
Any other documentation required by national law or regulations to be in the possession of the 
Sponsor or the Investigator for study participation or study initiation. 
 

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APPENDIX B. HEXSEL DM, DAL’FORNO T, HEXSEL CL. A 
VALIDATED PHOTONUMERIC CELLULITE SEVERITY 
SCALE. J EUR ACAD DERMATOL VENEREOL. 
2009;23(5):523-528. 
 

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APPENDIX D. PATIENT INSTRUCTIONS FOR USE OF PATIENT-
REPORTED PHOTONUMERIC CELLULITE SEVERITY 
SCALE (PR-PCSS) 
 

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EN3835-202 Protocol Amendment 1 
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2. 
SUMMARY OF CHANGES 
The EN3835-202 protocol amendment and amended informed consent form (as necessary) have 
been reviewed and approved by the governing IRBs before implementation of the amendment at 
each study center. 
Amendment 1 was incorporated into the protocol on July 5, 2016. The major reason for this 
amendment is to clarify that the investigators will conduct the assessment. 
 
Section 
Original Text 
Revised Text 
13.1.1.5 
Investigator 
Global 
Aesthetic 
Improvement 
Scale (I-GAIS) 
Subjects in the observation-only group will 
complete the I-GAIS as described below at 
the final study visit (month 12 or early 
termination) and a comparison back to the 
pre-treatment day 1 (Baseline) image of the 
assigned quadrant of the double-blind 
study. 
Investigators will complete the I-GAIS 
on subjects in the observation-only group 
as described below at the final study visit 
(month 12 or early termination) and a 
comparison back to the pre-treatment 
day 1 (Baseline) image of the assigned 
quadrant of the double-blind study. 
 
 

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4. 
SYNOPSIS 
Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Title of Study: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous 
Fibrosclerotic Panniculopathy 
Lead Principal Investigator: To be determined 
Study period:  
Estimated date first subject enrolled: Jun-2016 
Estimated date last subject completed: May-2017 
Phase of development: Phase 2 
Objectives:  
Primary: 
x 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at 
scheduled intervals over 1 year (12 months) in all subjects with edematous fibrosclerotic 
panniculopathy (EFP) who elect to enroll in this open-label trial regardless of their decision to 
receive treatment (re-treatment or re-dosing) of open-label EN3835 or opt to receive no 
treatment.  
Secondary: 
x 
To evaluate the durability of response to EN3835 in EFP severity over the 12-month post initial 
dosing of EN3835 in subjects previously receiving active treatment in study EN3835-201 using 
the Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), the Clinician-Reported 
Photonumeric Cellulite Severity Scale (CR-PCSS), and the Hexsel Cellulite Severity Scale 
(CSS) 
x 
To evaluate long-term response to EN3835 in assessments of EFP including subject satisfaction, 
Investigator Global Aesthetic Improvement Scale (I-GAIS), and Subject Global Aesthetic 
Improvement Scale (S-GAIS) 
x 
To evaluate immunogenicity after exposure to EN3835 
Study Design: This study is a Phase 2 open-label study for the safety and efficacy of EN3835 in the 
treatment of EFP. To be eligible, a subject must have participated and completed the previous cellulite 
study EN3835-201. Subjects will be screened for study eligibility within 14 days prior to enrolling in 
this study (EN3835-202). Subjects will be assessed for safety and cellulite severity assessments 
approximately every 3 months for a maximum of 1 year from their first exposure to EN3835. Subjects 
with at least 1 quadrant with moderate or severe level of cellulite will be eligible for treatment with 
EN3835 after unblinding of study EN3835-201; a quadrant that was treated with EN3835 in the previous 
study EN3835-201 will only be eligible for retreatment if the cellulite severity in that quadrant is rated at 
levels of cellulite severity at baseline in study EN3835-201. 
A treatment course will consist of 3 treatment sessions separated by 21 days. Treatment will be allowed 
in eligible subjects up to a maximum of 2 treatment courses including the treatment course in study 
EN3835-201 if subject was treated with EN3835. Each treatment session will consist of up to 
12 injections (0.07 mg/0.3 mL per injection) of EN3835 for a dose of 0.84 mg and volume of 3.6 mL. 
Only a quadrant with moderate (rating of 3) or severe (rating 4) level of severity as assessed by the 
subject and investigator using the PR-PCSS and the CR-PCSS, respectively, will be eligible for 

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treatment; if more than 1 eligible quadrant exists, the quadrant selected will be at the discretion of the 
subject. Treatments will be administered on days 1, 22, and 43; subjects will be assessed for safety on 
days 1, 22, 43, and 71 and for cellulite severity assessments on days 1, 43, and 71. After day 71, they 
will be observed every 3 months from their first exposure to EN3835 up to a maximum of 1 year. The 
study will terminate when at least 100 subjects have been assessed at 12 months after the first exposure 
to EN3835. 
Number of subjects (planned): 333 
Study center(s): 16 sites in the United States  
Diagnosis and inclusion/exclusion criteria: 
Qualification for the Open-Label Observation Phase of the Study 
Inclusion criteria for observation:  
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be willing to apply sunscreen to any treated quadrant before each exposure to the sun while 
participating in the study (ie, screening through end of study) 
Exclusion criteria for observation: 
None 
Qualification for the Open-Label Treatment Phase of the Study 
Inclusion criteria for treatment: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 and all day 71 
assessments 
3. %HDIHPDOH\HDUVRIDJH 
4. At Screening B visit, have at least 1 quadrant with: 
a. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 
b. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and 
c. a Hexsel CSS score no greater than 13 
5. Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun 
while participating in the study (ie, Screening B through end of study) 
6. Be judged to be in good health, based upon the results of a medical history, physical 
examination, and laboratory profile at Screening B 
7. Have a negative urine pregnancy test at Screening B and before injection of study drug and be 
using an effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal 
[estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle 
prior to study enrollment and for the duration of the study; or be menopausal defined as 
12 months of amenorrhea in the absence of other biological or physiological causes, as 
determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile 
8. Be willing and able to cooperate with the requirements of the study 
9. Be able to read, complete and understand the patient-reported outcomes rating instruments in 
English 

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Exclusion criteria for treatment: 
1. Has used any of the following for the treatment of EFP on the legs or buttock within the 
timelines identified below or intends to use any of the following at any time during the course of 
the study: 
x 
Liposuction on the side of the body selected for treatment during the 12-month period 
before injection of study drug 
x 
Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery 
(including subcision and/or powered subcision) within the selected treatment quadrant 
during the 12-month period before injection of study drug 
x 
Endermologie or similar treatments within the selected treatment quadrant during the 
6-month period before injection of study drug 
x 
Massage therapy within the selected treatment quadrant during the 3-month period before 
injection of study drug 
x 
Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected 
treatment quadrant during the 2-week period before injection of study drug 
2. Is presently nursing a baby or providing breast milk for a baby 
3. Intends to become pregnant during the study 
4. Has received an investigational drug or treatment within 30 days before injection of study drug 
5. Has a known systemic allergy to collagenase or any other excipient of study drug 
6. Is currently receiving or plans to receive anticoagulant or antiplatelet medication or has received 
DQWLFRDJXODQWRUDQWLSODWHOHWPHGLFDWLRQH[FHSWIRUPJDVSLULQGDLO\ZLWKLQGD\VEHIRUH
injection of study drug 
7. Has a known recent history of stroke, bleeding, or other medical condition, which in the 
investigator’s opinion would make the subject unsuitable for enrollment in this phase of the 
study 
8. Presence of any clinically relevant conditions, that in the opinion of the Investigator would 
interfere with completing the study including, but not limited to, visual problems, hearing 
problems, cognitive impairment or acute mental illness 
Investigational product, dosage and mode of administration: EN3835, 0.84 mg, subcutaneous. A 
dose of 0.84 mg of EN3835 will be administered as up to 12 subcutaneous injections (0.3-mL injection 
administered as three 0.1-mL aliquots per injection, up to 12 injections per treatment session) for a 
maximum volume of 3.6 mL per treatment session. A treatment course will consist of 3 treatment 
sessions at 21 days intervals, ie, treatments on days 1, 22, and 43 of each treatment course. 
For the observational periods of this study, subjects will be assessed for safety and cellulite severity 
assessments at approximately 3-month intervals for a maximum of 1 year following their first exposure 
to EN3835. 
Duration of study: Twelve (12) months from first exposure to EN3835 in study EN3835-201 or study 
EN3835-202 
Screening Phase: Up to 14 days 
Observational Phase: Subjects will be assessed at visits that occur approximately every 3 months for a 
maximum of 1 year after the first exposure to EN3835. 
Follow-up: Subjects will be assessed at visits that occur approximately every 3 months for a maximum 
of 1 year after the first exposure to EN3835. For subjects treated with EN3835 in this study, subjects 
will be observed at treatment visits (days 1, 22, and 43) and day 71 after first injection. 

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Reference therapy, dosage and mode of administration: Not applicable 
Criteria for evaluation: 
Efficacy: 
x 
PR-PCSS while viewing digital images of the selected quadrant: 5-point scale ranging from 
0 (no cellulite) to 4 (severe cellulite) (approximately every 3 months after initial injection [either 
an injection in previous study EN3835-201 or after an injection in this study]). If treatment is 
administered in this study, PR-PCSS will be obtained at Screening B (Baseline), days 22, 43, 
and 71 after initial treatment within this study. 
x 
Investigator using the CR-PCSS by live assessment: 5-point scale ranging from 0 (no cellulite) 
to 4 (severe cellulite) (every 3 months after initial injection [either an injection in previous study 
EN3835-201 or after an injection in this study]). If treatment is administered in this study, 
CR-PCSS will be obtained at Screening B (Baseline), days 22, 43, and 71 after initial treatment 
within this study. 
x 
Investigator rating of cellulite severity using the total score from the Hexsel CSS: scores can 
range from 0 (no cellulite) to 15 (extremely severe cellulite) (day 360). If treatment is 
administered in this study, Hexsel CSS will be obtained in this study at Screening B (Baseline) 
and day 71 after initial treatment within this study. 
x 
I-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) (day 71) 
x 
S-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) (day 71) 
x 
Subject satisfaction with cellulite treatment assessment: 5-point scale ranging from 2 (very 
satisfied) to í2 (very dissatisfied) (day 71) 
Safety:  
Safety will be assessed throughout the study through the recording of: 
x 
Adverse events (AEs) 
x 
Vital signs 
x 
Clinical laboratory tests 
x 
Immunogenicity assessment (ie, assessed through the determination of binding and neutralizing 
anti-AUX-I and anti-AUX-II antibody levels). 
In addition, for subjects treated with EN3835 in this study, injection site reactions/local tolerability in 
treated quadrant (through subject and Investigator reporting) will be assessed. 
Statistical methods: 
Sample Size Consideration:  
The number of subjects (approximately 333) is intended to obtain additional subjects for adequate long-
term safety data at the selected dose. 
Analysis Populations:  
Observational population: The Observational population is defined as all subjects treated with EN3835 
in study EN3835-201 who do not receive any treatment in the current study 
Safety population: The Safety population is defined as all enrolled subjects who received at least 1 
injection of EN3835 in this study or in study EN38335-201. 
Intent-to-Treat (ITT) population: The ITT population is defined as all enrolled subjects in this study. 

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Modified Intent-to-Treat (mITT) population: The mITT population is defined as ITT subjects who 
received at least 1 injection of EN3835 in this study with a baseline and 1 post-injection evaluation of 
both the CR-PCSS and PR-PCSS. All efficacy (cellulite assessments) analyses will be completed on this 
population. 
Per-Protocol population: The Per-Protocol population is defined as those subjects in the Safety 
population who have no major protocol deviations.  
Efficacy Evaluations: 
The primary cellulite severity assessment endpoint, the proportion of composite responders with 
improvement of 2 or better on each scale (CR-PCSS and PR-PCSS) at day 71, will be summarized as 
percentages and analyzed using a Cochran-Mantel-Haenszel test that compares the 2 treatment groups 
and adjusts for Investigator. The ITT population will be evaluated for the primary endpoint with any 
subjects not having a post-injection evaluation of either CR-PCSS or PR-PCSS classified as a 
non-responder. 
All secondary endpoints, except the Hexsel CSS total score, will be summarized as percentages. The 
dichotomous secondary endpoints (ie, responders endpoints) will be analyzed using a Cochran-Mantel-
Haenszel test adjusted for investigator. Multiple-response endpoints (ie, scales) will be analyzed using 
the Mann-Whitney test. Change in Hexsel CSS total score will be summarized with descriptive statistics 
for continuous variable and will be analyzed using analysis of variance (ANOVA). 
Safety Analysis:  
The following variables are safety endpoints: 
x 
AEs: Mapped to preferred term using the Medical Dictionary for Regulatory Activities 
(MedDRA) 
x 
Vital signs 
x 
Clinical laboratory tests 
AEs will be summarized by proportion of subjects reporting each event. Descriptive statistics will be 
presented for actual and change from baseline at each visit for vital signs and for each clinical laboratory 
test parameter. 
Immunogenicity: Anti-AUX-I and anti-AUX-II antibody levels will be summarized using descriptive 
statistics for the actual value at the visit. 
 

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5. 
SCHEDULE OF EVENTS 
NOTE: Observation visits (Table 2) in the open-label extension study begin after completion of 
double-blind study (day 71). Treatment sessions (Table 3), if elected, will begin when study drug 
blind is broken in study EN3835-201while observation visits continue concurrently. 
 

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a Eligible subjects may choose additional treatment any time after the study drug blind is broken in study EN3835-201. 
b Upon completion of treatment, subject will be followed at 3-month intervals as in Table 2; if study terminates early, subject will be followed through Visit 4 
(day 71). If subject received placebo in the double-blind study (EN3835-201), she may be eligible for a total of 2 courses of treatment (a total of 6 treatment 
sessions) in this study. 
c All 4 quadrants are photographed at screening; at other visits, the selected quadrant only is photographed. 
d Before and after marking the dimples. 
e Before injection. 
f Up to 4 hours before injection; approximately 15 and 30 minutes after injection. Vital signs must be stable before the subject is discharged. 
g Assessment made via photograph (if treatment session, use photograph taken before marking dimples). 
h All 4 quadrants are assessed at the Screening B visit; at other visits, the selected quadrant only is assessed. 
i Initial Hexsel CSS at sFUHHQLQJPXVWEHRQselected quadrant (Appendix C). 
j To qualify for treatment, the selected quadrant must have a score of 3 or 4 (moderate or severe) in both the CR-PCSS and PR-PCSS, and a Hexsel CSS score 
; to qualify a quadrant that had been previously treated with EN3835 in study EN3835-201, the quadrant must have CR-PCSS and PR-PCSS scores equal to 
or greater than study EN38325-EDVHOLQHVFRUHVDQGD+H[VHO&66VFRUH13. 
k Medical history and prior medications will be based on EN3835-201 eCRF; only updates and concomitant medications need to be captured at Screening B visit. 
l Do not conduct if Screening B visit date is within 12 months of obtaining an ECG during the double-blind study (EN3835-201). 
ECG=Electrocardiogram; eCRF=Electronic case report form; EFP=Edematous fibrosclerotic panniculopathy; Tx=Treatment 
NOTE: Subject cellulite assessments must be completed before the Investigator cellulite assessments are conducted at each visit. 
 

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6. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES 
TABLE OF CONTENTS 
1. 
TITLE PAGE ................................................................................................................1 
2. 
SUMMARY OF CHANGES ........................................................................................2 
3. 
SPONSOR CONTACT INFORMATION ...................................................................3 
4. 
SYNOPSIS ...................................................................................................................4 
5. 
SCHEDULE OF EVENTS ...........................................................................................9 
6. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ...............13 
7. 
LIST OF ABBREVIATIONS.....................................................................................19 
8. 
INTRODUCTION ......................................................................................................21 
8.1. 
Edematous Fibrosclerotic Panniculopathy .................................................................21 
8.2. 
Current Edematous Fibrosclerotic Panniculopathy Treatments .................................21 
8.3. 
EN3835 (Collagenase Clostridium Histolyticum) ......................................................23 
8.3.1. 
Studies with EN3835 for the Treatment of Edematous Fibrosclerotic 
Panniculopathy ...........................................................................................................23 
8.3.1.1. 
Investigator-Initiated Proof-of-Concept Study ...........................................................23 
8.3.1.2. 
Endo-Sponsored Phase 1b Dose-Escalation Study AUX-CC-830 .............................24 
8.3.1.3. 
Endo-Sponsored Phase 2a Dose-Ranging Study AUX-CC-831 ................................24 
8.3.1.4. 
Endo-Sponsored Phase 2b Study EN3835-201 ..........................................................24 
8.4. 
Summary of Nonclinical Studies ................................................................................25 
8.5. 
Summary of Known Risks and Benefits .....................................................................25 
8.6. 
Rationale .....................................................................................................................25 
9. 
OBJECTIVES .............................................................................................................26 
9.1. 
Primary Objective .......................................................................................................26 
9.2. 
Secondary Objectives .................................................................................................26 
9.3. 
Exploratory Objectives ...............................................................................................26 
10. 
INVESTIGATIONAL PLAN .....................................................................................27 
10.1. 
Study Design ...............................................................................................................27 
10.2. 
Selection of Doses ......................................................................................................29 
10.3. 
Study Drug Administration.........................................................................................29 
10.4. 
Discussion of Study Design, Including the Choice of Control Groups ......................29 

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11. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................30 
11.1. 
Observation Phase ......................................................................................................30 
11.1.1. 
Subject Inclusion Criteria for Observation .................................................................30 
11.1.2. 
Subject Exclusion Criteria for Observation ................................................................30 
11.2. 
Treatment ....................................................................................................................30 
11.2.1. 
Subject Inclusion Criteria for Treatment ....................................................................30 
11.2.2. 
Subject Exclusion Criteria for Treatment ...................................................................31 
11.3. 
Subject Discontinuation Criteria .................................................................................32 
11.3.1. 
Replacement Procedures .............................................................................................32 
12. 
PROCEDURES AND TREATMENTS .....................................................................33 
12.1. 
Study Visits .................................................................................................................33 
12.1.1. 
Subject Screening .......................................................................................................33 
12.1.2. 
Screening Assessments ...............................................................................................33 
12.1.3. 
Study Entry/Observational Assessments ....................................................................33 
12.1.3.1. 
Three-Month Assessments..........................................................................................33 
12.1.4. 
Treatment Assessments (Optional) .............................................................................34 
12.1.4.1. 
6FUHHQLQJ%'D\VíWRí5HODWLYHWR2SHQ-Label Treatment Visit Day 1) .........35 
12.1.4.2. 
Treatment Session 1 (Visit 1B)...................................................................................36 
12.1.4.3. 
Treatment Session 2 (Visit 2/Day 22 ± 3 Days) and Treatment Session 3 
(Visit 3/Day 43 ± 3 Days) ...........................................................................................39 
12.1.4.4. 
Day 71 (±5 Days) End of Treatment/Early Termination ............................................40 
12.1.4.5. 
Follow-up Visits .........................................................................................................41 
12.2. 
Prior and Concomitant Medications and Procedures ..................................................41 
12.2.1. 
Prohibited Medications ...............................................................................................41 
12.2.2. 
Prohibited Procedures .................................................................................................41 
12.3. 
Treatment Compliance ................................................................................................41 
12.4. 
Blinding and Randomization ......................................................................................41 
12.5. 
End of Study ...............................................................................................................42 
13. 
ASSESSMENT OF EFFICACY ................................................................................43 
13.1. 
Primary Efficacy Measurements .................................................................................43 
13.1.1. 
Subject and Investigator Cellulite Assessments .........................................................43 
13.1.1.1. 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) ........................43 
13.1.1.2. 
Subject Global Aesthetic Improvement Scale (S-GAIS)............................................47 

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13.1.1.3. 
Subject Satisfaction with Cellulite Treatment Assessment ........................................47 
13.1.1.4. 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) ....................48 
13.1.1.5. 
Investigator Global Aesthetic Improvement Scale (I-GAIS) .....................................51 
13.1.1.6. 
Hexsel Cellulite Severity Scale ..................................................................................51 
14. 
ASSESSMENT OF SAFETY .....................................................................................53 
14.1. 
Definitions ..................................................................................................................53 
14.1.1. 
Adverse Event .............................................................................................................53 
14.1.2. 
Serious Adverse Event ................................................................................................53 
14.2. 
Monitoring Adverse Events ........................................................................................54 
14.3. 
Relationship to Study Drug ........................................................................................54 
14.4. 
Intensity Assessment ..................................................................................................55 
14.5. 
Reporting Adverse Events and Serious Adverse Events ............................................55 
14.5.1. 
Reporting Adverse Events ..........................................................................................55 
14.5.2. 
Reporting Serious Adverse Events .............................................................................55 
14.5.2.1. 
Follow-up Procedures for Serious Adverse Events ....................................................56 
14.6. 
Special Reporting Situations .......................................................................................56 
14.6.1. 
Adverse Events of Special Interest .............................................................................56 
14.6.2. 
Overdose/Misuse/Abuse .............................................................................................56 
14.6.3. 
Pregnancy ...................................................................................................................57 
14.6.4. 
Adverse Events/Serious Adverse Events Experienced by Non-subjects 
Exposed to Study Medication .....................................................................................57 
14.7. 
Clinical Laboratory and Immunogenicity Determinations .........................................57 
14.7.1. 
Anti-AUX-I and Anti-AUX-II Antibodies .................................................................58 
14.8. 
Vital Signs ..................................................................................................................59 
14.9. 
Electrocardiogram .......................................................................................................59 
14.10. 
Physical Examination .................................................................................................59 
14.11. 
Other Safety Assessments ...........................................................................................60 
15. 
ASSESSMENT OF PHARMACOKINETICS ...........................................................61 
16. 
ASSESSMENT OF PHARMACODYNAMICS ........................................................62 
17. 
STATISTICAL CONSIDERATIONS AND METHODS .........................................63 
17.1. 
Determination of Sample Size ....................................................................................63 
17.2. 
Subject Cohorts and Subject Populations ...................................................................63 
17.2.1. 
Observational Population ............................................................................................63 

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17.2.2. 
Safety Population ........................................................................................................63 
17.2.3. 
Intent-to-Treat Population ..........................................................................................64 
17.2.4. 
Modified Intent-to-Treat Population ...........................................................................64 
17.2.5. 
Per-Protocol Population ..............................................................................................64 
17.3. 
Subject Disposition .....................................................................................................64 
17.4. 
Demographics and Other Baseline Characteristics .....................................................64 
17.5. 
Efficacy Analyses .......................................................................................................64 
17.5.1. 
Primary Efficacy Analysis ..........................................................................................65 
17.5.2. 
Secondary Efficacy Analysis ......................................................................................65 
17.6. 
Safety Analyses ..........................................................................................................68 
17.6.1. 
Prior, Concomitant, and Follow-up Medication .........................................................68 
17.6.2. 
Study Drug Exposure ..................................................................................................69 
17.6.3. 
Measurement of Treatment Compliance ....................................................................69 
17.6.4. 
Adverse Events ...........................................................................................................69 
17.6.5. 
Vital Signs ..................................................................................................................69 
17.6.6. 
Clinical Laboratory Parameters ..................................................................................70 
17.7. 
Immunogenicity Analyses ..........................................................................................70 
17.8. 
Pharmacokinetic Analyses ..........................................................................................70 
17.9. 
Interim Analysis ..........................................................................................................70 
17.10. 
Statistical Software .....................................................................................................70 
18. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................71 
18.1. 
Study Drug Identity ....................................................................................................71 
18.2. 
Study Drug Packaging and Labeling ..........................................................................71 
18.3. 
Study Drug Storage .....................................................................................................71 
18.4. 
Study Drug Preparation ..............................................................................................71 
18.5. 
Study Drug Accountability .........................................................................................71 
18.5.1. 
Study Drug Handling and Disposal ............................................................................72 
19. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................73 
19.1. 
Source Documents ......................................................................................................73 
19.2. 
Study Monitoring ........................................................................................................73 
19.3. 
Audits and Inspections ................................................................................................73 
19.4. 
Institutional Review Board (IRB) ...............................................................................73 
19.5. 
Data Recording and Documentation ...........................................................................73 

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20. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................74 
21. 
ETHICS ......................................................................................................................75 
21.1. 
Ethics Review .............................................................................................................75 
21.2. 
Ethical Conduct of the Study ......................................................................................75 
21.3. 
Subject Information and Consent ...............................................................................76 
22. 
DATA HANDLING AND RECORDINGKEEPING ................................................77 
22.1. 
Data Collection ...........................................................................................................77 
22.2. 
Study Documentation .................................................................................................77 
23. 
REPORTING AND PUBLICATION .........................................................................78 
24. 
INVESTIGATOR OBLIGATIONS ...........................................................................79 
24.1. 
Regulatory Documents ...............................................................................................79 
24.2. 
Delegation of Responsibilities and Adequate Resources ...........................................80 
24.3. 
Medical Care of Study Subjects .................................................................................80 
24.4. 
Use of Investigational Materials .................................................................................80 
24.5. 
Retention of Records ..................................................................................................80 
24.6. 
Subject Confidentiality ...............................................................................................81 
25. 
TERMINATION OF STUDY ....................................................................................82 
26. 
INVESTIGATOR’S AGREEMENT ..........................................................................83 
27. 
REFERENCES ...........................................................................................................84 
APPENDIX A. DOCUMENTS REQUIRED PRIOR TO INITIATION OF THE 
STUDY .......................................................................................................................86 
APPENDIX B. HEXSEL DM, DAL’FORNO T, HEXSEL CL. A VALIDATED 
PHOTONUMERIC CELLULITE SEVERITY SCALE. J EUR ACAD 
DERMATOL VENEREOL. 2009;23(5):523-528. .......................................................88 
APPENDIX C. REFERENCE IMAGES FOR HEXSEL SEVERITY RATINGS ....................96 
APPENDIX D. PATIENT INSTRUCTIONS FOR USE OF PATIENT-REPORTED 
PHOTONUMERIC CELLULITE SEVERITY SCALE (PR-PCSS) .........................97 
 

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LIST OF TABLES 
Table 1: 
Sponsor Contact Information ........................................................................................3 
Table 2: 
Observation Assessments ...........................................................................................10 
Table 3: 
Treatment Session Assessments .................................................................................11 
Table 4: 
Abbreviations and Specialist Terms ...........................................................................19 
Table 5: 
Concomitant Medication Restrictions for Subjects During the Treatment 
Phase of Study ............................................................................................................41 
Table 6: 
Subject Global Aesthetic Improvement Scale (S-GAIS)............................................47 
Table 7: 
Subject Satisfaction with Cellulite Treatment Assessment ........................................48 
Table 8: 
Investigator Global Aesthetic Improvement Scale (I-GAIS) .....................................51 
Table 9: 
Hexsel Cellulite Severity Scale ..................................................................................52 
Table 10: Clinical Laboratory Parameters ..................................................................................58 
Table 11: Vital Signs Measurements on Injection Day ..............................................................59 
 
LIST OF FIGURES 
Figure 1: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the 
Buttock ........................................................................................................................45 
Figure 2: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the 
Thigh ...........................................................................................................................46 
Figure 3: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for 
the Buttock ..................................................................................................................49 
Figure 4: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for 
the Thigh .....................................................................................................................50 
 
 

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7. 
LIST OF ABBREVIATIONS  
The following abbreviations and specialist terms are used in this study protocol. 
Table 4: 
Abbreviations and Specialist Terms 
Abbreviation 
Definition 
AE 
Adverse event 
Assigned quadrant 
Assigned quadrant (ie, left or right buttock, or the left or right posterolateral 
thigh) that was suitable for treatment and was randomly assigned in the double-
blind study (EN3835-201). To be suitable for treatment the quadrant must have 
an Investigator CR-PCSS and subject PR-PCSS score of 3 or 4 and a Hexsel 
CSS score of no greater than 13 at Screening B visit and at Day 1 visit. 
AUX-I 
Clostridial class I collagenase 
AUX-II 
Clostridial class II collagenase 
CFR 
Code of Federal Regulations 
CRF 
Case report form 
CR-PCSS 
Clinician-Reported Photonumeric Cellulite Severity Scale 
CSS 
Cellulite Severity Scale 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EFP 
Edematous fibrosclerotic panniculopathy 
FDA 
Food and Drug Administration 
GCP 
Good clinical practice 
HREC 
Human research ethics committee 
IB 
Investigator Brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent ethics committee 
I-GAIS 
Investigator-Global Aesthetic Improvement Scale 
IND 
Investigational new drug 
IRB 
Institutional review board 
ITT 
Intent-to-treat 
kDa 
Kilodalton 
MedDRA 
Medical Dictionary for Regulatory Activities 

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Table 4: 
Abbreviations and Specialist Terms (Continued) 
Abbreviation 
Definition 
mITT 
Modified intent-to-treat 
PCS 
Potentially clinically significant 
PR-PCSS 
Patient-Reported Photonumeric Cellulite Severity Scale 
Qualified designee 
Qualified by education and training to perform the study procedure (eg, 
sub-Investigator, nurse) 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
Selected quadrant 
Quadrant (ie, left or right buttock, or the left or right posterolateral thigh) that is 
suitable for treatment and is selected by patient and investigator for treatment. 
To be suitable for treatment the quadrant must have an Investigator CR-PCSS 
and subject PR-PCSS score of at least 3 or 4 and a Hexsel CSS score of no 
greater than 13 at Screening B visit. 
S-GAIS 
Subject – Global Aesthetic Improvement Scale 
TEAE 
Treatment-emergent adverse event; adverse events that occur on or after the 
first injection of study drug 
 

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8. 
INTRODUCTION 
8.1. 
Edematous Fibrosclerotic Panniculopathy 
Edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite, has been defined 
as a local metabolic disorder of subcutaneous tissues that results in an alteration of skin 
topography.(1) The condition manifests as dimpled skin, described as an orange-peel, cottage 
cheese, or mattress texture, particularly in the gluteal-femoral region.(2,3) EFP is caused by 
herniation of subcutaneous fat lobules through the dermohypodermal junction. This creates an 
uneven surface with dimpling.(1) EFP is a medical condition resulting in a potentially 
cosmetically unacceptable alteration of the skin, and affects an estimated 85% to 98% of 
postpubertal women.(1,3) 
The pathophysiology of EFP is not completely understood, but there are 3 main theories: edema 
resulting from excessive hydrophilia of the intercellular matrix, alteration of the regional 
microcirculation, and different anatomical conformation of collagenous subcutaneous tissues in 
women versus men.(4) 
It is known that EFP is different from generalized obesity. In generalized obesity, adipocytes 
undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs, and abdomen.(1) 
In areas of EFP, adipocytes have physiologic and biochemical properties that differ from adipose 
tissue located elsewhere. Large, metabolically-stable adipocytes characterize EFP-prone areas; 
thus, the responsiveness to catecholamine-induced lipolysis is less in EFP tissues compared to 
visceral fat, which has the greatest responsiveness.(1) 
Subcutaneous fat lobes are separated from one another by thin, usually rigid strands of 
collagenous connective tissues, which cross the fatty layers and connect the dermis to the 
underlying fascia. These septa stabilize the subcutis and divide the fat. In EFP, shortening of the 
collagen septa due to fibrosis provokes retraction at the insertion points of the trabeculae, 
causing the depressions that characterize EFP.(2) There are a higher percentage of thinner, 
perpendicular hypodermal septa in women with EFP than in men.(1) Weight gain makes EFP 
more noticeable, but it may be present even in thin subjects. Genetics may also play a role since 
EFP tends to run in families. 
8.2. 
Current Edematous Fibrosclerotic Panniculopathy Treatments 
There are therapies that have been utilized in an attempt to treat cellulite. Despite multiple 
therapeutic modalities, there is little scientific evidence that any of these treatments are 
beneficial. In fact, much of the evidence is anecdotal, subjective, or based only on patient self-
assessment.(5) Some of the historical treatments for EFP have included: 
x Weight loss: Weight loss generally decreases the severity of EFP but may only have a 
variable effect on EFP grades.(6) 
x Pharmacological agents (eg, xanthines, retinoids, lactic acid, and herbals): Although 
there are numerous topical treatments that are available over the counter, there are no 
well-designed or large-scale studies demonstrating the effectiveness of any of these 

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therapies.(5) Additionally, ingredients in some of the topical treatments are unknown 
and may pose an increased risk for adverse effects.(5) 
x Massage: Endermologie or lipomassage kneads the skin between rollers. This type of 
vigorous massage is posited to increase blood flow and reduce excess fluid in EFP 
prone areas. In a 12-week, randomized, controlled study of 52 women that examined 
the effectiveness of either endermologie or aminophylline versus a combination of 
both, there was no statistical difference in the thigh measurement between 
subjects.(7) 
x Liposuction: Liposuction can reshape the body, but it does not typically correct 
cellulite as it does not interrupt collagen septae in a directed fashion. Additionally, 
liposuction is not a recommended treatment for cellulite given the potential for poor 
cosmetic outcome.(5,6) 
x Mesotherapy: Mesotherapy involves injecting solutions containing various 
substances, eg, methylxanthines, to dissolve subcutaneous fat; however, this type of 
therapy often results in unwanted side effects, including infection, urticarial reactions, 
and bumpy or uneven skin contours.(6) To date, there are no regulatory approved 
mesotherapy mixtures for the treatment of EFP. 
x Radiofrequency: Radiofrequency systems may temporarily improve the appearance of 
EFP after a series of treatments; but long-term efficacy has not been demonstrated.(6) 
x Subcision: Subcision is an invasive surgical technique that severs the septa holding 
fat lobules that cause the skin dimpling associated with EFP. In a study conducted by 
Hexsel and Mazzuco, 232 subjects had subcision for the treatment of EFP.(8) 
Although 78% of subjects were satisfied after 1 treatment, there were no objective 
criteria by which to assess improvement, thereby limiting the value of this study. 
Additionally, side effects reported in this study included pain, bruising for 3 to 6 
months, hyperpigmentation for 2 to 10 months, and skin puckering.(5,6) These effects 
are most likely due to the trauma from shearing the septa with a large gauge needle 
(eg, 16 or 18 gauge) or other cutting devices. 
x Powered subcision: Powered subcision is a surgical technique utilizing a powered 
needle apparatus to sever the septa holding fat lobules that cause skin dimpling 
associated with EFP. The Cellfina® powered subcision device was recently approved 
by Food and Drug Administration (FDA; 2015) for the treatment of cellulite. 
x Laser: Intense pulsed light has been investigated for the treatment of cellulite. 
Triactive® is an FDA-approved low-fluorescence 810-nm light source combined with 
a 915-nm laser. In a study of 16 female subjects who underwent 12 treatments with 
the Triactive, 21% had improvement (based on 5 blinded Investigators’ analysis of 
photographs with respect to appearance of cellulite, skin tone, and texture) of their 
cellulite.(9) The CelluLaze™ system was used to treat cellulite on the thighs of 
10 healthy women.(10) In this Investigator-initiated study, subjects received a single 
treatment with a 1440-nm laser. During the CelluLaze procedure, which is performed 
under a local tumescent and general anesthetic, the physician inserts a small cannula 
through the skin and the device technology directs controlled, laser thermal energy to 

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the treatment zones. The laser is designed to diminish the lumpy pockets of fat by 
melting the hypodermal fat; release the areas of skin depression through thermal 
subcision of the septal tissue; and increase the elasticity and thickness of the skin by 
melting the fat in the dermal invaginations. Subjective physician and subject 
evaluations indicated improvement in the appearance of cellulite and high patient 
satisfaction that persisted for a year. For both the Triactive and CelluLaze studies, 
there were no control groups and significance was not tested.  
There remains an unmet medical need for safe and effective nonsurgical therapies to improve the 
esthetic outcome in women with cellulite. To effectively treat cellulite, a therapeutic approach 
may require disruption of the dermal septa, which are composed of collagen and cause the skin 
dimpling which is bothersome to many women. 
8.3. 
EN3835 (Collagenase Clostridium Histolyticum) 
Endo Pharmaceuticals Inc. (Endo) is developing EN3835 for the treatment of EFP. Because 
EN3835 is a proteinase that can hydrolyze the triple-helical region of collagen under 
physiological conditions, EN3835 has the potential to be effective in lysing subdermal collagen, 
such as those observed in the dermal septa, which are the underlying cause of the skin dimpling 
in women with EFP. EN3835 targets the collagenase structural matrix (eg, dermal septa) at the 
site of injection and does not require systemic exposure to be effective. 
EN3835 is a parenteral lyophilized product comprised of 2 collagenases in an approximate 1:1 
mass ratio, Collagenase I (AUX-I, Clostridial class I collagenase) and Collagenase II (AUX-II; 
Clostridial class II collagenase). These collagenases are isolated and purified from the 
fermentation of Clostridium histolyticum. Collagenase AUX-I is a single polypeptide chain 
containing approximately 1,000 amino acids of known sequence and with a molecular weight of 
114 kDa. Collagenase AUX-II is also approximately 1,000 amino acids long and has a molecular 
weight of 113 kDa. These 2 collagenases are not immunologically cross-reactive and have 
different specificities, such that together they become synergistic, providing a very broad 
hydrolyzing reactivity toward collagen. Clostridial collagenases are proteinases that can 
hydrolyze the triple-helical region of collagen under physiological conditions. 
EN3835 is currently approved for: 1) the treatment of adults with Dupuytren’s contracture with a 
palpable cord and, 2) for the treatment of adult men with Peyronie’s disease with a palpable 
plaque and curvature deformity of at least 30 degrees at the start of therapy. 
8.3.1. 
Studies with EN3835 for the Treatment of Edematous Fibrosclerotic 
Panniculopathy 
The studies summarized in this section are described in more detail in the Investigator’s 
Brochure (IB). 
8.3.1.1. 
Investigator-Initiated Proof-of-Concept Study 
In an Investigator-initiated pilot study, 10 female subjects received EN3835 in the treatment of 
cellulite.(11) A 10×10-cm oval area was outlined on the posterolateral thigh and 0.58 mg 
EN3835 was injected using a template as 5 concurrent subcutaneous injections of 0.116 mg per 
injection. Subjects were followed up to 180 days after injection for reduction of the cellulite 
appearance in the injected area. At 1 month post injection, the area of cellulite (as measured from 

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photographs) was reduced 89% from baseline. Patient satisfaction score was 1.75 at month 6 
(1=completely satisfied, 4=not satisfied). Side effects included the local events of injection area 
soreness, ecchymosis, and mild edema; these resolved within a mean of 18 days. The results 
from this study suggest that the collagen septa of EFP may be an appropriate substrate for lysis 
with injectable collagenase, and that treatment with collagenase appears to be tolerable and 
possibly effective. However, due to the paucity of the data, no conclusions could be drawn 
regarding dose, frequency, and injection technique. 
8.3.1.2. 
Endo-Sponsored Phase 1b Dose-Escalation Study AUX-CC-830 
A dose-ranging Phase 1b dose escalation study (AUX-CC-830) used a template arrangement of 
injections as was used in the Investigator-initiated pilot study but injected a matrix of doses, 
concentrations and injectate volumes to select doses for further development. This Phase 1b 
study showed efficacy results suggesting that collagenase clostridium histolyticum (CCH) may 
be effective in the treatment of EFP based on global aesthetic improvement at day 90 with 
ratings of “improved” by 43.4% of Investigators and 52.5% of subjects. The majority of subjects 
(71.7%) were “quite satisfied” or “very satisfied” with treatment on day 90. Adverse 
events(AEs) were local injection site events (bruising, pain, erythema, and edema) were mild or 
moderate and resolved within a period of 3 weeks. 
8.3.1.3. 
Endo-Sponsored Phase 2a Dose-Ranging Study AUX-CC-831 
The Phase 2a study (AUX-CC-831) was a double-blind, placebo-controlled, dose-ranging study 
of 150 women randomized to 0.06, 0.48, or 0.84 mg of CCH; or placebo in a 5:5:5:3 ratio. Each 
subject could receive up to 3 treatment sessions of study drug separated by approximately 
21 days. Efficacy in this study was evaluated based on Investigator Global Aesthetic 
Improvement Scale (GAIS-I) and Subject Global Aesthetic Improvement Scale (GAIS-S) along 
with other measures of treatment efficacy. Improvements were observed in cellulite appearance 
based on the statistically significant changes in the appearance of cellulite based on both the 
GAIS-I and GAIS-S scores for the high and mid doses compared to placebo (p<0.05). The 
majority of the patients were either satisfied or very satisfied with the results of their cellulite 
treatment with the mid and high doses compared to placebo (p<0.05). Similar to the AEs 
reported in subjects in the previous study (AUX-CC-830) and subjects who received EN3835 for 
Dupuytren’s contracture and Peyronie’s disease, the majority of AEs occurred at the site of 
injection and resolved before the next scheduled treatment session. 
8.3.1.4. 
Endo-Sponsored Phase 2b Study EN3835-201 
Currently there is an ongoing Phase 2b study (EN3835-201) which is a double-blind, placebo-
controlled study of 350 adult women randomized to EN3835 0.84 mg or placebo in a 1:1 ratio. 
Each subject can receive up to 3 treatment sessions of study drug separated by approximately 
21 days; last visit is day 71. Efficacy is being evaluated using a Clinician-Reported 
Photonumeric Cellulite Severity Scale (CR-PCSS), a Patient-Reported Photonumeric Cellulite 
Severity Scale (PR-PCSS), the Hexsel Cellulite Severity Scale (CSS), GAIS-I, GAIS-S, and a 
subject satisfaction assessment. Subjects that complete study EN3835-201 will be offered the 
option of participating in study EN3835-202. 

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8.4. 
Summary of Nonclinical Studies 
Nonclinical studies necessary to support clinical studies have been performed and are 
summarized in the IB. Nonclinical studies in the following areas were performed: toxicology, 
reprotoxicity, genotoxicity, and carcinogenicity.  
8.5. 
Summary of Known Risks and Benefits 
A summary of safety risks is provided in the IB. The following events have been commonly 
observed in prior studies: injection site AEs such as bruising, edema, erythema and pain. 
There are previously generated potential clinical benefits associated with EN3835 in treating 
EFP, however, such potential benefits need further clinical evaluation. It is hoped that data from 
this clinical study will demonstrate a measurable sustained or durable clinical benefit of EN3835 
in EFP as well as longer term safety.  
8.6. 
Rationale 
This study will allow an evaluation of longer term safety (over 12 months) following EN3835 
treatment of subjects with EFP. Additionally, although uncontrolled, an assessment of cellulite 
assessments (efficacy) of EN3835 in the treatment of quadrants with moderate or severe cellulite 
will be conducted in subjects treated with placebo or EN3835 in the previous double-blind study 
(EN3835-201). The safety of re-dosing either in a previously treated quadrant (termed 
re-treatment) or in a naive quadrant (termed re-dosing) in subjects that previously received 
EN3835 treatment in study EN3835-201 will be assessed. Finally, the durability of improvement 
will be evaluated in enrolled subjects following EN3835 treatment in the double-blind study 
(EN3835-201) as well as those being treated with EN3835 in this open-label study 
(EN3835-202). 
 

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9. 
OBJECTIVES 
9.1. 
Primary Objective 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at scheduled 
intervals over 1 year (12 months) in all subjects with EFP who elect to enroll in this open-label 
trial regardless of their decision to receive treatment (re-treatment or re-dosing) of open-label 
EN3835 or opt to receive no treatment.  
9.2. 
Secondary Objectives 
x To assess safety and immunogenicity of re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
x To evaluate the durability of response to EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects previously receiving active-treatment in 
study EN3835-201 using the PR-PCSS, the CR-PCSS, and the Hexsel CSS 
x To evaluate long-term response to EN3835 in assessments of EFP including subject 
satisfaction, I-GAIS, and S-GAIS 
x To assess cellulite severity assessments in quadrants treated in this study with 
EN3835 
9.3. 
Exploratory Objectives 
There are no exploratory objectives for this open-label extension study. 
 

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10. 
INVESTIGATIONAL PLAN 
10.1. 
Study Design 
This open-label extension study will be performed at multiple centers currently participating in 
the double-blind, placebo-controlled, parent trial (EN3835-201) in the United States. The open-
label extension study will enroll up to 350 subjects. The study is planned to end when at least 
100 subjects have 12 months after exposure ie 12 months after first treatment in study 
EN3835-201 or study EN3835-202. Subjects who completed the entire double-blind study and 
sign an informed consent will be eligible to enter this open-label extension.  
After the Sponsor has broken the EN3835-201 study drug blind, subjects enrolled in the open-
label study will have the following options: 
x To have no EN3835 treatments in study EN3835-202 
x If received EN3835 in study EN3835-201, may elect to have a qualifying quadrant 
other than the one treated in study EN3835-201 treated with EN3835 (termed 
re-dosing) 
x If received EN3835 in study EN3835-201 and the cellulite severity scores of the 
treated quadrant have returned to or are greater than EN3835-201 baseline scores, 
may elect to have the previously treated quadrant retreated with EN3835 (termed 
re-treatment) 
x If received placebo in study EN3835-201, may elect to have a qualifying quadrant 
treated with EN3835; also may elect to have a second qualifying quadrant treated 
with EN3835 after completing the treatment course  
Subjects enrolled in study EN3835-202 who elect to receive EN3835 treatment (either 
re-treatment, re-dosing, or a first treatment) must meet specific inclusion and exclusion criteria 
for eligibility during re-screening (Screening B) prior to EN3835 dosing.  
Following completion of safety and cellulite assessments at day 71 of the double-blind study 
(EN3835-201), subjects will be asked if they wish to continue in the open-label extension to the 
double-blind study (Screening A). At the time of entry into the open-label study, subjects and 
Investigators will remain blinded to study drug. Until the EN3835-201 study drug blind is broken 
by the Sponsor, subjects will undergo observation-only visits at 3-month intervals ± 7 days 
(relative to the initial dose in the double-blind study) where both safety and cellulite severity 
assessments of the treated quadrant will be made. 
Following the study drug blind being broken and communicated to centers, treatments of eligible 
subjects with EN3835 can begin at a visit at the discretion of the subject. Subjects electing not to 
receive further EN3835 treatments (observation-only subjects) will continue to be followed for 
safety and cellulite severity assessments at 3-month intervals through month 12. Up to 14 days 
prior to initiating treatment injections of EN3835 on open-label treatment visit day 1, subjects 
will undergo a screening evaluation (Screening B) to determine if they meet specified inclusion 
and exclusion criteria and to determine the quadrants, if any, that qualify for treatment.  

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During Screening B, photographs will be taken of each of the subject’s 4 quadrants (left 
buttocks, right buttocks, left posterolateral thigh, and right posterolateral thigh). Subjects will 
again receive instructions for use of the PR-PCSS and will subsequently use the scale to rate the 
severity of their cellulite in each of the 4 quadrants by comparing digital images of each of their 
quadrants displayed on standardized computer monitors with the PR-PCSS instrument. This 
independent self-assessment will take place in a private setting to minimize any potential bias 
from site personnel. The Investigator will then assess the subject’s 4 quadrants live in real-time 
using the CR-PCSS. The Investigator will rate the 4 quadrants using the Hexsel CSS as described 
in section 13.1.1.6.(12) Subjects must have at least 1 quadrant that meets the following criteria 
for inclusion into the treatment phase of the study: 
1. PR-PCSS score of 3 or 4, and 
2. CR-PCSS score of 3 or 4, and  
3. Hexsel CSS score of no greater than 13. 
After the independent assessments are completed separately by the subject and the Investigator, 
the Investigator will review his/her assessments and the subject’s assessment to determine which 
quadrants, if any, are eligible. The eligible quadrant chosen to receive treatment in the open-label 
study EN3835-202 will be at the discretion of the subject. A quadrant may be chosen for 
re-treatment if it was the quadrant treated in study EN3835-201 or a new quadrant may be 
chosen for re-dosing. NOTE: For subjects who received active drug in the assigned 
quadrant in the double-blind study, the quadrant must have cellulite severity at (or 
greater) than the EN3835-201 baseline scores of PR-PCSS and CR-PCSS to qualify for 
re-treatment. 
Previously placebo-treated subjects will have the option to receive a second course of EN3835 in 
the same or different qualifying quadrant after at least 28 days following end of the first 
treatment course (ie treatment of second quadrant could begin on day 71 after treating the first 
quadrant). The selected quadrant can be re-treated or re-dosed.  
At each treatment session visit, Investigators will select the dimples within the chosen quadrant 
to be treated. Selection of dimples to be treated in the quadrant will be at the discretion of the 
Investigator. The selected EFP dimples in the selected quadrant must be well-defined and evident 
when the subject is standing in a consistent relaxed pose (without the use of any manipulation 
such as skin pinching or muscle contraction). The dimples selected to be treated will be circled 
with a surgical marker and injection site locations should be marked with a dot; if more than 1 
injection per dimple is needed, the injection sites should be separated by approximately 2 cm. 
The selected quadrant will be photographed again after marking dimples. Subjects will be 
administered a maximum of EN3835 0.84 mg from a total of up to 12 injections. Up to 12 
injections will be administered at each treatment session to treat the selected quadrant. Each of 
the injections will be administered as three 0.1-mL aliquots (total injection volume per injection 
is 0.3 mL; total injection volume per treatment session is 3.6 mL [12 injections × 0.3 mL], see 
table below).  
Subjects will receive 3 treatment sessions (day 1, day 22, and day 43) unless the chosen quadrant 
has no further treatable EFP dimples and the Investigator rates the quadrant a score of 0 on the 
CR-PCSS. The same dimples within a quadrant or different dimples within a quadrant may be 

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treated at each session but injections must all be within the selected quadrant for all 3 sessions. 
Each treatment session will be separated by approximately 21 days. 
Dose per 
Each Injectiona 
Injection 
Volume per 
Each Injection 
Maximum 
Number of 
Injections per 
Each Treatment 
Session 
Maximum Dose 
(mg) per Each 
Treatment 
Session 
Maximum 
Injection Volume 
(mL) per Each 
Treatment 
Session 
Maximum 
Cumulative EFP 
Dose 
EN3835 0.07 mg 
N=333 
0.3 mL 
12 injections  
0.84 mg 
(12 injections  
× 0.07 mg) 
3.6 mL 
(12 injections  
× 0.3 mL) 
2.52 mg 
(3 treatment sessions 
× 0.84 mg) 
a Each injection of EN3835 is 0.3 mL administered as three 0.1-mL aliquots.  
The complete Schedule of Events is provided in section 5 (Table 2 and Table 3) and summarized 
in section 12. 
10.2. 
Selection of Doses 
Maximum possible doses of EN3835 employed will be the same as that administered in the 
double-blind, placebo-controlled, parent study (EN3835-201). 
10.3. 
Study Drug Administration 
Study drug in the form of sterile vials of lyophilized EN3835 (formerly AA4500) and sterile 
diluent will be provided by Endo. Study drug administration at each injection site is presented in 
section 12.1.4.2. 
10.4. 
Discussion of Study Design, Including the Choice of Control Groups 
The use of the open-label extension design allows for the following: 
x Safety data over a 12-month period will be collected to assist in further defining the 
safety profile of EN3835 in this population, 
x Safety data and immunogenicity after repeat exposure (re-treatment/re-dosing) and 
monitoring of previously active-treated subjects to EN3835 over a 12-month period,  
x Previously placebo-treated subjects to have exposure to EN3835, and  
x Durability of the response to EN3835 (cellulite severity assessments) will be 
assessed.  

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11. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
11.1. 
Observation Phase 
All subjects who have completed the double-blind study EN3835-201, including all day 71 
assessments, and sign informed consent are eligible for enrollment in this open-label extension 
study and participation in the ongoing safety and cellulite evaluations.  
11.1.1. 
Subject Inclusion Criteria for Observation 
To qualify for this open-label observation study a subject must: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be willing to apply sunscreen to any treated quadrant before each exposure to the sun 
while participating in the study (ie, screening through end of study) 
11.1.2. 
Subject Exclusion Criteria for Observation 
None 
11.2. 
Treatment 
Inclusion and exclusion criteria presented in section 11.2 apply only to those subjects in the 
open-label study who choose treatment. 
At the time that the study drug blind is broken in the double-blind study EN3835-201, qualified 
subjects enrolled in the open-label study are eligible for treatment. A subject may participate in 
the observational period of this open-label study regardless of scoring of quadrant; however to 
receive treatment in this study, a subject must have at least 1 qualifying quadrant. 
11.2.1. 
Subject Inclusion Criteria for Treatment 
To qualify for treatment in the study a subject must: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be a female 8 years of age 
4. At Screening B visit, have at least 1 quadrant with: 
a. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 
b. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and 
c. a Hexsel CSS score no greater than 13 
5. Be willing to apply sunscreen to the selected treatment quadrant before each exposure to 
the sun while participating in the study (ie, Screening B through end of study) 
6. Be judged to be in good health, based upon the results of a medical history, physical 
examination, and laboratory profile at Screening B 

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7. Have a negative urine pregnancy test at Screening B and before injection of study drug 
and be using an effective contraception method (eg, abstinence, intrauterine device 
[IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at 
least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be 
menopausal defined as 12 months of amenorrhea in the absence of other biological or 
physiological causes, as determined by the Investigator; or post-menopausal for at least 
1 year; or be surgically sterile. 
8. Be willing and able to cooperate with the requirements of the study 
9. Be able to read, complete and understand the patient-reported outcomes rating 
instruments in English 
11.2.2. 
Subject Exclusion Criteria for Treatment 
A subject will be excluded from treatment in the study (but not from the observation 
assessments) if she: 
1. Has used any of the following for the treatment of EFP on the legs or buttock within the 
timelines identified below or intends to use any of the following at any time during the 
course of the study: 
x Liposuction on the side of the body selected for treatment during the 12-month period 
before injection of study drug 
x Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or 
surgery (including subcision and/or powered subcision) within the selected treatment 
quadrant during the 12-month period before injection of study drug 
x Endermologie or similar treatments within the selected treatment quadrant during the 
6-month period before injection of study drug 
x Massage therapy within the selected treatment quadrant during the 3-month period 
before injection of study drug 
x Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected 
treatment quadrant during the 2-week period before injection of study drug 
2. Is presently nursing a baby or providing breast milk for a baby 
3. Intends to become pregnant during the study 
4. Has received an investigational drug or treatment within 30 days before injection of study 
drug 
5. Has a known systemic allergy to collagenase or any other excipient of study drug 
6. Is currently receiving or plans to receive anticoagulant or antiplatelet medication or has 
UHFHLYHGDQWLFRDJXODQWRUDQWLSODWHOHWPHGLFDWLRQH[FHSWIRU mg aspirin daily) 
within 7 days before injection of study drug 
7. Has a known recent history of stroke, bleeding, or other medical condition, which in the 
investigator’s opinion would make the subject unsuitable for enrollment in this phase of 
the study 

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11.3. 
Subject Discontinuation Criteria 
A premature discontinuation will occur when a subject who signed informed consent ceases 
participation in the study, regardless of circumstances, prior to the completion of the protocol. 
Subjects can be prematurely discontinued from the study for one of the following reasons: 
x An adverse event (AE) 
x A protocol violation (reason must be specified, for example: lack of compliance, use 
of a prohibited concomitant medication, failure to meet inclusion/exclusion criteria 
after study entry, etc) 
x Withdrawal by subject (reason must be specified) 
x The subject was “lost to follow-up”  
x Other reasons (reason must be specified, for example: the subject moved, pregnancy, 
investigator decision, Sponsor decision to terminate trial, etc) 
If a subject discontinues from the study, all end-of-study procedures should be conducted as 
detailed in Schedule of Events. The date a subject discontinues, the treatment, and the reason for 
discontinuation will be recorded in the source documentation and Electronic Case Report Form 
(eCRF). If, however, a subject withdraws consent, no end-of-study procedures are required 
except the collection of AE information. This information should be recorded in the source 
documentation and the eCRF.  
11.3.1. 
Replacement Procedures 
Subjects who discontinue prematurely from the study will not be replaced. 

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12. 
PROCEDURES AND TREATMENTS 
12.1. 
Study Visits 
The Schedule of Events to be performed at each visit is shown in section 5. Provided below are 
further details where additional instruction about the assessments that will be performed is 
deemed to be needed. 
12.1.1. 
Subject Screening 
Upon completion of day 71 assessments in the double-blind study EN3835-201, a subject will be 
eligible to enter this open-label extension study. Investigators will be expected to maintain a 
Screening Log of all potential study subjects. This log will include limited information about the 
potential subject and the date and outcome of the screening process (eg, enrolled into the study, 
reason for ineligibility, or refused to participate). Investigators will provide information about the 
study to subjects who appear to meet the criteria for participation in the study. 
12.1.2. 
Screening Assessments 
After obtaining informed consent, the full assessment of eligibility will be conducted and prior to 
study entry, screening assessments will be performed. Details about how the informed consent 
will be obtained and documented are provided in section 21.3, Subject Information and Consent. 
The subject may be entered into the observational phase of the study and complete safety and 
cellulite severity assessments at 3-month intervals as detailed in Table 2. In addition, once the 
study blind is broken in study EN3835-201, enrolled subjects will be asked if they wish to 
receive additional open-label treatments. If a subject elects to receive open-label treatment, study 
assessments will be conducted in accordance with Table 3. 
12.1.3. 
Study Entry/Observational Assessments 
A subject who gives written informed consent and who satisfies all eligibility criteria 
(section 11) may be entered into the observational phase of the study and complete safety and 
cellulite severity assessments at 3-month intervals as detailed in Table 2. In addition, once the 
study drug blind is broken in study EN3835-201, enrolled subjects will be asked if they wish to 
receive additional open-label treatments. If a subject elects to receive open-label treatment, study 
assessments will be conducted in accordance with Table 3. The subject identification number 
will be carried over from the double-blind, placebo-controlled study (EN3835-201). 
12.1.3.1. Three-Month Assessments 
Subjects will return within 20 days (±4 days) of completion of the double-blind study for the first 
of 4 safety and cellulite severity evaluation visits. Assessments to be completed at these visits are 
detailed in Table 2. Subjects are to return at 3-month intervals until they have completed 
12 months from day 1 of the double-blind study. At these visits, quadrant(s) previously treated 
with EN3835 in the EN3835-201 study or quadrants treated with EN3835 in the open-label study 
will be evaluated. If the quadrant treated in study EN3835-201 is retreated in the open-label 
study, the 3-month assessments will reset to treatment visit 1/day 1 of the open-label treatment 
and the study visits will continue as described in Table 3 followed by 3-month assessments as 

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described in Table 2. If a different quadrant is treated in the open-label study, the 3-month 
assessments of both the quadrant treated in the double-blind study (EN3835-201) and the 
quadrant treated in the open-label study will continue. 
12.1.4. 
Treatment Assessments (Optional) 
At the time of unblinding of treatment assignment in the EN3835-201 study, subjects are eligible 
for optional treatment in the open-label study, provided they meet the inclusion and exclusion 
criteria detailed in section 11 and at least 1 quadrant meets the criteria for treatment. A subject 
may receive a maximum of 2 courses of treatment (6 treatment sessions) overall (total of 
treatments in double-blind and open-label study). If a subject received placebo in the double-
blind study, she may be eligible for 2 treatments in the open-label study; if a subject received 
active drug in the double-blind study, she may be eligible for 1 additional treatment (3 treatment 
sessions) in the open-label study.  
Selection of Treatment Quadrant 
During the Screening B visit, each subject will have photographs taken of the 4 targeted 
quadrants of the study (eg, their left and right buttocks and left and right posterolateral thighs). 
Subjects will receive instructions (Appendix D) for using the PR-PCSS and will use the scale to 
rate the severity of their cellulite in each of the 4 quadrants by comparing each of their digital 
image photographs with the PR-PCSS instrument. This self-assessment will take place in a 
private setting to minimize any potential bias from site personnel (the Investigator is blinded to 
these scores). The Investigator will then assess each of the 4 subject’s quadrants live in real-time 
using the CR-PCSS. The Investigator will then examine each of the 4 quadrants live to assess the 
subject using the Hexsel CSS as described in section 13.1.1.6.(12) Subjects must have at least 
1 quadrant that meets the following criteria for treatment in the study: 
1. PR-PCSS score of 3 or 4, and 
2. CR-PCSS score of 3 or 4, and  
3. Hexsel CSS score no greater than 13.  
After the independent assessments are completed separately by the subject and the Investigator, 
the Investigator will review his/her assessments and the subject’s assessment to determine which 
quadrants, if any, are eligible. The eligible quadrants (must meet all 3 of the inclusion criteria 
(PR-PCSS, CR-PCSS, and Hexsel CSS scores), if any, for treatment will be determined by the 
Investigator after which the quadrant selected will be at the discretion of the subject. For subjects 
treated with EN3835 in the double-blind study, if the quadrant treated in the double-blind study 
(EN3835-201) has PR-PCSS and CR-PCSS ratings identical or more severe than the double-
blind study (EN3835-201) PR-PCSS and CR-PCSS baseline ratings (Baseline is day 1 of study 
EN3835-201), subjects can elect to have that same quadrant re-treated. Subjects who choose 
re-treatment of the previously treated quadrant will be classified in the re-treatment arm. If 
another quadrant besides the previously treated quadrant meets the all 3 of the inclusion criteria, 
subjects can choose to be treated in the naive quadrant. Subjects who choose treatment into a 
naive quadrant will be classified in the re-dosing arm. 

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Assessments made with the PR-PCSS (from digital image), the CR-PCSS (live assessment), and 
the Hexsel CSS score during the open-label Screening B visit will be the baseline severity of 
EFP in the selected quadrant.  
A subject who received placebo in the double-blind study may be treated in the same quadrant in 
the open-label study if the quadrant still meets all 3 criteria OR another qualifying quadrant may 
be selected for treatment by the Investigator and subject. Following day 71 of a treatment course 
(3 treatment sessions), subjects can choose to receive a second treatment session in either the 
same quadrant if it still meets qualification criteria or in a different quadrant that meets 
qualification criteria. For the first treatment session, these subjects will be considered in the 
treatment arm. For the second treatment session, if the same quadrant is treated, subjects will be 
in the re-treatment arm; if a different quadrant is treated, subjects will be considered in the 
re-dosing arm.  
If no quadrant meets all 3 criteria, the subject may continue in the observation-only study with 
safety and cellulite severity evaluations performed at 3-month intervals but may not receive 
treatment in this study. 
Selecting and Marking Dimples 
Selection of dimples to be treated in the selected quadrant is at the discretion of the Investigator 
or qualified designee. Dimples must be well-defined and evident when the subject is standing in 
a consistent relaxed pose (without the use of any manipulation such as skin pinching or muscle 
contraction). Each subject will receive 3 treatment sessions of study drug in the selected 
quadrant. During each treatment session, the treatment quadrant will be photographed before and 
after dimple marking while the subject is standing in a consistent relaxed pose as described in the 
Photography Manual. The cellulite severity assessments using the PR-PCSS, CR-PCSS, and 
Hexsel CSS will be completed prior to dimple marking at treatment visits 2, 3, and 4/end of 
treatment. 
12.1.4.1. Screening B (Days í14 to í1 Relative to Open-Label Treatment Visit Day 1) 
Subjects meeting the relevant criteria listed in section 11.2 may be eligible for treatment in the 
open-label study. The following procedures will be performed and documented during the 
screening period: 
1. Evaluate eligibility based on inclusion/exclusion criteria (section 11.2) 
2. Subject will have digital photographs taken of the 4 targeted quadrants of the study (left 
and right buttocks, and left and right posterolateral thighs) (section 13.1) 
3. Subjects will get instruction on the use of the PR-PCSS (Appendix D) 
4. Subjects will rate each quadrant using the PR-PCSS while viewing their digital images 
(section 13.1.1.1) 
5. The Investigator will conduct live assessments of subject’s cellulite severity of each 
quadrant using the CR-PCSS (section 13.1.1.4) 
6. The Investigator will conduct live cellulite evaluation of each quadrant using the Hexsel 
CSS (section 13.1.1.6).  

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7. If at least 1 quadrant qualifies based on PR-PCSS, CR-PCSS, and Hexsel CSS ratings, 
subject may return for treatment on treatment visit 1. If none of the 4 quadrants qualify, 
the subject may remain in the study and have safety and cellulite severity evaluations 
performed at 3-month intervals but is not eligible for treatment. 
8. Subject will select an eligible quadrant (based on qualifying scores) to be treated at their 
discretion. 
9. Medical history including EFP history. Medical history will be based on EN3835-201 
eCRF; only updates to the history need to be captured at Screening B visit. 
10. Record prior and concomitant medications/procedures. Prior medications will be based 
on EN3835-201 eCRF; only updates and concomitant medications need to be captured at 
Screening B visit (section 12.2). 
11. Physical examination including measurement of body weight and height (section 14.10)  
12. Vital sign measurements (section 14.8) 
13. 12-lead electrocardiogram (ECG), not necessary if the date of the ECG obtained during 
the double-blind study (EN3835-201) is within 12 months of the date of the Screening B 
visit (section 14.9) 
14. Collection of samples for: 
a. Clinical laboratory testing including Anti-AUX-I and anti-AUX-II antibody testing 
(section 14.7) 
b. Urine pregnancy testing (section 14.7) 
15. Adverse events (section 14) 
12.1.4.2. Treatment Session 1 (Visit 1B)  
Pre-injection 
1. Confirm eligibility criteria (section 11) 
2. Take digital photography of selected quadrant before dimple marking (section 13.1) 
3. Record concomitant medications/procedures (section 12.2) 
4. Vital sign measurements (section 14.8)  
5. Collection of samples for urine pregnancy testing (section 14.7) 
6. Select and mark dimples to be treated (section 12.1.4) 
7. Take digital photograph of selected quadrant after dimple marking (section 13.1) 
Injection 
Administration of study drug in the prone position (see below) 
Post-injection 
1. Record number of dimples treated and number of injections administered 

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2. Vital sign measurements (section 14.8) 
3. Injection site reactions and local tolerability 
4. Adverse events (section 14) 
The selected quadrant will be photographed before and after dimple marking while the subject is 
standing in a consistent relaxed pose as described in the Photography Manual. Before injection at 
treatment session 1, the Investigator or qualified designee will begin the session by selecting 
dimples within the chosen quadrant that are well defined, evident when the subject is standing, 
and suitable for treatment; treatment consists of up to 12 injections per session.. Because the goal 
of treatment is to improve the aesthetic appearance of the entire quadrant, the Investigator will be 
instructed to select dimples that in his or her opinion would most improve the aesthetic 
appearance of the entire quadrant. The same dimples within a quadrant or different dimples 
within a quadrant may be treated at each session but injections must all be within the selected 
quadrant for all 3 sessions. 
For each dimple selected for treatment, the Investigator or qualified designee will choose 
injection sites (injection sites within a dimple should be spaced approximately 2 cm apart, if a 
dimple requires more than 1 injection). Each injection site will be marked with a “dot” using a 
surgical marker. For round dimples, the “dot” will be placed in the center of the dimple; for 
elongated dimples, “dots” will be spaced out approximately 2 cm along the longer axis of the 
dimple. The Investigator or qualified designee will then use a surgical marker to circle each of 
the dimples selected for treatment. Circles in the selected quadrant should not overlap.  
Examples of subject dimple marking: 
Sample Thigh Marking 
Sample Buttock Marking 
Study Drug Administration at Each Injection Site 
See section 18.4 for study drug preparation. Study drug will be injected subcutaneously while the 
subject is in a prone position using a syringe with a 30-gauge ½-inch needle. Each injection site 
will receive a single skin injection of study drug administered as three 0.1-mL aliquots to 
Positions A, B and C (for a total injection volume of 0.3 mL) as shown in the following figure. 

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Care Procedures After Injection 
To evaluate the subject for possible immediate immunological AEs, the subject will remain in 
direct observation of medical personnel who are skilled in the management of an allergic 
reaction for 30 minutes after receiving the injection of study drug and until the subject exhibits 
no sign of an immunological or other clinically significant systemic or local AE. The subject’s 
vital signs should be stable before the subject can leave direct observation (see section 14.8).  
The Investigator or qualified designee will then apply a sterile dressing to the injection site with 
hypoallergenic tape. The subject will be instructed to remove the dressing in the evening.  
12.1.4.3. Treatment Session 2 (Visit 2/Day 22 ± 3 Days) and Treatment Session 3 
(Visit 3/Day 43 ± 3 Days) 
Pre-injection 
1. Record concomitant medications/procedures (section 12.2) 
2. Body weight measurements  
3. Vital sign measurements (section 14.8)  
4. Collection of samples for urine pregnancy testing (section 14.7) 
5. Digital photograph of selected quadrant before dimple marking (section 13.1) 
6. Subject assessment of the severity of cellulite using photograph of the selected quadrant 
via PR-PCSS (section 13.1.1.1). NOTE: Complete the subject (PR-PCSS) assessment 
before the Investigator (CR-PCSS) assessment and before dimple marking. 
7. Investigator live assessment of the severity of cellulite using the CR-PCSS 
(section 13.1.1.4) 
8. Selection and marking of dimples to be treated (section 12.1.4)  
9. Digital photograph after dimple marking (section 13.1)  
Injection 
Administration of study drug in the prone position (section 12.1.4.2) 
Post-injection 
1. Record number of dimples treated and number of injections administered 
2. Vital sign measurements (section 14.8) 
3. Injection site reactions and local tolerability  
4. AEs (section 14) 
If no injections are given at treatment session 2, subjects will still return for the day 43 visit and 
the selected quadrant will again be evaluated by the subject (PR-PCSS) and Investigator 
(CR-PCSS). If the Investigator rates the selected quadrant greater than 0 on the CR-PCSS, 
injections at treatment session 3 should be given. 

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Because the goal of treatment is to improve the aesthetic appearance of the entire quadrant, the 
Investigator will be instructed to select dimples that in his or her opinion would most improve 
the aesthetic appearance of the entire quadrant. The same dimples within a quadrant or different 
dimples within a quadrant may be treated at each session but injections must all be within the 
selected quadrant for all 3 sessions. Each subject will receive all 3 treatment sessions unless the 
selected quadrant has no treatable EFP dimples and the Investigator rates the quadrant a score of 
0 on the CR-PCSS.  
After the dimples are selected, the Investigator or qualified designee will again mark each 
injection site with a “dot,” and circle each dimple (circles should not overlap).  
12.1.4.4. Day 71 (±5 Days) End of Treatment/Early Termination 
The following procedures will be performed on Day 71: 
1. Record concomitant medications/procedures (section 12.2) 
2. Measurement of body weight  
3. Vital sign measurements (section 14.8)  
4. Collection of samples for: 
a. Clinical laboratory testing (section 14.7) 
b. Anti-AUX-I and anti-AUX-II antibody testing (section 14.7.1)  
5. Digital photograph of selected quadrant (section 13.1)  
6. Subject cellulite assessments of the selected quadrant using the photographic image 
(NOTE: complete subject cellulite assessments before Investigator cellulite assessments) 
using: 
a. PR-PCSS assessment (section 13.1.1.1) 
b. S-GAIS (section 13.1.1.2) 
c. Subject satisfaction with cellulite treatment assessment (section 13.1.1.3) 
7. Investigator cellulite assessments of selected quadrant using: 
a. CR-PCSS live assessment of subject (section 13.1.1.4) 
b. Hexsel CSS assessment of live subject while subject is standing in a relaxed position 
(section 13.1.1.6) 
c. I-GAIS (section 13.1.1.5) 
8. Injection site reactions and local tolerability 
9. AEs (section 14) 

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12.1.4.5. Follow-up Visits 
Following the day 71 visit, the quadrant(s) treated with EN3835 in the open label study will be 
evaluated every 3 months from the first exposure to EN3835 following the schedule in Table 2. 
The first follow-up visit will be approximately 20 days after the day 71 visit (ie approximately 
day 90 after treatment session 1). Follow-up visits will continue until the study is terminated 
when at least 100 subjects have been assessed at 12 months after the first exposure to EN3835. 
12.2. 
Prior and Concomitant Medications and Procedures 
All medications (including over-the-counter medications) taken by the subject at screening 
visit 1 through the end of the study must be recorded 
Additionally, any diagnostic, therapeutic or surgical procedures performed during the study 
period should be recorded including the date, indication for and description of the procedure.  
12.2.1. 
Prohibited Medications 
The following medications are prohibited for those subjects that elect to have treatment with 
study drug during the treatment phase of the study: anticoagulants (warfarin, heparin, direct 
thrombin inhibitors, Factor X inhibitors) and antiplatelet agents (aspirin >150 mg/day and P2Y12 
inhibitors, such as clopidogrel), which can cause additional bruising. However the use of aspirin 
DWDGRVHOHYHORIPJSHUGD\ZLOOEHSHUPLWWHGGXULQJWKHtreatment phase of the study. For 
those subjects in the observational-only phase of study, there are no prohibited medications: 
Table 5: 
Concomitant Medication Restrictions for Subjects During the Treatment 
Phase of Study 
Drug Class 
Restrictions 
Anticoagulants 
Subjects who elect treatment cannot take antiplatelet agents or 
DQWLFRDJXODQWVH[FHSWIRU mg aspirin daily) within 7 days before 
and after the dosing administration. 
12.2.2. 
Prohibited Procedures 
The treatments and procedures listed in exclusion criteria are prohibited during the study. 
12.3. 
Treatment Compliance  
All subjects who elect to have treatment will receive study drug administered by a clinician at the 
investigator’s site. 
Accidental or intentional overdoses should be reported to the Sponsor/designee promptly (see 
section 14.6.2). 
12.4. 
Blinding and Randomization 
This study will be conducted as an open-label investigation; no blinding of assigned treatment 
will occur. 

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12.5. 
End of Study 
The end of study is when 100 subjects complete the 1-year safety and cellulite severity 
evaluations. At the time of study termination, ongoing subjects receiving treatment will be 
followed through the day 71 visit. The remaining enrolled subjects (in excess of the first 
100 subjects to complete 1 year) will undergo early termination procedures in accord with the 
Schedule of Events (section 5). 
 

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13. 
ASSESSMENT OF EFFICACY 
13.1. 
Primary Efficacy Measurements 
Although measures of efficacious drug effect (ie, durability of improvement) will be made 
during the observation phase before the study drug blind is broken in the double-blind study 
(EN3835-201), and thereafter to the end of study, emphasis is on the assessment of safety over 
12 months after exposure to EN3835. Cellulite severity assessments will be made at scheduled 
intervals for both observation-only subjects (not receiving EN3835) as well as subjects who 
choose re-dosing or re-treatment with EN3835. 
Digital Photography: Digital photography will be utilized to assess certain cellulite severity 
parameters at specific intervals (see Schedule of Events, Table 2) for subjects in the observation-
only group as well as those electing to be re-treated or re-dosed with EN3835. At the 
Screening B visit for subjects electing to receive re-dosing or re-treatment, the Investigator or 
qualified designee will photograph each quadrant using a Sponsor-supplied standardized digital 
camera. The subject will be standing for each photography session and will be wearing a 
standardized photographic garment as described in the Photography Manual. The Investigator or 
qualified designee will photograph the selected quadrant as follows: 
x Screening B (no dimple marking)  
x Before and after dimple marking (prior to injections) on days 1, 22, and 43 of each 
treatment course 
x During the day 71 visit (end of treatment phase/early termination) of each treatment 
course 
All photographs from this study are the property of Endo and may be utilized for clinical 
development, scientific communication, marketing, regulatory purposes, and/or legal 
applications as required/desired by Endo. 
13.1.1. 
Subject and Investigator Cellulite Assessments 
As in the double-blind parent study, Investigator cellulite assessments are independent of the 
subject assessments. Therefore, all subject cellulite assessments must be completed before the 
Investigator’s cellulite assessments are made. After both the subject’s and investigator’s 
assessments are completed, the subject’s assessments will be revealed and compared to the 
clinician’s assessments to determine eligible quadrants. If more than 1 quadrant is eligible, the 
subject will select one for treatment. 
13.1.1.1. Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) 
The PR-PCSS will be conducted for the purpose of assessing the severity of cellulite in the 
buttock or thigh; there are separate scales for buttocks or thighs. The scales are 5-level 
photonumeric scales developed specifically for patients and used by the subject to assess the 
severity of their cellulite in the quadrants by viewing digital images of each of their quadrants 
captured by photography at the visit; the ratings range from 0 (None) to 4 (Severe) with labels 
and descriptors to aid the subject in the assessments.  

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All subjects who enter the observation-only phase of the study will have the PR-PCSS evaluation 
at months 3, 6, 9, and 12. 
For subjects electing re-treatment or re-dosing after the study drug blind is broken in study 
EN3835-201, a Screening B visit (Baseline) within 14 days before dosing day 1 will occur. 
Subjects will have digital photographs taken of all 4 quadrants as done in the double-blind trial 
for qualifying purposes. Subjects will then perform the PR-PCSS for both buttocks (Figure 1) 
and thighs (Figure 2) and will be reminded of their proper use (Appendix D).  
At the beginning of visits on days 22, 43, and 71; digital photographs of the selected quadrant 
will be taken. If the buttock is the treated region, subjects will be given the PR-PCSS for the 
buttock to use to make their evaluation; if the thigh is the treated region, subjects will be given 
the PR-PCSS for the thigh to make their evaluation.  
 

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Figure 1: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the Buttock 
 

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Figure 2: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the Thigh 

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13.1.1.2. Subject Global Aesthetic Improvement Scale (S-GAIS) 
Subjects in the observation-only group will complete the S-GAIS as described below at the final 
study visit (month 12 or early termination) using the pre-treatment day 1 image (Baseline) of the 
assigned quadrant in the double-blind study for comparison. 
The S-GAIS assessment will be done on day 71 of the treatment course and then at month 12 or 
the final study visit and compared back to the pre-dosing Screening B image (Baseline for 
treatment subjects) of the selected quadrant. All treated subjects will be instructed to answer the 
following question: How would you rate the appearance of your treated cellulite after 
treatment? 
The S-GAIS assessment will occur after the subject has completed the PR-PCSS assessment to 
avoid introducing potential bias to the static PR-PCSS assessment. Each subject will view the 
pre-dosing Screening B visit digital image alongside their day 71 treatment course visit and 
month 12 or end of study visit digital image of their selected quadrant to aid in the assessment 
(Table 6). Subjects will circle the rating below that best represents their answer. 
Table 6: 
Subject Global Aesthetic Improvement Scale (S-GAIS) 
Rating 
Response Option 
Description 
+3 
Very much improved 
My treated cellulite looks very much better. 
+2 
Much improved 
My treated cellulite looks much better, but additional treatment 
would slightly improve the result. 
+1 
Improved 
My treated cellulite looks better, but additional treatment is 
necessary. 
0 
No change 
My treated cellulite looks essentially the same as it did 
originally. 
í1 
Worse 
My treated cellulite looks worse than it did originally. 
í2 
Much worse 
My treated cellulite looks much worse than it did originally. 
í3 
Very much worse 
My treated cellulite looks very much worse than it originally. 
13.1.1.3. Subject Satisfaction with Cellulite Treatment Assessment 
For observation-only subjects (not receiving EN3835) the subjects will assess their satisfaction 
with cellulite treatment at the 12 month or end of study visit by being instructed to answer the 
following question: Today, how satisfied are you with the results of the cellulite treatment you 
received on the specific area or areas on your buttocks or thighs that were treated? Subjects will 
circle the rating in the below table that best represents their answer. 
For subjects who have elected to receive EN3835 either through re-treatment or re-dosing, the 
subject satisfaction with the cellulite treatment (Table 7) with be done at the treatment course 
day 71 and the month 12 visit or end of study visit. Subjects will be instructed to answer the 
following question: Today, how satisfied are you with the results of the cellulite treatment you 
received on the specific area or areas on your buttocks or thighs that were treated? Subjects will 
circle the rating below that best represents their answer. 

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Table 7: 
Subject Satisfaction with Cellulite Treatment Assessment 
Rating 
Description 
+2 
I am very satisfied with the cellulite treatment on my buttocks or thighs. 
+1 
I am satisfied with the cellulite treatment on my buttocks or thighs. 
0 
I am neither dissatisfied nor satisfied with the cellulite treatment on my buttocks or thighs. 
í1 
I am dissatisfied with the cellulite treatment on my buttocks or thighs. 
í2 
I am very dissatisfied with the cellulite treatment on my buttocks or thighs. 
13.1.1.4. Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 
The CR-PCSS will be conducted for the purpose of assessing the severity of cellulite in the 
buttock or thigh; there are separate scales for buttocks or thighs. The scales are 5-level 
photonumeric scales developed specifically for clinicians and used by the investigator to assess 
the severity of the subject’s cellulite in the quadrants by live assessments of the subject’s 
quadrant(s); the ratings range from 0 (None) to 4 (Severe) with labels and descriptors to aid the 
investigator in the assessments.  
Investigators will have been trained on the use of the CR-PCSS. For observation-only subjects, 
the CR-PCSS will be done at 3, 6, 9, and 12 months or at the end of study visit. 
For subjects who elected to receive EN3835 after the study drug blind is broken in study 
EN38325-201 as a re-treatment or re-dosing, the Investigator, at the Screening B visit (Baseline) 
will determine severity of cellulite of the 4 quadrants by assessing live subjects using the 
CR-PCSS for buttock (Figure 3) and thighs (Figure 4) after the subject has completed their self-
assessment using the PR-PCSS. The eligible quadrant chosen for injection will be at the 
discretion of the subject. Before injections on treatment visit days 22 and 43 and on visit day 71; 
Investigators will evaluate the selected quadrant by live assessments. If the buttock is the treated 
region, the Investigator will be use the CR-PCSS for the buttock to make their evaluation; if the 
thigh is the treated region, the Investigator will use the CR-PCSS for the thigh to make their 
evaluation. In each case, the Investigator will make his/her assessment independently and after 
the subject has conducted their self-assessment using the PR-PCSS. 
 

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Figure 3: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for the Buttock 
 

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Figure 4: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for the Thigh 
 
 

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13.1.1.5. Investigator Global Aesthetic Improvement Scale (I-GAIS) 
Investigators will complete the I-GAIS on subjects in the observation-only group as described 
below at the final study visit (month 12 or early termination) and a comparison back to the 
pre-treatment day 1 (Baseline) image of the assigned quadrant of the double-blind study. 
On day 71 of the treatment course and the 12 month or end of study visit, the Investigator will 
determine the degree of improvement from the Screening B digital image of the selected 
quadrant by comparing the cellulite in live assessment on day 71 and at month 12 or study end to 
the Screening B pre-treatment (Baseline) image of the subject’s selected quadrant (Table 8). The 
I-GAIS assessment will occur after the CR-PCSS assessment (section 13.1.1.4) to avoid 
introducing potential bias to the static CR-PCSS assessment by the Investigator at the site. The 
Investigator will circle the rating below that best represents their answer. 
Table 8: 
Investigator Global Aesthetic Improvement Scale (I-GAIS) 
Rating 
Response Option 
Description 
+3 
Very much improved 
Optimal cosmetic result from treatment of the treated dimples 
+2 
Much improved 
Marked improvement in the treated area appearance from 
before treatment, but not completely optimal 
+1 
Improved 
Obvious improvement in the treated area appearance from 
before treatment, but additional treatment is indicated 
0 
No change 
The treated area appearance is essentially the same as before 
treatment 
í1 
Worse 
The treated area appearance is worse than before treatment 
í2 
Much worse 
Marked worsening in appearance from the initial condition 
í3 
Very much worse 
Obvious worsening in appearance from the initial condition 
13.1.1.6. Hexsel Cellulite Severity Scale 
The Hexsel Cellulite Severity Scale (referred to as the Hexsel CSS) is a photonumeric scale that 
looks at 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of 
depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or 
sagging of skin, and (E) current classification scale based on medical literature including 
Nürnberger and Müller.(12,13) Each of these features is evaluated on a 4-point scale from a low 
of 0 to a high of 3 as described in Table 9 (see Appendix B). The total score is the summation of 
all 5 features. 
For subjects in the observation-only group, the Hexsel CSS will be done at month 3 and every 
3 months thereafter and at the month 12 or the end of study visit. 
For subjects who elected to have EN3835 treatments, the Hexsel CSS will be done at 3-month 
intervals during the observation phase until the study drug blind is broken in study EN3835-201. 
The Hexsel CSS assessment will be done at Screening B visit and on day 71 of the treatment 
course and at month 12 or end of study visit. 
For the subjects electing treatment (re-treatment or re-dosing) with EN3835 the Investigator or 
qualified designee will use the Hexsel CSS to assess the severity of EFP in all quadrants at 

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Screening B and the selected quadrant on day 71 of the course of treatment. All cellulite 
assessments should be made while the subject is in the standing position with relaxed gluteus 
muscles. However, when evaluating the subject for Category E (classification scale by 
Nürnberger and Müller) (13) if the subject has no evident depressions, the subject should be 
asked to contract her gluteus muscles or the pinch test should be applied (by pinching the skin 
between the thumb and index finger) so the Investigator or qualified designee can differentiate 
between scores/grades of zero (0) or I. 
Table 9: 
Hexsel Cellulite Severity Scale 
A 
Number of evident depressions 
0=none/no depressions 
1=a small amount: 1-4 depressions are visible 
2=a moderate amount: 5-9 depressions are visible 
3=a large amount: 10 or more depressions are visible 
B 
Depth of depressions 
0=no depressions 
1=superficial depressions 
2=medium depth depressions 
3=deep depressions 
C 
Morphological appearance of skin 
surface alterations 
0=no raised areas 
1=‘orange peel’ appearance 
2=‘cottage cheese’ appearance 
3=‘mattress’ appearance 
D 
Grade of laxity, flaccidity, or sagging 
skin 
0=absence of laxity, flaccidity, or sagging skin 
1=slight draped appearance 
2=moderate draped appearance 
3=severe draped appearance 
E 
Classification scale by Nürnberger and 
Müllera 
0 = zero grade = Grade or Stage 0 = There is no alteration of the 
skin surface. 
1 = first grade = Grade or Stage I = The skin of the affected area 
is smooth while the subject is standing or lying, but the 
alterations to the skin surface can be seen by pinching the skin 
or with muscle contraction. 
2= second grade = Grade or Stage II = The orange skin or 
mattress appearance is evident when standing, without the use 
of any manipulation (skin pinching or muscle contraction). 
3= third grade = Grade or Stage III = The alterations described 
in Grade or Stage II, are present together with raised areas and 
nodules. 
Source: Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad 
Dermatol Venereol. 2009;23(5):523-528. 
a Subjects should be evaluated in the standing position with relaxed gluteus muscles. However, if the subject has no 
evident depressions, they should be asked to contract their gluteus muscles or the pinch test should be applied (by 
pinching the skin between the thumb and index finger) in order to differentiate between grade/stage of zero (0) 
or I. 
 

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14. 
ASSESSMENT OF SAFETY 
14.1. 
Definitions 
14.1.1. 
Adverse Event 
An adverse event (AE) is any unfavorable or unintended change in body structure (signs), body 
function (symptoms), laboratory result (eg, chemistry, ECG, X-ray, etc), or worsening of a pre-
existing condition associated temporally with the use of the study medication whether or not 
considered related to the study medication. AEs will be captured once a subject has signed the 
informed consent. AEs include: 
x Changes in the general condition of the subject 
x Subjective symptoms offered by or elicited from the subject 
x Objective signs observed by the Investigator or other study personnel 
x All concurrent diseases that occur after the start of the study, including any change in 
severity or frequency of pre-existing disease 
x All clinically relevant laboratory abnormalities or physical findings that occur during 
the study 
A treatment-emergent adverse event (TEAE) is any condition that was not present prior to 
treatment with study medication but appeared following treatment, was present at treatment 
initiation but worsened during treatment, or was present at treatment initiation but resolved and 
then reappeared while the individual was on treatment (regardless of the intensity of the AE 
when the treatment was initiated).  
All AEs, including both observed or volunteered problems, complaints, signs or symptoms must 
be recorded on the AE page of the eCRF, regardless of whether associated with the use of study 
medication. This would include AEs resulting from concurrent illness, reactions to concurrent 
medication use, or progression of disease states (excluding the disease under study). A condition 
present at baseline that worsens after initiation of study treatment will be captured as an AE; the 
onset date will be the date the event worsened. The AE should be recorded in standard medical 
terminology when possible. 
14.1.2. 
Serious Adverse Event 
A serious adverse event (SAE) is defined as an AE that: 
x Results in death 
x Is immediately life-threatening (there is an immediate risk of death from the AE as it 
occurred; this does not include an AE that had it occurred in a more serious form may 
have caused death) 
x Results in or prolongs an inpatient hospitalization (Note: a hospitalization for elective 
or pre-planned surgery, procedure, or drug therapy does not constitute an SAE)  

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x Results in permanent or substantial disability (permanent or substantial disruption of 
one’s ability to conduct normal life functions)  
x Is a congenital anomaly/birth defect (in offspring of a subject using the study 
medication regardless of time to diagnosis) 
x Is considered an important medical event 
Important medical events are defined as events that, based upon appropriate medical judgment, 
may jeopardize the subject and may require medical or surgical intervention to prevent one of the 
other serious outcomes. Examples of important medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions 
that do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse. 
14.2. 
Monitoring Adverse Events 
At each visit, subjects will be queried regarding any AEs that have occurred since the last visit. 
Subjects will be asked to volunteer information concerning AEs with a non-leading question 
such as, “How do you feel?” Study site personnel will then record all pertinent information in the 
source documents and the eCRF. The study drug compliance record should also be reviewed to 
detect potential overdoses (intentional/unintentional). 
14.3. 
Relationship to Study Drug 
The degree of “relatedness” of the AE to the study medication must be described using the 
following scale:  
x Not related indicates that the AE is definitely not related to the study medication. 
x Unlikely related indicates that there are other, more likely causes and study 
medication is not suspected as a cause. 
x Possibly related indicates that a direct cause and effect relationship between study 
medication and the AE has not been demonstrated, but there is evidence to suggest 
there is a reasonable possibility that the event was caused by the study medication. 
x Probably related indicates that there is evidence suggesting a direct cause and effect 
relationship between the AE and the study medication. 
It is the Sponsor’s policy to consider “Probably related” and “Possibly related” causality 
assessments as positive causality. “Not related” and “Unlikely related” causality assessments are 
considered as negative causality. 
Assessments will be recorded on the eCRF and must indicate clearly the relationship being 
assessed. For example, an AE that appears during a placebo run-in phase would be assessed with 
respect to the placebo treatment received and/or study procedures conducted during this phase. If 
the AE continued into an active treatment phase, the relationship would be assessed for the active 
treatment phase only if the AE worsened.  

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14.4. 
Intensity Assessment 
The intensity (or severity) of AEs is characterized as mild, moderate, or severe: 
x Mild AEs are usually transient, requiring no special treatment, and do not interfere 
with the subject’s daily activities. 
x Moderate AEs introduce a low level of inconvenience or concern to the subject and 
may interfere with daily activities, but are usually ameliorated by simple therapeutic 
measures. 
x Severe AEs interrupt a subject’s usual daily activity and typically require systemic 
drug therapy or other treatment. 
When the intensity category of an AE changes, the greatest intensity during that continuous 
episode should be recorded.  
14.5. 
Reporting Adverse Events and Serious Adverse Events 
14.5.1. 
Reporting Adverse Events 
Throughout the study, AEs will be documented on the source document and on the appropriate 
page of the eCRF whether or not considered treatment-related. This includes any new signs, 
symptoms, injury or illness, including increased severity of previously existing signs, symptoms, 
injury, or illness. Conditions existing prior to screening will be recorded as part of the subject’s 
medical history. The Investigator is responsible for assessing the relationship of AEs to the study 
medication; relationship will be classified as not related, unlikely related, possibly related, or 
probably related.  
All AEs will be collected by the Investigator from the time of signing the informed consent 
through 30 days after the last dose of study medication; this includes any AEs that are ongoing at 
the time of completion/termination of the study. All ongoing AEs must be followed until 
resolution or for 30 days after the subject’s last study visit, whichever comes first. 
14.5.2. 
Reporting Serious Adverse Events 
Any SAE, including death resulting from any cause, which occurs to any subject participating in 
this study must be reported via email or fax by the Investigator using the Endo Clinical Trial 
Report Form for SAEs within 24 hours of first becoming aware of the SAE. SAEs will be 
collected by the Investigator from the time of signing the informed consent through 30 days after 
the last dose of study medication. SAEs that occur within 30 days, following cessation of the 
study treatment, or within 30 days, following premature discontinuation from the study for any 
reason, must also be reported within the same timeframe. Any SAE that is felt by the Investigator 
to be related to the study medication must be reported regardless of the amount of time since the 
last dose received. Follow-up information collected for any initial report of an SAE must also be 
reported to the Sponsor within 24 hours of receipt by the Investigator.  
All SAEs will be followed until resolution, stabilization of condition, or until follow-up is no 
longer possible. 

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In the event discussion is necessary regarding treatment of a subject, call the Medical 
Monitor (see contact information in section 3). 
All SAEs should be sent via the email address, or faxed to the fax number, provided in 
section 3. 
The Sponsor will determine whether the SAE must be reported within 7 or 15 days to regulatory 
authorities in compliance with local and regional law. If so, the Sponsor (or the Sponsor’s 
representative) will report the event to the appropriate regulatory authorities. The Investigator 
will report SAEs to the institutional review board (IRB) per their IRB policy. 
14.5.2.1. Follow-up Procedures for Serious Adverse Events 
To fully understand the nature of any SAE, obtaining follow-up information is important. 
Whenever possible, relevant medical records such as discharge summaries, medical 
consultations, and the like should be obtained. In the event of death, regardless of cause, all 
attempts should be made to obtain the death certificate and any autopsy report. These records 
should be reviewed in detail, and the Investigator should comment on any event, lab 
abnormality, or any other finding, noting whether it should be considered a serious or 
non-serious AE, or whether it should be considered as part of the subject’s history. In addition, 
all events or other findings determined to be SAEs should be identified on the follow-up SAE 
form and the Investigator should consider whether the event is related or not related to study 
drug. All events determined to be nonserious should be reported on the eCRF. 
14.6. 
Special Reporting Situations 
14.6.1. 
Adverse Events of Special Interest 
There are no AEs of special interest anticipated in this study. AEs such as bruising, ecchymosis, 
hematomas, and contusions that occur remote to the site of drug administration will be recorded 
as an AE or SAE as appropriate (see section 14.1.1, Adverse Events or section 14.1.2, Serious 
Adverse Events). 
14.6.2. 
Overdose/Misuse/Abuse 
Study drug overdose is any accidental or intentional use of study drug in an amount higher than 
the dose indicated by the protocol for that subject. Study drug compliance (see section 12.3) 
should be reviewed to detect potential instances of overdose (intentional or accidental). 
Any study drug overdose during the study should be noted on the study medication eCRF.  
An overdose is not an AE per se, however all AEs associated with an overdose should both be 
entered on the Adverse Event eCRF and reported using the procedures detailed in section 14.5.2, 
Reporting of Serious Adverse Events, even if the events do not meet seriousness criteria. If the 
AE associated with an overdose does not meet seriousness criteria, it must still be reported using 
the Endo Clinical Trial Report Form for SAEs and in an expedited manner, but should be noted 
as non-serious on the form and the Adverse Event eCRF. 

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14.6.3. 
Pregnancy 
Any uncomplicated pregnancy that occurs in a subject during this clinical study will be reported 
for tracking purposes only. All subject pregnancies that are identified during or after this study, 
where the estimated date of conception is determined to have occurred during study drug therapy 
or within 30 days of the last dose of study medication need to be reported, followed to 
conclusion, and the outcome reported, even if the subject is discontinued from the study. The 
investigator should report all pregnancies within 24 hours using the Initial Pregnancy Report 
Form, and any pregnancy-associated SAE using the SAE report form, according to the usual 
timelines and directions for SAE reporting provided in section 14.5.2. Monitoring of the 
pregnancy should continue until conclusion of the pregnancy; 1 or more Follow-up Pregnancy 
Report Form(s) detailing progress, and a Two Month Follow-up Pregnancy Report Form 
detailing the outcome, should be submitted. 
Pregnancy itself is not regarded as an AE unless there is suspicion that the investigational 
product under study may have interfered with the effectiveness of a contraceptive medication. 
Likewise, elective abortions without complications are not considered AEs. Any SAEs 
associated with pregnancy (eg, congenital abnormalities/birth defects/spontaneous miscarriages 
or any other serious events) must additionally be reported as such using the SAE report form. 
Spontaneous miscarriages should also be reported and handled as SAEs.  
Subjects should be instructed to immediately notify the investigator of any pregnancies. 
Attempts to obtain the pregnancy follow-up and pregnancy outcome information detailed above 
are necessary even if a subject discontinues treatment because of pregnancy. 
14.6.4. 
Adverse Events/Serious Adverse Events Experienced by Non-subjects Exposed 
to Study Medication 
Non-subjects are persons who are not enrolled in the study but have been exposed to study 
medication, including instances of diversion of study medication. All such AEs/SAEs occurring 
in non-subjects from such exposure will be reported to the Endo Pharmacovigilance and Risk 
Management (PVRM) Department (when the non-subject agrees) on the departmental form for 
SAEs regardless of whether the event is serious or not. Instructions for completing the form for 
events experienced by non-subjects will be provided. SAEs occurring in non-subjects exposed to 
study medication will be processed within the same SAE reporting timelines as described in 
section 14.5.2, Serious Adverse Event Reporting. Additionally, the drug accountability source 
documentation at the site should reflect this occurrence. 
14.7. 
Clinical Laboratory and Immunogenicity Determinations 
Clinical laboratory tests will be conducted according to the Schedule of Events (section 5). 
Clinical laboratory tests will be performed by a designated central laboratory. Each site will be 
provided with instructions on specimen collection, preparation, packaging and transport. Refer to 
the central laboratory manual for further information regarding sample collection, handling, and 
labeling. The results of the tests will be returned to the investigational sites.  
Clinical laboratory test data will be reviewed by the investigator, or designee, and additional 
clinical laboratory tests may be ordered at his/her discretion (eg, if the results of any clinical 
laboratory test falls outside the reference range or clinical symptoms necessitate additional 

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testing to ensure safety). Any additional testing will be performed by the designated central 
laboratory. 
The investigator will review all abnormal lab results for clinical significance. Any abnormal 
clinical laboratory test result meeting the investigator’s or Sponsor’s criteria for clinical 
significance (refer to central laboratory manual) will be recorded as an AE or SAE as appropriate 
(see section 14.1.1, Adverse Events or section 14.1.2, Serious Adverse Events). 
Laboratory results will be sent electronically to Endo for data management. 
Clinical laboratory parameters that will be measured in this study are listed in Table 10. 
Table 10: 
Clinical Laboratory Parameters 
Hematology 
Clinical Chemistry 
Urinalysis 
Hematocrit 
Hemoglobin 
Red blood cell count 
Red blood cell morphology 
White blood cell count 
Neutrophils 
Lymphocytes 
Monocytes 
Basophils 
Eosinophils 
Platelets 
Blood urea nitrogen 
Creatinine 
Total bilirubin 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Alkaline phosphatase 
Sodium 
Potassium 
Calcium 
Chloride 
Phosphate 
Serum bicarbonate 
Uric acid 
Total cholesterol 
Total protein 
Glucose 
Triglycerides 
Albumin 
Specific gravity 
Ketones 
pH 
Protein 
Blood 
Glucose 
Female subjects of childbearing potential must have a negative urine pregnancy test at 
Screening B and at treatment visits 1, 2, and 3 (section 5) to receive treatment in the study. If 
necessary, additional urine pregnancy tests can be performed at any time during the study at the 
discretion of the Investigator. Urine pregnancy test kits will be supplied by the Sponsor. 
14.7.1. 
Anti-AUX-I and Anti-AUX-II Antibodies 
Serum samples will be collected and may be tested for binding and neutralizing anti-AUX-I and 
anti-AUX-II antibodies at visit 1 through visit 4. Additionally, if a subject consents to treatment 
in the open-label study, serum samples for antibody testing will be collected before injection at 
treatment visits 1, 2, 3, and 4 of the open-label treatment period. A subset of subject samples will 
have neutralizing antibodies tested from day 1 and day 71 visits; additional samples may be 
analyzed if results or clinical signs warrant testing.  
The serum samples obtained will be processed, stored and then shipped on dry ice to the 
designated central clinical laboratory before forwarding to Endo’s appointed laboratory for the 
determination of anti-AUX-I and anti-AUX-II antibodies according to the Laboratory Manual.  

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14.8. 
Vital Signs 
Vital sign measurements will be documented as described in the Schedule of Events. These 
parameters include pulse rate, respiratory rate, systolic and diastolic blood pressure, and body 
weight. Pulse and blood pressure readings will be taken after the subject has been sitting for 
5 minutes. Height should only be recorded at Screening B.  
The investigator will review all vital sign values for clinical significance. Any vital sign value 
meeting the investigator’s or Sponsor’s criteria for clinical significance will be recorded as an 
AE or SAE as appropriate (see section 14.1.1, Adverse Events, and section 14.1.2, Serious 
Adverse Events). 
For subjects receiving treatment, vital signs will be assessed at the time points shown in Table 11 
after the subject has rested for at least 5 minutes.  
Table 11: 
Vital Signs Measurements on Injection Day 
Time Point Relative to Last Injection 
Blood Pressure, Respiratory 
Rate, and Pulse Rate 
Body Temperature 
Up to 4 hours (before treatment) 
X 
X 
Approximately 15 minutes after 
X 
 
Approximately 30 minutes after 
X 
X 
14.9. 
Electrocardiogram 
Performing a 12-lead electrocardiogram (ECG) is not necessary if Screening B visit date is 
within 12 months of obtaining an ECG during the double-blind study (EN3835-201).  
If the date of Screening B visit is later than 12 months since obtaining the ECG in study 
EN3835-201, subjects will have a resting 12-lead ECG performed during the Screening B visit. 
A qualified physician will interpret, sign, and date the ECGs. Electrocardiogram assessments 
must be “within normal limits” or interpreted as “abnormal, not clinically significant” for the 
subject to be included in the study. 
Any ECG result meeting the investigator’s or Sponsor’s criteria for clinical significance will be 
recorded as an AE or SAE as appropriate (see section 14.1.1, Adverse Events and section 14.1.2, 
Serious Adverse Events). 
14.10. 
Physical Examination 
Body weight will be collected as described in the Schedule of Events (section 5). If a subject 
desires treatment in the open-label study, a complete physical examination will be performed at 
Screening B. All examinations will be performed by a physician or health professional listed on 
the Form FDA 1572 and licensed to perform physical examinations. 
The investigator will review all physical exam findings for clinical significance. Any physical 
exam finding meeting the investigator’s or Sponsor’s criteria for clinical significance will be 
recorded as an AE or SAE as appropriate (see section 14.1.1, Adverse Events and section 14.1.2, 
Serious Adverse Events). 

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14.11. 
Other Safety Assessments 
Not applicable. 

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15. 
ASSESSMENT OF PHARMACOKINETICS 
Not applicable. 

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16. 
ASSESSMENT OF PHARMACODYNAMICS 
Not applicable. 

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17. 
STATISTICAL CONSIDERATIONS AND METHODS 
17.1. 
Determination of Sample Size 
It is estimated that approximately 95% of the 350 subjects randomized in study EN3835-201 will 
enroll in the current study for a sample size of 333. This sample size should be adequate to 
determine safety and cellulite assessments of EN3835 for subjects retreated in the same and in 
different quadrants. 
17.2. 
Subject Cohorts and Subject Populations 
Subjects will be classified into 1 of 4 different cohorts depending on where they receive the 
treatment of EN3835 in relation to where they received treatment in study EN3835-201. The 
4 cohorts are: 
1. Observational subjects only - subjects who received EN3835 in study EN3835-201 but do 
not receive any injections in the current study 
2. Re-treatment subjects - subjects who received EN3835 in study EN3835-201 and receive 
EN3835 in the current study in the same quadrant that was treated in the EN3835-201 
study. This will only be allowed for subjects who have baseline severity ratings in the 
current study at or worse than the baseline seen in study EN3835-201 for both the 
CR-PCSS and PR-PCSS of the quadrant.  
3. Re-dosing subjects - subjects who received EN3835 in study EN3835-201 and receive 
EN3835 in the current study in a quadrant different than the EN3835-treated quadrant in 
study EN3835-201. 
4. Initial treatment subjects - subjects who received placebo in study EN3835-201 and 
receive EN3835 in the current study. 
All efficacy and safety analyses will be done within the classified cohort. Durability of treatment 
effects defined as time period from injection to return to baseline cellulite severity ratings in a 
EN3835-treated quadrant will be determined for all subjects that were treated with EN3835 in 
either this study or study EN3835-201. 
17.2.1. 
Observational Population 
The Observational population includes all subjects treated with EN3835 in study EN3835-201 
who do not receive any treatment in the current study. The durability of a treatment effect and 
long-term safety analyses for subjects who receive no treatment in the EN3835-201 study will be 
performed using this population 
17.2.2. 
Safety Population 
The Safety population will include all subjects who receive at least 1 dose of EN3835 in the 
current study or in study EN3835-201. All safety analyses will be performed using this 
population. 

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17.2.3. 
Intent-to-Treat Population 
The Intent-to-Treat (ITT) population includes all subjects who enroll in the current study.  
17.2.4. 
Modified Intent-to-Treat Population 
The Modified Intent-to-Treat (mITT) population includes all subjects who receive at least 1 dose 
of EN3835 in the current study (EN3835-202) and have a baseline and at least 1 post-baseline 
assessment on both the CR-PCSS and PR-PCSS on the quadrant selected for treatment in the 
current study. All cellulite assessment analyses will be completed on this population. 
17.2.5. 
Per-Protocol Population 
The Per-Protocol population includes all subjects in the safety population who have no major 
protocol deviations. Major protocol deviations excluding subjects from this population will be 
determined at the protocol deviation assessment meeting prior to the database lock. If more than 
10% of the safety population is excluded from the per-protocol population, then all safety and 
cellulite evaluations will be repeated using the per-protocol population. 
17.3. 
Subject Disposition 
The number of subjects included in each study population will be summarized. The number and 
percentage of subjects completed and discontinued will be presented. Reasons for 
discontinuation as recorded on the eCRF will be summarized (number and percentage) for all 
subjects. 
17.4. 
Demographics and Other Baseline Characteristics 
Demographic and baseline characteristics, including age, race, and baseline values will be 
summarized for the Observational population, the Safety population, and the mITT population 
using descriptive statistics. The descriptive statistics will include frequency tables for all 
categorical response variables and number, mean, standard deviation, minimum, and maximum 
for all continuous variables.  
17.5. 
Efficacy Analyses 
Cellulite assessments (efficacy) include: 
x PR-PCSS: 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) (screening 
visit [Baseline], days 22, 43, and 71). Also will be done at day 90, day 180, day 270, 
and day 360/end of study visits for observational assessments. 
x CR-PCSS: 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) (screening 
[Baseline], days 22, 43, and 71). Also will be done at day 90, day 180, day 270, and 
day 360/end of study visits for observational assessments. 
x Investigator rating of cellulite severity using the total scores from the Hexsel CSS 
scale: scores can range from 0 to 15 (screening [Baseline] and day 71). Also will be 
done at day 90, day 180, day 270, and day 360/end of study visits for observational 
assessments. 

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x I-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) 
(day 71). Also done at day 360/end of study visit for observational assessments. 
x S-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much 
worse) (day 71). Also done at day 360/end of study visit for observational 
assessments. 
x Subject satisfaction with cellulite treatment assessment: 5-point scale ranging from +2 
(very much satisfied) to í2 (very much dissatisfied) (day 71). Also done at 
day 360/end of study visit for observational assessments. 
All cellulite assessments will be done by treated quadrant. For initial treatment subjects who 
have 2 quadrants treated, each quadrant will be evaluated separately. 
17.5.1. 
Primary Efficacy Analysis 
The primary cellulite severity endpoint is the proportion of composite responders at day 71 
defined as subjects with an improvement in severity from baseline (Screening B visit) of at least 
2 levels of severity in the CR-PCSS and an improvement in severity from baseline of at least 2 
levels of severity in the PR PCSS. 
The primary endpoint, the proportion of composite responders with improvement of 2 or better 
on each scale (CR-PCSS and PR-PCSS) will be summarized by region treated (buttock or thigh) 
and overall with percentages. 
17.5.2. 
Secondary Efficacy Analysis 
Secondary endpoints for treated quadrants include: 
x Proportion of composite responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the CR-PCSS and an 
improvement of severity from baseline of at least 1 level of severity in the PR-PCSS. 
(day 71) 
x Proportion at each level of improvement in the PR-PCSS (day 71): 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels of severity in the PR-PCSS 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the PR-PCSS 
x Proportion at each level of improvement in the CR-PCSS (day 71): 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels of severity in the CR-PCSS (Investigator 
rated) 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the CR-PCSS (Investigator 
rated) 

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x Proportion of responders at each level of the I-GAIS (day 71): 
 Proportion of Investigator global responders defined as subjects with a response 
of 1 (improved) or better in the Investigator GAIS assessment 
x Proportion of responders at each level of the S-GAIS (day 71): 
 Proportion of subject global responders defined as subjects with a response of 
1 (improved) or better in the subject GAIS assessment 
x Proportion of responders at each level of the subject satisfaction with cellulite 
treatment (day 71) 
x Change in the Hexsel CSS total score from screening visit to day 71 
x All secondary endpoints, except the Hexsel CSS total score, will be summarized by 
treated region (buttock or thigh) and overall using percentages. Change in Hexsel 
CSS total score will be summarized by treated region (buttock or thigh) and overall 
with descriptive statistics for continuous variables. 
Observational endpoints include: 
x Proportion of 2-point composite responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point composite responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 2-point CR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point CR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 2-point PR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point PR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 

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x Duration of response as defined by the time from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant treated in study EN3835-201 until the time 
that the treated quadrant returned to the baseline PR-PCSS and CR-PCSS ratings 
from study EN3835-201. 
x CR-PCSS change from the study EN3835-201 baseline at day 71 of study 
EN3835-201, and days 90, 180, 270, and 360/end of study of the current study 
(EN3835-202). 
x PR-PCSS change from the study EN3835-201 baseline at day 71 of study 
EN3835-201, and days 90, 180, 270, and 360/end of study of the current study 
(EN3835-202). 
x Hexsel CSS total score changed from the study EN3835-201 baseline at day 71 of 
study EN3835-201 and day 360/end of study of the current study (EN3835-202).  
x Proportion of responses at each level of the I-GAIS (day 360/end of study): 
 Proportion of Investigator global responders defined as subjects with a response 
of 1 (improved) or better in the Investigator GAIS assessment 
 Change in I-GAIS assessment from day 71 of study EN3835-201 and day 360/ 
end of study of the current study (EN3835-202 
x Proportion of responses at each level of the S-GAIS (day 360/end of study): 
 Proportion of subject global responders defined as subjects with a response of 
1 (improved) or better in the subject GAIS assessment 
 Change in S-GAIS assessment from day 71 of study EN3835-201 and day 360/ 
end of study of the current study (EN3835-202) 
x Proportion of responses at each level of the subject satisfaction with cellulite 
treatment (day 360/end of study) 
 Change in subject satisfaction assessment from day 71 of study EN3835-201 and 
day 360/end of study of the current study (EN3835-202) 
For quadrants treated in the current study the following observational endpoints will be analyzed: 
x Proportion of 2-point composite responders as defined by the responses in the 
quadrant treated in this current study (EN3835-202) who either maintained response, 
lost response but did not return to the study EN3835-202 baseline, or returned to the 
study EN3835-202 baseline. 
x Proportion of 1-point composite responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 2-point CR-PCSS responders as defined by the responses in the 
quadrant treated in this current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 

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x Proportion of 1-point CR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 2-point PR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 1-point PR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x CR-PCSS change from the study EN3835-202 baseline at day 71, day 90, day 180, 
day 270, and day 360/end of study. 
x PR-PCSS change from the study EN3835-202 baseline at day 71, day 90, day 180, 
day 270, and day 360/end of study. 
x Duration of response as defined by the time from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant treated in the current study until the time that 
the treated quadrant returned to the baseline PR-PCSS and CR-PCSS ratings from 
study EN3835-202. 
17.6. 
Safety Analyses 
The following variables are safety endpoints. 
x AEs: Mapped to preferred term using the Medical Dictionary for Regulatory 
Activities (MedDRA) 
x Injection site reactions/local tolerability in selected quadrant (through subject and 
Investigator reporting) 
x Vital signs 
x Laboratory testing 
AEs will be summarized by treatment group. AE duration will be summarized using descriptive 
statistics by treatment group. 
Descriptive statistics will be presented for each clinical laboratory test for the actual and change 
from screening at each visit by treatment group and vital signs for the actual and change from 
day 1 pre-injection for each injection day at each visit by treatment group. 
17.6.1. 
Prior, Concomitant, and Follow-up Medication 
The World Health Organization (WHO) Drug Dictionary will be used to classify prior and 
concomitant medications by therapeutic class. The version used in this study will be stated in the 
Data Management Plan. Prior medication will be defined as any medication with a start date 
prior to the day 1 date and are collected at the screening visit and upon admission to the clinic on 

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day í1. Concomitant medication is defined as any medication with a start date on or after the 
day 1 date or reported as ongoing. Any medications started after the last dose of study drug will 
be considered as follow-up medications 
Prior and concomitant medication use will be summarized descriptively by the number and 
percentage of subjects receiving each medication within each therapeutic class. Multiple use of 
the same medication by a subject will be counted only once. 
17.6.2. 
Study Drug Exposure 
For those subjects that elect, are eligible, and do receive treatment, the number of injections will 
be summarized by counts and percentages. The number of dimples treated will be summarized 
with counts and percentages.  
17.6.3. 
Measurement of Treatment Compliance 
All doses are administered while the subjects are at the investigators’ sites. Any dose that was 
not administered per protocol will recorded as a protocol deviation by the Investigator. 
17.6.4. 
Adverse Events 
The MedDRA will be used to code AEs. The version used in this study will be stated in the Data 
Management Plan. 
An AE (classified by preferred term) that started during the treatment period will be considered a 
TEAE if it was not present prior to the first dose of study drug, or was present prior to the first 
dose of study drug but increased in intensity during the treatment period. If more than 1 AE is 
reported prior to the first dose of study drug and coded to the same preferred term, then the AE 
with the greatest intensity will be used as the benchmark for comparison to the AEs occurring 
during the treatment period which were also coded to that preferred term. Any AE present prior 
to the first dose of study drug that increases in intensity during the treatment period will be 
re-entered with a new start date of the date of increased intensity.  
Descriptive statistics (the number and percentage) for subjects reporting TEAEs in each 
treatment group will be tabulated by system organ class and preferred term; by system organ 
class, preferred term, and severity; and by system organ class, preferred term, and relationship to 
study drug. If more than 1 AE is coded to the same preferred term for the same subject, the 
subject will be counted only once for that preferred term using the most severe and most related 
occurrence for the summarization by severity and by relationship to the study drug. 
SAEs and AEs leading to premature discontinuation of study drug will be summarized by 
preferred term and dose received. Listings will be presented for subjects with SAEs, subjects 
with AEs leading to discontinuation, and subjects who die (if any). 
17.6.5. 
Vital Signs 
Descriptive statistics for vital signs (eg, systolic and diastolic blood pressure, pulse rate, and 
body weight) and their changes from baseline at each visit and at the end of treatment visit will 
be presented.  
Vital sign values are potentially clinically significant (PCS) if they meet both the observed value 
criteria and the change from baseline criteria. The criteria for PCS vital sign values will be 

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detailed in the Statistical Analysis Plan (SAP). A listing of all AEs for subjects with PCS vital 
signs will also be provided. 
17.6.6. 
Clinical Laboratory Parameters 
Descriptive statistics for clinical laboratory values in International System of Units (SI units) and 
changes from baseline will be presented for each clinical laboratory parameter. 
The number and percentage of subjects with PCS post-baseline clinical laboratory values will be 
tabulated. The criteria for PCS laboratory values will be detailed in the SAP. A listing of all AEs 
for subjects with PCS laboratory values will also be provided. 
17.7. 
Immunogenicity Analyses 
Immunogenicity variables include anti-AUX-I/anti-AUX-II binding antibody results. Binding 
antibody levels will be determined from samples collected on days 1, 22, 43, and 71 during the 
treatment phase and days 90, 180, 270 and 360 during the observational phase. 
Descriptive statistics (percent of positive measurements and average antibody level) will be 
presented for anti-AUX-I and anti-AUX-II antibody levels at each time point by region treated 
and overall. Average antibody levels will be summarized on logarithmically transposed titer 
values. 
17.8. 
Pharmacokinetic Analyses 
Not applicable. 
17.9. 
Interim Analysis 
Two (2) interim analyses are planned. Following the breaking of the study drug blind in study 
EN3835-201, all follow-up safety data gathered prior to that time will be analyzed. The second 
interim analyses will occur following the day 71 visit for all subjects treated with EN3835 in the 
current study. A preliminary data lock will be done on all treated quadrants and cellulite 
assessment and safety analyses will be done. The official database lock will occur after the last 
day 360/end of study observational visit and all observational analyses on treated quadrants will 
be done. 
17.10. 
Statistical Software 
Statistical analyses will be performed using Version 9.3 (or higher) of SAS® (SAS Institute, 
Cary, North Carolina). 

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accountability during monitoring visits. When instructed by Endo, the Investigator agrees to 
return all original containers of unused study drug to Endo or its designee. 
18.5.1. 
Study Drug Handling and Disposal 
The Investigator is responsible for recording the receipt and use of all drug supplied and for 
ensuring the supervision of the storage and allocation of these supplies. All unused study drug 
will be returned, and unit counts will be performed whenever medication is returned. The site 
must account for all study drug received. The Investigator agrees not to supply study drug to any 
person except to those subjects enrolled in the study. At the end of the study, all unused drug 
supplies will be returned to Endo as instructed by the clinical monitor. 

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19. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
19.1. 
Source Documents 
Source documents include but are not limited to original documents, data and records such as 
hospital/ medical records (including electronic health records), clinic charts, lab results, subject 
diaries, data recorded in automated instruments, microfilm or magnetic media, and pharmacy 
records, etc. At a minimum, all data required to be collected by the protocol should have 
supporting source documentation for entries in the eCRF, unless the protocol specifies that data 
can be recorded directly on/in the eCRF or other device. 
19.2. 
Study Monitoring 
A representative of Endo Pharmaceuticals Inc. will meet with the Investigator and his/her staff 
prior to the entrance of the first subject to review study procedures and methods of recording 
findings in the eCRF.  
After enrollment of the first subject, an Endo Pharmaceuticals Inc. representative will be 
assigned to periodically monitor each Investigator site for study progress and to verify that 
standards of Good Clinical Practice (GCP) were followed. The Investigator is expected to 
prepare for the monitor visit, ensuring that all source documents, completed eCRFs, signed 
consent forms, and other study related documents are readily available for review. 
19.3. 
Audits and Inspections 
The Investigator shall permit audits and inspections by the Sponsor, its representatives and 
members of regulatory agencies. The investigator should immediately notify the Sponsor of an 
upcoming FDA or other regulatory agency inspection. 
19.4. 
Institutional Review Board (IRB) 
The Investigator shall permit members of the IRB/IEC to have direct access to source 
documents. 
19.5. 
Data Recording and Documentation 
All data recordings and source documentation (including electronic health records) must be made 
available to the Sponsor (or designee), FDA and any other regulatory agencies that request 
access to study records, including source documents, for inspection and copying, in keeping with 
federal and local regulations. 

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20. 
QUALITY CONTROL AND QUALITY ASSURANCE 
Steps to assure the accuracy and reliability of data include the selection of qualified principal 
investigators and appropriate study centers, review of protocol procedures with the principal 
investigators and associated personnel prior to start of the study, and periodic monitoring visits 
conducted by the Sponsor or Sponsor representative. Significant and/or repeated non-compliance 
will be investigated and remedial action instituted when appropriate. Failure to comply with 
remedial actions may result in investigator site termination and regulatory authority notification. 
The Sponsor or its designee will utilize qualified monitors to review and evaluate activities 
conducted at Investigator Sites. 
The data will be entered into the clinical study database and verified for accuracy, following 
procedures defined by the Sponsor (or designee). Data will be processed and analyzed following 
procedures defined by the Sponsor (or designee). 
The study will be monitored and/or audited at intervals to ensure that the clinical study is 
conducted and data are generated, documented (recorded), and reported in compliance with the 
Study Protocol; International Conference on Harmonisation (ICH), E6 consolidated guidelines; 
and other applicable regulations. The extent, nature, and frequency of monitoring and/or audits 
will be based on such considerations as the study objectives and/or endpoints, the purpose of the 
study, study design complexity, and enrollment rate. At the conclusion of a program, a 
compliance statement will be generated by the Sponsor (or designee) listing all audit activities 
performed during the clinical study. 

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21. 
ETHICS 
21.1. 
Ethics Review 
Approval by the IRB/IEC prior to the start of the study will be the responsibility of the 
Investigator. A copy of approval documentation will be supplied to Endo Pharmaceuticals Inc. 
along with a roster of IRB members that demonstrates appropriate composition (a Department of 
Health and Human Services [DHHS] Assurance Number will satisfy this requirement).  
The study protocol, the informed consent form, advertisements, materials being provided to 
subjects and amendments (if any) will be approved to IRB/IECs at each study center in 
conformance with ICH E6, the Code of Federal Regulations (CFR), Title 21, Part 56 and any 
other applicable local laws. The Investigator is responsible for supplying the IRB/IEC with a 
copy of the current IB, Package Insert, or SPC as well as any updates issued during the study. 
During the course of the study, the Investigator will provide timely and accurate reports to the 
IRB/IEC on the progress of the study, at intervals not exceeding 1 year (or as appropriate), and 
will notify the IRB/IEC of SAEs or other significant safety findings, per the policy of the 
IRB/IEC. At the conclusion of the study, the Investigator will submit a final report or close out 
report to the IRB/IEC and provide a copy to Endo Pharmaceuticals Inc. 
Any amendment to this protocol will be provided to the Investigator in writing by Endo 
Pharmaceuticals Inc. No protocol amendment may be implemented (with the exceptions noted 
below) before it has been approved by the IRB and the signature page, signed by the 
Investigator, has been received by Endo Pharmaceuticals Inc. Where the protocol is amended to 
eliminate or reduce the risk to the subject, the amendment may be implemented before IRB 
review and approval. However, the IRB must be informed in writing of such an amendment and 
approval obtained within reasonable time limits. Deviating from the protocol is permitted only if 
absolutely necessary for the safety or clinical management of the subject, and must be 
immediately reported to Endo Pharmaceuticals Inc.  
The Investigator will be responsible for supplying updated safety and/or study information to 
study subjects as it becomes available. 
21.2. 
Ethical Conduct of the Study 
This clinical study is designed to comply with the ICH Guidance on General Considerations for 
Clinical Trials (62 FR 6611, December 17, 1997), Nonclinical Safety Studies for the Conduct of 
Human Clinical Trials for Pharmaceuticals (62 FR 62922, November 25, 1997), Good Clinical 
Practice: Consolidated Guidance (62 FR 25692, May 9, 1997) and 21 CFR parts 50, 54, 56, and 
312. 
The study will be conducted in full compliance with ICH E6, the FDA guidelines for GCP and in 
accordance with the ethical principles that have their origins in the Declaration of Helsinki 
defined in 21 CFR, 312.120. 

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21.3. 
Subject Information and Consent 
Subjects, after having the study explained to them and an opportunity to have their questions 
answered sufficiently, will give voluntary and written informed consent (in compliance with ICH 
E6, 4.8 and 21 CFR Parts 50 and 312) before participating in any study-related procedures. The 
consent shall be written in a language understandable to the subject. Subjects unable to read 
(illiterate) shall have the consent process performed in the presence of an independent witness 
who shall also sign the consent. Each subject will read, assent understanding, and sign an 
instrument of informed consent after having had an opportunity to discuss the study and consent 
documents with the Investigator before signing, and will be made aware that she may withdraw 
from the study at any time.  
In addition to obtaining informed consent, the Investigator is responsible for obtaining any 
additional documentation to demonstrate compliance with local privacy laws applicable to 
activities performed.  
The consent process shall be recorded in source documents. Signed copies of the informed 
consent will be given to the Subject and originals will be placed in the Investigator study files.  
A unique Subject identification number will be assigned according to section 12.1.3 at the time 
that the Subject signs the informed consent form. 
 

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22. 
DATA HANDLING AND RECORDINGKEEPING 
22.1. 
Data Collection 
Data collection will involve the use of an EDC system to which only authorized personnel will 
have access. The system will be secured to prevent unauthorized access to the data or the system. 
This will include the requirement for a user ID and password to enter or change data. The level 
of access to the EDC system will be dependent on the person’s role in the study. 
Study data will be collected from source documents and entered into an eCRF within the EDC 
system. The Investigator will be responsible for ensuring the eCRFs are completed in a timely 
manner relative to the subject’s visit. In addition to periodic monitoring occurring within the 
system by a Sponsor monitor, programmatic edit checks will be used to review EDC data for 
completeness, logic, and adherence to the study protocol. As a result of this monitoring and these 
checks, queries may be issued electronically to the clinical study sites and closed electronically 
by the monitor, data management staff or authorized staff at the study site. Additionally, the 
Investigator will review eCRFs, ensure all missing or corrected data is provided and will sign the 
eCRF pages with an electronic signature.  
An electronic audit trail will be maintained in the EDC system to track all changes made to data 
entered in the eCRF. Data will be retrievable in such a fashion that all information regarding 
each individual subject is attributable to that subject. Unless otherwise indicated, all data 
captured in the eCRF must first be captured in source documents. Data that can be directly 
recorded in the eCRF will be clearly identified in the section(s) of the protocol that describes the 
assessment(s). 
In addition, any contact with the subject via telephone or other means that provide significant 
clinical information must be documented in source documents as described above. 
22.2. 
Study Documentation 
Upon study completion, the Investigator will be provided with complete electronic copies of the 
CRF data for his/her files.  
 

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23. 
REPORTING AND PUBLICATION 
All data generated in this study are the property of Endo. An integrated clinical and statistical 
report will be prepared at the completion of the study. 
Publication of the results by the Investigator will be subject to mutual agreement between the 
Investigator and Endo. 

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24. 
INVESTIGATOR OBLIGATIONS 
24.1. 
Regulatory Documents 
The Investigator is responsible for creating and/or maintaining all study documentation required 
by 21CFR 50, 54, 56 and 312, ICH, E6 section 8, as well as any other documentation defined in 
the protocol or the Investigator Agreement. The Investigator must maintain the documentation 
relating to this study and permit Endo Pharmaceuticals Inc. or a member of a regulatory agency 
access to such records. 
The Investigator must provide the following key documents to Endo Pharmaceuticals Inc. prior 
to the start of the study: 
x A completed and signed Form FDA1572. If during the course of the study any 
information reported on the Form FDA 1572 changes, a revised Form FDA1572 must 
be completed and returned to Endo Pharmaceuticals Inc. for submission to the FDA. 
For studies executed outside the United States, documentation required by the 
governing regulatory authority may be substituted for the Form FDA 1572. 
x A fully executed contract 
x The Investigator’s Statement page in this protocol signed and dated by the 
Investigator and any subsequent amendment signature pages 
x The IB acknowledgment of receipt page 
x Curricula vitae for the Principal Investigator and all Sub-Investigators listed on Form 
FDA 1572, including a copy of each physician’s license (if applicable) 
x A copy of the original IRB/IEC approval for conducting the study. If the study is 
ongoing, renewals must be submitted at yearly intervals or shorter intervals defined 
by the IRB/IEC. All subsequent modifications must be submitted and approved by the 
IRB, as described in section 21.1  
x A copy of the IRB/IEC-approved informed consent form 
x A list of IRB/IEC members or DHHS Assurance Number 
x Laboratory certifications and normal ranges (if local labs are required by the protocol) 
x A financial disclosure agreement completed and signed by the Investigator and all 
Sub-Investigators listed on Form FDA 1572. Investigator site staff that submitted an 
initial financial disclosure are also responsible for informing Endo Pharmaceuticals 
Inc. of any changes to their initial financial disclosure form 1 year after the 
completion of the study. 
A complete list of required regulatory documents will be supplied by Endo Pharmaceuticals Inc. 
or its representative. 

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24.2. 
Delegation of Responsibilities and Adequate Resources 
The Investigator should have adequate time to conduct the study properly and should have an 
adequate number of qualified staff to assist with the conduct of the study. The Investigator shall 
delegate tasks only to individuals qualified by education, training and experience to perform the 
delegated tasks. The Investigator shall have direct oversight of all delegated activities and shall 
document delegation of responsibilities. The Investigator is responsible for ensuring all delegated 
staff have been properly trained on the protocol and their assigned study responsibilities. 
24.3. 
Medical Care of Study Subjects 
The Investigator and/or a qualified sub-investigator shall be responsible for the subjects’ medical 
care. Any unrelated medical condition discovered during the course of the study should be 
communicated to the subject so that they may seek appropriate medical care. The Investigator 
will report all AEs as required by the protocol (section 14.5). The Investigator will inform study 
subjects of new information regarding the study drug as it becomes available. 
24.4. 
Use of Investigational Materials 
The Investigator will acknowledge that the study drug supplies are investigational and as such 
must be used strictly in accordance with the protocol and only under the supervision of the 
Principal Investigator or Sub-Investigators listed on Form FDA1572 (or other regulatory 
document, depending on region). Study drug must be stored in a safe and secure location. At 
study initiation, a representative from Endo Pharmaceuticals Inc. will inventory the study drug at 
the site. The Investigator must maintain adequate records documenting the receipt and 
disposition of all study supplies. Endo Pharmaceuticals Inc. or its representative will supply 
forms to document total inventory as well as subject specific accountability. The Investigator is 
responsible for monitoring subject’s use of the study drug to ensure compliance with the 
protocol. All study supplies shall be returned to Endo Pharmaceuticals Inc. or its designee (this 
may include empty packaging such as bottles and blister cards). It is the Investigator’s 
responsibility to ensure that subjects return their medication. 
24.5. 
Retention of Records 
Federal and local regulations require that the Investigator retain a copy of all regulatory 
documents and records that support the data for this study (eg, informed consents, laboratory 
reports, source documents, study drug dispensing records) for whichever of the following is the 
longest period of time: 
x A period of 2 years following the final date of approval by the FDA or other 
regulatory agency of the study drug for the purposes that were the subject of the 
investigation; or 
x A period of 5 years following the date on which the results of the investigation were 
submitted to the FDA or other regulatory agency in support of, or as part of, an 
application for a research or marketing permit for the study drug for the purposes that 
were the subject of the investigation 
Endo will notify Investigators once one of the above 2 timeframes has been satisfied. 

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If the investigation does not result in the submission of the data in support of, or as part of, an 
application for a research or marketing permit, records must be retained for a period of 2 years 
following notification by Endo Pharmaceuticals Inc. that the entire clinical investigation (not 
merely the Investigator’s portion) is completed, terminated, or discontinued or 2 years following 
withdrawal of the Investigational New Drug application (IND).  
If the Investigator retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the study records, custody must be transferred to a person who will accept the 
responsibility. Endo must be notified in writing of the name and address of the new custodian. 
Study records should not be destroyed without consultation with Endo Pharmaceuticals Inc. 
24.6. 
Subject Confidentiality 
All subject records submitted to Endo Pharmaceuticals Inc. or its designee will be identified only 
by initials and code number. Subjects’ names are not to be transmitted to Endo Pharmaceuticals 
Inc. The Investigator will keep a Master Subject List on which the identification number and the 
full name, address, and telephone number of each subject are listed. It is the Investigators’ 
responsibility to inform study subjects that representatives of the Sponsor, FDA, or other 
regulatory agencies may review all records that support their participation in the study. The 
Investigator will adhere to all privacy laws to which she is subject. 
 

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25. 
TERMINATION OF STUDY 
The Sponsor has the right to suspend or terminate the study at any time. The study may be 
suspended or terminated for any reason. 

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26. 
INVESTIGATOR’S AGREEMENT 
I agree to conduct the study in accordance with the protocol, and with all applicable government 
regulations and Good Clinical Practice guidance. 
 
 
 
 
_____/_____/______ 
Investigator’s Signature 
Date 
 
 
 
Typed Name of Investigator 
 

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27. 
REFERENCES 
1. Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part I. Pathophysiology. 
J Am Acad Dermatol 2010;62(3):361-370. 
2. Hexsel D, de Oliveira Dal’Forno T, Mazzuco R. Definition, clinical aspects, 
classifications, and diagnostic techniques. In: Goldman MP, Hexsel D, eds. Cellulite: 
Pathophysiology and Treatment. 2nd ed. New York, NY: Informa Healthcare; 
2010:13-21. 
3. Rawlings AV. Cellulite and its treatment. Int J Cosmetic Sci. 2006;28(3):175-190. 
4. Terranova F, Berardesca E, Maibach H. Cellulite: nature and aetiopathogenesis. Int J 
Cosmetic Sci. 2006;28(3):157-167. 
5. Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther. 
2004;6(4):181-185. 
6. Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part II. Advances and 
controversies. J Am Acad Dermatol 2010;62(3):373-384. 
7. Collis N, Elliot LA, Sharpe C, Sharpe DT. Cellulite treatment: a myth or reality: a 
prospective randomized, controlled trial of two therapies, endermologie and 
aminophylline cream. Plast Reconstr Surg. 1999;104(4):1110-1114. 
8. Hexsel DM, Mazzuco R. Subcision: a treatment for cellulite. Int J Dermatol. 
2000;39(7):539-544. 
9. Boyce S, Pabby A, Chuchaltkaren P, Brazzini B, Goldman MP. Clinical evaluation of a 
device for the treatment of cellulite: Triactive. Am J Cosmet Surg. 2005;22:233-237. 
10. DiBernardo BE. Treatment of celllulite using a 1440-nm pulsed laser with one-year 
follow-up. Aesthet Surg J. 2011;31(3):328-341. 
11. Dagum AB, Badalamente MA. Collagenase injection in the treatment of cellulite. Plas 
Reconst Surg. 2006;118(suppl 4):53. 
12. Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity scale. 
J Eur Acad Dermatol Venereol. 2009;23(5):523-528. 
13. Nürnberger F, Müller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 
1978;4(3):221-229. 
 

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LIST OF APPENDICES 
Appendix A  Documents Required Prior to Initiation of the Study 
Appendix B  Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity 
scale. J Eur Acad Dermatol Venereol. 2009;23(5):523-528. 
Appendix C  Reference Images for Hexsel Severity Ratings 
Appendix D 
Patient’s Instructions for Use of the PR-PCSS 

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APPENDIX A. DOCUMENTS REQUIRED PRIOR TO INITIATION OF 
THE STUDY 
As a Sponsor of a clinical study, Endo Pharmaceuticals Inc. has an obligation to ensure that the 
study will be conducted by a qualified Investigator with sufficient resources of time, personnel, 
and physical facilities to conduct the study and to ensure that the Investigator understands and 
agrees to comply with the protocol, applicable regulations, policies, and procedures. The 
following documentation is required: 
From the Principal Investigator 
1. A signed agreement to perform the study per protocol (the signature page will suffice). 
2. A signed Letter of Financial Agreement (including confidentiality statement). 
3. Name(s) of the Principal Investigator and of all sub-Investigator(s) 
4. All address(es) of the clinical site(s). 
5. A current medical license valid where he/she practices and a current curriculum vitae for 
the Principal Investigator (signed and dated) and all sub-investigators, to contain at least 
the following elements: 
a. For physicians: 
i. Date of degree in Medicine 
ii. Name of the Institution granting the degree in Medicine. 
iii. Previous clinical postings with dates. 
b. For non-physician allowed by national law or regulations to act as clinical 
Investigators: 
i. Date and description of most advanced degree. 
ii. Name of the Institution granting the degree in number (i). 
iii. Other accreditation or qualifications relevant to the study. 
iv. Previous postings with dates. 
v. Name and qualification (see 5a above) of the physician or dentist in charge of 
study subjects. 
Note: If a non-physician is serving as Principal Investigator, then a qualified physician 
must be assigned as a sub-Investigator for the trial, to be responsible for all trial-related 
medical decisions. 
6. Written notification of Institutional Review Board/Independent Ethics Committee/Human 
Research Ethics Committee (IRB/IEC/HREC) approval. The minimum requirements are 
as follows: 
a. Dated letter, including: 
i. The date on which the meeting for the review of the study protocol took place. 
ii. Study protocol/amendment number, and version date 

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iii. A clear statement of approval of the protocol and the informed consent text with 
version date, and authorization for the study to proceed. 
iv. If the Investigator or any sub-Investigator is a part of the IRB/IEC/HREC 
Review Board, assurance that the Investigator abstained from voting at the 
meeting(s) when the study was discussed.  
b. A dated list of the members and their occupations. 
c. A specimen copy of the Committee-approved informed consent text to be used in the 
study. 
7. Food and Drug Administration (FDA) Form 1572 (for studies submitted under a US 
Investigational New Drug application [IND]). 
8. Financial Disclosure Certification or Certification of Non-Disclosure (for studies to be 
submitted for a US New Drug Application/Biologics License Application [NDA/BLA]). 
Other 
Any other documentation required by national law or regulations to be in the possession of the 
Sponsor or the Investigator for study participation or study initiation. 
 

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APPENDIX B. HEXSEL DM, DAL’FORNO T, HEXSEL CL. A 
VALIDATED PHOTONUMERIC CELLULITE SEVERITY 
SCALE. J EUR ACAD DERMATOL VENEREOL. 
2009;23(5):523-528. 
 

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APPENDIX D. PATIENT INSTRUCTIONS FOR USE OF PATIENT-
REPORTED PHOTONUMERIC CELLULITE SEVERITY 
SCALE (PR-PCSS) 
 

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2. 
SUMMARY OF CHANGES 
Not applicable 

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3. 
SPONSOR CONTACT INFORMATION 
Table 1: 
Sponsor Contact Information 
Role in Study 
Name 
Telephone and Email Address 
Clinical Research Scientist  
 
 
 
Clinical Trial Manager 
 
 
 
Medical Monitor 
 
TKL Research Inc 
 
 
 
SAE Reporting Pathway 
Not Applicable 
 
 
A list of other key study personnel and vendors will be provided upon request separately for your 
reference. 

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4. 
SYNOPSIS 
Name of Sponsor/Company: Endo Pharmaceuticals Inc.  
Name of Investigational Product: EN3835 
Name of Active Ingredient: Collagenase clostridium histolyticum 
Title of Study: A Phase 2, Open-Label Extension Study of EN3835 in the Treatment of Edematous 
Fibrosclerotic Panniculopathy 
Lead Principal Investigator: To be determined 
Study period:  
Estimated date first subject enrolled: Jun-2016 
Estimated date last subject completed: May-2017 
Phase of development: Phase 2 
Objectives:  
Primary: 
x 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at 
scheduled intervals over 1 year (12 months) in all subjects with edematous fibrosclerotic 
panniculopathy (EFP) who elect to enroll in this open-label trial regardless of their decision to 
receive treatment (re-treatment or re-dosing) of open-label EN3835 or opt to receive no 
treatment.  
Secondary: 
x 
To evaluate the durability of response to EN3835 in EFP severity over the 12-month post initial 
dosing of EN3835 in subjects previously receiving active treatment in study EN3835-201 using 
the Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS), the Clinician-Reported 
Photonumeric Cellulite Severity Scale (CR-PCSS), and the Hexsel Cellulite Severity Scale 
(CSS) 
x 
To evaluate long-term response to EN3835 in assessments of EFP including subject satisfaction, 
Investigator Global Aesthetic Improvement Scale (I-GAIS), and Subject Global Aesthetic 
Improvement Scale (S-GAIS) 
x 
To evaluate immunogenicity after exposure to EN3835 
Study Design: This study is a Phase 2 open-label study for the safety and efficacy of EN3835 in the 
treatment of EFP. To be eligible, a subject must have participated and completed the previous cellulite 
study EN3835-201. Subjects will be screened for study eligibility within 14 days prior to enrolling in 
this study (EN3835-202). Subjects will be assessed for safety and cellulite severity assessments 
approximately every 3 months for a maximum of 1 year from their first exposure to EN3835. Subjects 
with at least 1 quadrant with moderate or severe level of cellulite will be eligible for treatment with 
EN3835 after unblinding of study EN3835-201; a quadrant that was treated with EN3835 in the previous 
study EN3835-201 will only be eligible for retreatment if the cellulite severity in that quadrant is rated at 
levels of cellulite severity at baseline in study EN3835-201. 
A treatment course will consist of 3 treatment sessions separated by 21 days. Treatment will be allowed 
in eligible subjects up to a maximum of 2 treatment courses including the treatment course in study 
EN3835-201 if subject was treated with EN3835. Each treatment session will consist of up to 
12 injections (0.07 mg/0.3 mL per injection) of EN3835 for a dose of 0.84 mg and volume of 3.6 mL. 
Only a quadrant with moderate (rating of 3) or severe (rating 4) level of severity as assessed by the 
subject and investigator using the PR-PCSS and the CR-PCSS, respectively, will be eligible for 

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treatment; if more than 1 eligible quadrant exists, the quadrant selected will be at the discretion of the 
subject. Treatments will be administered on days 1, 22, and 43; subjects will be assessed for safety on 
days 1, 22, 43, and 71 and for cellulite severity assessments on days 1, 43, and 71. After day 71, they 
will be observed every 3 months from their first exposure to EN3835 up to a maximum of 1 year. The 
study will terminate when at least 100 subjects have been assessed at 12 months after the first exposure 
to EN3835. 
Number of subjects (planned): 333 
Study center(s): 16 sites in the United States  
Diagnosis and inclusion/exclusion criteria: 
Qualification for the Open-Label Observation Phase of the Study 
Inclusion criteria for observation:  
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be willing to apply sunscreen to any treated quadrant before each exposure to the sun while 
participating in the study (ie, screening through end of study) 
Exclusion criteria for observation: 
None 
Qualification for the Open-Label Treatment Phase of the Study 
Inclusion criteria for treatment: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 and all day 71 
assessments 
3. %HDIHPDOHyears of age 
4. At Screening B visit, have at least 1 quadrant with: 
a. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 
b. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and 
c. a Hexsel CSS score no greater than 13 
5. Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun 
while participating in the study (ie, Screening B through end of study) 
6. Be judged to be in good health, based upon the results of a medical history, physical 
examination, and laboratory profile at Screening B 
7. Have a negative urine pregnancy test at Screening B and before injection of study drug and be 
using an effective contraception method (eg, abstinence, intrauterine device [IUD], hormonal 
[estrogen/progestin] contraceptives, or double barrier method) for at least 1 menstrual cycle 
prior to study enrollment and for the duration of the study; or be menopausal defined as 
12 months of amenorrhea in the absence of other biological or physiological causes, as 
determined by the Investigator; or post-menopausal for at least 1 year; or be surgically sterile 
8. Be willing and able to cooperate with the requirements of the study 
9. Be able to read, complete and understand the patient-reported outcomes rating instruments in 
English 

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Exclusion criteria for treatment: 
1. Has used any of the following for the treatment of EFP on the legs or buttock within the 
timelines identified below or intends to use any of the following at any time during the course of 
the study: 
x 
Liposuction on the side of the body selected for treatment during the 12-month period 
before injection of study drug 
x 
Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or surgery 
(including subcision and/or powered subcision) within the selected treatment quadrant 
during the 12-month period before injection of study drug 
x 
Endermologie or similar treatments within the selected treatment quadrant during the 
6-month period before injection of study drug 
x 
Massage therapy within the selected treatment quadrant during the 3-month period before 
injection of study drug 
x 
Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected 
treatment quadrant during the 2-week period before injection of study drug 
2. Is presently nursing a baby or providing breast milk for a baby 
3. Intends to become pregnant during the study 
4. Has received an investigational drug or treatment within 30 days before injection of study drug 
5. Has a known systemic allergy to collagenase or any other excipient of study drug 
6. Is currently receiving or plans to receive anticoagulant or antiplatelet medication or has received 
DQWLFRDJXODQWRUDQWLSODWHOHWPHGLFDWLRQH[FHSWIRUPJDVSLULQGDLO\ZLWKLQGD\VEHIRUH
injection of study drug 
7. Has a known recent history of stroke, bleeding, or other medical condition, which in the 
investigator’s opinion would make the subject unsuitable for enrollment in this phase of the 
study 
8. Presence of any clinically relevant conditions, that in the opinion of the Investigator would 
interfere with completing the study including, but not limited to, visual problems, hearing 
problems, cognitive impairment or acute mental illness 
Investigational product, dosage and mode of administration: EN3835, 0.84 mg, subcutaneous. A 
dose of 0.84 mg of EN3835 will be administered as up to 12 subcutaneous injections (0.3-mL injection 
administered as three 0.1-mL aliquots per injection, up to 12 injections per treatment session) for a 
maximum volume of 3.6 mL per treatment session. A treatment course will consist of 3 treatment 
sessions at 21 days intervals, ie, treatments on days 1, 22, and 43 of each treatment course. 
For the observational periods of this study, subjects will be assessed for safety and cellulite severity 
assessments at approximately 3-month intervals for a maximum of 1 year following their first exposure 
to EN3835. 
Duration of study: Twelve (12) months from first exposure to EN3835 in study EN3835-201 or study 
EN3835-202 
Screening Phase: Up to 14 days 
Observational Phase: Subjects will be assessed at visits that occur approximately every 3 months for a 
maximum of 1 year after the first exposure to EN3835. 
Follow-up: Subjects will be assessed at visits that occur approximately every 3 months for a maximum 
of 1 year after the first exposure to EN3835. For subjects treated with EN3835 in this study, subjects 
will be observed at treatment visits (days 1, 22, and 43) and day 71 after first injection. 

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Reference therapy, dosage and mode of administration: Not applicable 
Criteria for evaluation: 
Efficacy: 
x 
PR-PCSS while viewing digital images of the selected quadrant: 5-point scale ranging from 
0 (no cellulite) to 4 (severe cellulite) (approximately every 3 months after initial injection [either 
an injection in previous study EN3835-201 or after an injection in this study]). If treatment is 
administered in this study, PR-PCSS will be obtained at Screening B (Baseline), days 22, 43, 
and 71 after initial treatment within this study. 
x 
Investigator using the CR-PCSS by live assessment: 5-point scale ranging from 0 (no cellulite) 
to 4 (severe cellulite) (every 3 months after initial injection [either an injection in previous study 
EN3835-201 or after an injection in this study]). If treatment is administered in this study, 
CR-PCSS will be obtained at Screening B (Baseline), days 22, 43, and 71 after initial treatment 
within this study. 
x 
Investigator rating of cellulite severity using the total score from the Hexsel CSS: scores can 
range from 0 (no cellulite) to 15 (extremely severe cellulite) (day 360). If treatment is 
administered in this study, Hexsel CSS will be obtained in this study at Screening B (Baseline) 
and day 71 after initial treatment within this study. 
x 
I-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) (day 71) 
x 
S-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) (day 71) 
x 
Subject satisfaction with cellulite treatment assessment: 5-point scale ranging from 2 (very 
satisfied) to í2 (very dissatisfied) (day 71) 
Safety:  
Safety will be assessed throughout the study through the recording of: 
x 
Adverse events (AEs) 
x 
Vital signs 
x 
Clinical laboratory tests 
x 
Immunogenicity assessment (ie, assessed through the determination of binding and neutralizing 
anti-AUX-I and anti-AUX-II antibody levels). 
In addition, for subjects treated with EN3835 in this study, injection site reactions/local tolerability in 
treated quadrant (through subject and Investigator reporting) will be assessed. 
Statistical methods: 
Sample Size Consideration:  
The number of subjects (approximately 333) is intended to obtain additional subjects for adequate long-
term safety data at the selected dose. 
Analysis Populations:  
Observational population: The Observational population is defined as all subjects treated with EN3835 
in study EN3835-201 who do not receive any treatment in the current study 
Safety population: The Safety population is defined as all enrolled subjects who received at least 1 
injection of EN3835 in this study or in study EN38335-201. 
Intent-to-Treat (ITT) population: The ITT population is defined as all enrolled subjects in this study. 

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Modified Intent-to-Treat (mITT) population: The mITT population is defined as ITT subjects who 
received at least 1 injection of EN3835 in this study with a baseline and 1 post-injection evaluation of 
both the CR-PCSS and PR-PCSS. All efficacy (cellulite assessments) analyses will be completed on this 
population. 
Per-Protocol population: The Per-Protocol population is defined as those subjects in the Safety 
population who have no major protocol deviations.  
Efficacy Evaluations: 
The primary cellulite severity assessment endpoint, the proportion of composite responders with 
improvement of 2 or better on each scale (CR-PCSS and PR-PCSS) at day 71, will be summarized as 
percentages and analyzed using a Cochran-Mantel-Haenszel test that compares the 2 treatment groups 
and adjusts for Investigator. The ITT population will be evaluated for the primary endpoint with any 
subjects not having a post-injection evaluation of either CR-PCSS or PR-PCSS classified as a 
non-responder. 
All secondary endpoints, except the Hexsel CSS total score, will be summarized as percentages. The 
dichotomous secondary endpoints (ie, responders endpoints) will be analyzed using a Cochran-Mantel-
Haenszel test adjusted for investigator. Multiple-response endpoints (ie, scales) will be analyzed using 
the Mann-Whitney test. Change in Hexsel CSS total score will be summarized with descriptive statistics 
for continuous variable and will be analyzed using analysis of variance (ANOVA). 
Safety Analysis:  
The following variables are safety endpoints: 
x 
AEs: Mapped to preferred term using the Medical Dictionary for Regulatory Activities 
(MedDRA) 
x 
Vital signs 
x 
Clinical laboratory tests 
AEs will be summarized by proportion of subjects reporting each event. Descriptive statistics will be 
presented for actual and change from baseline at each visit for vital signs and for each clinical laboratory 
test parameter. 
Immunogenicity: Anti-AUX-I and anti-AUX-II antibody levels will be summarized using descriptive 
statistics for the actual value at the visit. 
 

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5. 
SCHEDULE OF EVENTS 
NOTE: Observation visits (Table 2) in the open-label extension study begin after completion of 
double-blind study (day 71). Treatment sessions (Table 3), if elected, will begin when study drug 
blind is broken in study EN3835-201while observation visits continue concurrently. 
 

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a Eligible subjects may choose additional treatment any time after the study drug blind is broken in study EN3835-201. 
b Upon completion of treatment, subject will be followed at 3-month intervals as in Table 2; if study terminates early, subject will be followed through Visit 4 
(day 71). If subject received placebo in the double-blind study (EN3835-201), she may be eligible for a total of 2 courses of treatment (a total of 6 treatment 
sessions) in this study. 
c All 4 quadrants are photographed at screening; at other visits, the selected quadrant only is photographed. 
d Before and after marking the dimples. 
e Before injection. 
f Up to 4 hours before injection; approximately 15 and 30 minutes after injection. Vital signs must be stable before the subject is discharged. 
g Assessment made via photograph (if treatment session, use photograph taken before marking dimples). 
h All 4 quadrants are assessed at the Screening B visit; at other visits, the selected quadrant only is assessed. 
i Initial Hexsel CSS at sFUHHQLQJPXVWEHRQselected quadrant (Appendix C). 
j To qualify for treatment, the selected quadrant must have a score of 3 or 4 (moderate or severe) in both the CR-PCSS and PR-PCSS, and a Hexsel CSS score 
; to qualify a quadrant that had been previously treated with EN3835 in study EN3835-201, the quadrant must have CR-PCSS and PR-PCSS scores equal to 
or greater than study EN38325-EDVHOLQHVFRUHVDQGD+H[VHO&66VFRUH13. 
k Medical history and prior medications will be based on EN3835-201 eCRF; only updates and concomitant medications need to be captured at Screening B visit. 
l Do not conduct if Screening B visit date is within 12 months of obtaining an ECG during the double-blind study (EN3835-201). 
ECG=Electrocardiogram; eCRF=Electronic case report form; EFP=Edematous fibrosclerotic panniculopathy; Tx=Treatment 
NOTE: Subject cellulite assessments must be completed before the Investigator cellulite assessments are conducted at each visit. 
 

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6. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES 
TABLE OF CONTENTS 
1. 
TITLE PAGE ................................................................................................................1 
2. 
SUMMARY OF CHANGES ........................................................................................2 
3. 
SPONSOR CONTACT INFORMATION ...................................................................3 
4. 
SYNOPSIS ...................................................................................................................4 
5. 
SCHEDULE OF EVENTS ...........................................................................................9 
6. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES ...............13 
7. 
LIST OF ABBREVIATIONS.....................................................................................19 
8. 
INTRODUCTION ......................................................................................................21 
8.1. 
Edematous Fibrosclerotic Panniculopathy .................................................................21 
8.2. 
Current Edematous Fibrosclerotic Panniculopathy Treatments .................................21 
8.3. 
EN3835 (Collagenase Clostridium Histolyticum) ......................................................23 
8.3.1. 
Studies with EN3835 for the Treatment of Edematous Fibrosclerotic 
Panniculopathy ...........................................................................................................23 
8.3.1.1. 
Investigator-Initiated Proof-of-Concept Study ...........................................................23 
8.3.1.2. 
Endo-Sponsored Phase 1b Dose-Escalation Study AUX-CC-830 .............................24 
8.3.1.3. 
Endo-Sponsored Phase 2a Dose-Ranging Study AUX-CC-831 ................................24 
8.3.1.4. 
Endo-Sponsored Phase 2b Study EN3835-201 ..........................................................24 
8.4. 
Summary of Nonclinical Studies ................................................................................25 
8.5. 
Summary of Known Risks and Benefits .....................................................................25 
8.6. 
Rationale .....................................................................................................................25 
9. 
OBJECTIVES .............................................................................................................26 
9.1. 
Primary Objective .......................................................................................................26 
9.2. 
Secondary Objectives .................................................................................................26 
9.3. 
Exploratory Objectives ...............................................................................................26 
10. 
INVESTIGATIONAL PLAN .....................................................................................27 
10.1. 
Study Design ...............................................................................................................27 
10.2. 
Selection of Doses ......................................................................................................29 
10.3. 
Study Drug Administration.........................................................................................29 
10.4. 
Discussion of Study Design, Including the Choice of Control Groups ......................29 

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11. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................30 
11.1. 
Observation Phase ......................................................................................................30 
11.1.1. 
Subject Inclusion Criteria for Observation .................................................................30 
11.1.2. 
Subject Exclusion Criteria for Observation ................................................................30 
11.2. 
Treatment ....................................................................................................................30 
11.2.1. 
Subject Inclusion Criteria for Treatment ....................................................................30 
11.2.2. 
Subject Exclusion Criteria for Treatment ...................................................................31 
11.3. 
Subject Discontinuation Criteria .................................................................................32 
11.3.1. 
Replacement Procedures .............................................................................................32 
12. 
PROCEDURES AND TREATMENTS .....................................................................33 
12.1. 
Study Visits .................................................................................................................33 
12.1.1. 
Subject Screening .......................................................................................................33 
12.1.2. 
Screening Assessments ...............................................................................................33 
12.1.3. 
Study Entry/Observational Assessments ....................................................................33 
12.1.3.1. 
Three-Month Assessments..........................................................................................33 
12.1.4. 
Treatment Assessments (Optional) .............................................................................34 
12.1.4.1. 
6FUHHQLQJ%'D\VíWRí5HODWLYHWR2SHQ-Label Treatment Visit Day 1) .........35 
12.1.4.2. 
Treatment Session 1 (Visit 1B)...................................................................................36 
12.1.4.3. 
Treatment Session 2 (Visit 2/Day 22 ± 3 Days) and Treatment Session 3 
(Visit 3/Day 43 ± 3 Days) ...........................................................................................39 
12.1.4.4. 
Day 71 (±5 Days) End of Treatment/Early Termination ............................................40 
12.1.4.5. 
Follow-up Visits .........................................................................................................41 
12.2. 
Prior and Concomitant Medications and Procedures ..................................................41 
12.2.1. 
Prohibited Medications ...............................................................................................41 
12.2.2. 
Prohibited Procedures .................................................................................................41 
12.3. 
Treatment Compliance ................................................................................................41 
12.4. 
Blinding and Randomization ......................................................................................41 
12.5. 
End of Study ...............................................................................................................42 
13. 
ASSESSMENT OF EFFICACY ................................................................................43 
13.1. 
Primary Efficacy Measurements .................................................................................43 
13.1.1. 
Subject and Investigator Cellulite Assessments .........................................................43 
13.1.1.1. 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) ........................43 
13.1.1.2. 
Subject Global Aesthetic Improvement Scale (S-GAIS)............................................47 

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13.1.1.3. 
Subject Satisfaction with Cellulite Treatment Assessment ........................................47 
13.1.1.4. 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) ....................48 
13.1.1.5. 
Investigator Global Aesthetic Improvement Scale (I-GAIS) .....................................51 
13.1.1.6. 
Hexsel Cellulite Severity Scale ..................................................................................51 
14. 
ASSESSMENT OF SAFETY .....................................................................................53 
14.1. 
Definitions ..................................................................................................................53 
14.1.1. 
Adverse Event .............................................................................................................53 
14.1.2. 
Serious Adverse Event ................................................................................................53 
14.2. 
Monitoring Adverse Events ........................................................................................54 
14.3. 
Relationship to Study Drug ........................................................................................54 
14.4. 
Intensity Assessment ..................................................................................................55 
14.5. 
Reporting Adverse Events and Serious Adverse Events ............................................55 
14.5.1. 
Reporting Adverse Events ..........................................................................................55 
14.5.2. 
Reporting Serious Adverse Events .............................................................................55 
14.5.2.1. 
Follow-up Procedures for Serious Adverse Events ....................................................56 
14.6. 
Special Reporting Situations .......................................................................................56 
14.6.1. 
Adverse Events of Special Interest .............................................................................56 
14.6.2. 
Overdose/Misuse/Abuse .............................................................................................56 
14.6.3. 
Pregnancy ...................................................................................................................57 
14.6.4. 
Adverse Events/Serious Adverse Events Experienced by Non-subjects 
Exposed to Study Medication .....................................................................................57 
14.7. 
Clinical Laboratory and Immunogenicity Determinations .........................................57 
14.7.1. 
Anti-AUX-I and Anti-AUX-II Antibodies .................................................................58 
14.8. 
Vital Signs ..................................................................................................................59 
14.9. 
Electrocardiogram .......................................................................................................59 
14.10. 
Physical Examination .................................................................................................59 
14.11. 
Other Safety Assessments ...........................................................................................60 
15. 
ASSESSMENT OF PHARMACOKINETICS ...........................................................61 
16. 
ASSESSMENT OF PHARMACODYNAMICS ........................................................62 
17. 
STATISTICAL CONSIDERATIONS AND METHODS .........................................63 
17.1. 
Determination of Sample Size ....................................................................................63 
17.2. 
Subject Cohorts and Subject Populations ...................................................................63 
17.2.1. 
Observational Population ............................................................................................63 

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17.2.2. 
Safety Population ........................................................................................................63 
17.2.3. 
Intent-to-Treat Population ..........................................................................................64 
17.2.4. 
Modified Intent-to-Treat Population ...........................................................................64 
17.2.5. 
Per-Protocol Population ..............................................................................................64 
17.3. 
Subject Disposition .....................................................................................................64 
17.4. 
Demographics and Other Baseline Characteristics .....................................................64 
17.5. 
Efficacy Analyses .......................................................................................................64 
17.5.1. 
Primary Efficacy Analysis ..........................................................................................65 
17.5.2. 
Secondary Efficacy Analysis ......................................................................................65 
17.6. 
Safety Analyses ..........................................................................................................68 
17.6.1. 
Prior, Concomitant, and Follow-up Medication .........................................................68 
17.6.2. 
Study Drug Exposure ..................................................................................................69 
17.6.3. 
Measurement of Treatment Compliance ....................................................................69 
17.6.4. 
Adverse Events ...........................................................................................................69 
17.6.5. 
Vital Signs ..................................................................................................................69 
17.6.6. 
Clinical Laboratory Parameters ..................................................................................70 
17.7. 
Immunogenicity Analyses ..........................................................................................70 
17.8. 
Pharmacokinetic Analyses ..........................................................................................70 
17.9. 
Interim Analysis ..........................................................................................................70 
17.10. 
Statistical Software .....................................................................................................70 
18. 
STUDY DRUG MATERIALS AND MANAGEMENT ...........................................71 
18.1. 
Study Drug Identity ....................................................................................................71 
18.2. 
Study Drug Packaging and Labeling ..........................................................................71 
18.3. 
Study Drug Storage .....................................................................................................71 
18.4. 
Study Drug Preparation ..............................................................................................71 
18.5. 
Study Drug Accountability .........................................................................................71 
18.5.1. 
Study Drug Handling and Disposal ............................................................................72 
19. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS.........................................73 
19.1. 
Source Documents ......................................................................................................73 
19.2. 
Study Monitoring ........................................................................................................73 
19.3. 
Audits and Inspections ................................................................................................73 
19.4. 
Institutional Review Board (IRB) ...............................................................................73 
19.5. 
Data Recording and Documentation ...........................................................................73 

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20. 
QUALITY CONTROL AND QUALITY ASSURANCE .........................................74 
21. 
ETHICS ......................................................................................................................75 
21.1. 
Ethics Review .............................................................................................................75 
21.2. 
Ethical Conduct of the Study ......................................................................................75 
21.3. 
Subject Information and Consent ...............................................................................76 
22. 
DATA HANDLING AND RECORDINGKEEPING ................................................77 
22.1. 
Data Collection ...........................................................................................................77 
22.2. 
Study Documentation .................................................................................................77 
23. 
REPORTING AND PUBLICATION .........................................................................78 
24. 
INVESTIGATOR OBLIGATIONS ...........................................................................79 
24.1. 
Regulatory Documents ...............................................................................................79 
24.2. 
Delegation of Responsibilities and Adequate Resources ...........................................80 
24.3. 
Medical Care of Study Subjects .................................................................................80 
24.4. 
Use of Investigational Materials .................................................................................80 
24.5. 
Retention of Records ..................................................................................................80 
24.6. 
Subject Confidentiality ...............................................................................................81 
25. 
TERMINATION OF STUDY ....................................................................................82 
26. 
INVESTIGATOR’S AGREEMENT ..........................................................................83 
27. 
REFERENCES ...........................................................................................................84 
APPENDIX A. DOCUMENTS REQUIRED PRIOR TO INITIATION OF THE 
STUDY .......................................................................................................................86 
APPENDIX B. HEXSEL DM, DAL’FORNO T, HEXSEL CL. A VALIDATED 
PHOTONUMERIC CELLULITE SEVERITY SCALE. J EUR ACAD 
DERMATOL VENEREOL. 2009;23(5):523-528. .......................................................88 
APPENDIX C. REFERENCE IMAGES FOR HEXSEL SEVERITY RATINGS ....................96 
APPENDIX D. PATIENT INSTRUCTIONS FOR USE OF PATIENT-REPORTED 
PHOTONUMERIC CELLULITE SEVERITY SCALE (PR-PCSS) .........................97 
 

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LIST OF TABLES 
Table 1: 
Sponsor Contact Information ........................................................................................3 
Table 2: 
Observation Assessments ...........................................................................................10 
Table 3: 
Treatment Session Assessments .................................................................................11 
Table 4: 
Abbreviations and Specialist Terms ...........................................................................19 
Table 5: 
Concomitant Medication Restrictions for Subjects During the Treatment 
Phase of Study ............................................................................................................41 
Table 6: 
Subject Global Aesthetic Improvement Scale (S-GAIS)............................................47 
Table 7: 
Subject Satisfaction with Cellulite Treatment Assessment ........................................48 
Table 8: 
Investigator Global Aesthetic Improvement Scale (I-GAIS) .....................................51 
Table 9: 
Hexsel Cellulite Severity Scale ..................................................................................52 
Table 10: Clinical Laboratory Parameters ..................................................................................58 
Table 11: Vital Signs Measurements on Injection Day ..............................................................59 
 
LIST OF FIGURES 
Figure 1: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the 
Buttock ........................................................................................................................45 
Figure 2: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the 
Thigh ...........................................................................................................................46 
Figure 3: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for 
the Buttock ..................................................................................................................49 
Figure 4: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for 
the Thigh .....................................................................................................................50 
 
 

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7. 
LIST OF ABBREVIATIONS  
The following abbreviations and specialist terms are used in this study protocol. 
Table 4: 
Abbreviations and Specialist Terms 
Abbreviation 
Definition 
AE 
Adverse event 
Assigned quadrant 
Assigned quadrant (ie, left or right buttock, or the left or right posterolateral 
thigh) that was suitable for treatment and was randomly assigned in the double-
blind study (EN3835-201). To be suitable for treatment the quadrant must have 
an Investigator CR-PCSS and subject PR-PCSS score of 3 or 4 and a Hexsel 
CSS score of no greater than 13 at Screening B visit and at Day 1 visit. 
AUX-I 
Clostridial class I collagenase 
AUX-II 
Clostridial class II collagenase 
CFR 
Code of Federal Regulations 
CRF 
Case report form 
CR-PCSS 
Clinician-Reported Photonumeric Cellulite Severity Scale 
CSS 
Cellulite Severity Scale 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
EFP 
Edematous fibrosclerotic panniculopathy 
FDA 
Food and Drug Administration 
GCP 
Good clinical practice 
HREC 
Human research ethics committee 
IB 
Investigator Brochure 
ICF 
Informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent ethics committee 
I-GAIS 
Investigator-Global Aesthetic Improvement Scale 
IND 
Investigational new drug 
IRB 
Institutional review board 
ITT 
Intent-to-treat 
kDa 
Kilodalton 
MedDRA 
Medical Dictionary for Regulatory Activities 

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Table 4: 
Abbreviations and Specialist Terms (Continued) 
Abbreviation 
Definition 
mITT 
Modified intent-to-treat 
PCS 
Potentially clinically significant 
PR-PCSS 
Patient-Reported Photonumeric Cellulite Severity Scale 
Qualified designee 
Qualified by education and training to perform the study procedure (eg, 
sub-Investigator, nurse) 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
Selected quadrant 
Quadrant (ie, left or right buttock, or the left or right posterolateral thigh) that is 
suitable for treatment and is selected by patient and investigator for treatment. 
To be suitable for treatment the quadrant must have an Investigator CR-PCSS 
and subject PR-PCSS score of at least 3 or 4 and a Hexsel CSS score of no 
greater than 13 at Screening B visit. 
S-GAIS 
Subject – Global Aesthetic Improvement Scale 
TEAE 
Treatment-emergent adverse event; adverse events that occur on or after the 
first injection of study drug 
 

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8. 
INTRODUCTION 
8.1. 
Edematous Fibrosclerotic Panniculopathy 
Edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite, has been defined 
as a local metabolic disorder of subcutaneous tissues that results in an alteration of skin 
topography.(1) The condition manifests as dimpled skin, described as an orange-peel, cottage 
cheese, or mattress texture, particularly in the gluteal-femoral region.(2,3) EFP is caused by 
herniation of subcutaneous fat lobules through the dermohypodermal junction. This creates an 
uneven surface with dimpling.(1) EFP is a medical condition resulting in a potentially 
cosmetically unacceptable alteration of the skin, and affects an estimated 85% to 98% of 
postpubertal women.(1,3) 
The pathophysiology of EFP is not completely understood, but there are 3 main theories: edema 
resulting from excessive hydrophilia of the intercellular matrix, alteration of the regional 
microcirculation, and different anatomical conformation of collagenous subcutaneous tissues in 
women versus men.(4) 
It is known that EFP is different from generalized obesity. In generalized obesity, adipocytes 
undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs, and abdomen.(1) 
In areas of EFP, adipocytes have physiologic and biochemical properties that differ from adipose 
tissue located elsewhere. Large, metabolically-stable adipocytes characterize EFP-prone areas; 
thus, the responsiveness to catecholamine-induced lipolysis is less in EFP tissues compared to 
visceral fat, which has the greatest responsiveness.(1) 
Subcutaneous fat lobes are separated from one another by thin, usually rigid strands of 
collagenous connective tissues, which cross the fatty layers and connect the dermis to the 
underlying fascia. These septa stabilize the subcutis and divide the fat. In EFP, shortening of the 
collagen septa due to fibrosis provokes retraction at the insertion points of the trabeculae, 
causing the depressions that characterize EFP.(2) There are a higher percentage of thinner, 
perpendicular hypodermal septa in women with EFP than in men.(1) Weight gain makes EFP 
more noticeable, but it may be present even in thin subjects. Genetics may also play a role since 
EFP tends to run in families. 
8.2. 
Current Edematous Fibrosclerotic Panniculopathy Treatments 
There are therapies that have been utilized in an attempt to treat cellulite. Despite multiple 
therapeutic modalities, there is little scientific evidence that any of these treatments are 
beneficial. In fact, much of the evidence is anecdotal, subjective, or based only on patient self-
assessment.(5) Some of the historical treatments for EFP have included: 
x Weight loss: Weight loss generally decreases the severity of EFP but may only have a 
variable effect on EFP grades.(6) 
x Pharmacological agents (eg, xanthines, retinoids, lactic acid, and herbals): Although 
there are numerous topical treatments that are available over the counter, there are no 
well-designed or large-scale studies demonstrating the effectiveness of any of these 

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therapies.(5) Additionally, ingredients in some of the topical treatments are unknown 
and may pose an increased risk for adverse effects.(5) 
x Massage: Endermologie or lipomassage kneads the skin between rollers. This type of 
vigorous massage is posited to increase blood flow and reduce excess fluid in EFP 
prone areas. In a 12-week, randomized, controlled study of 52 women that examined 
the effectiveness of either endermologie or aminophylline versus a combination of 
both, there was no statistical difference in the thigh measurement between 
subjects.(7) 
x Liposuction: Liposuction can reshape the body, but it does not typically correct 
cellulite as it does not interrupt collagen septae in a directed fashion. Additionally, 
liposuction is not a recommended treatment for cellulite given the potential for poor 
cosmetic outcome.(5,6) 
x Mesotherapy: Mesotherapy involves injecting solutions containing various 
substances, eg, methylxanthines, to dissolve subcutaneous fat; however, this type of 
therapy often results in unwanted side effects, including infection, urticarial reactions, 
and bumpy or uneven skin contours.(6) To date, there are no regulatory approved 
mesotherapy mixtures for the treatment of EFP. 
x Radiofrequency: Radiofrequency systems may temporarily improve the appearance of 
EFP after a series of treatments; but long-term efficacy has not been demonstrated.(6) 
x Subcision: Subcision is an invasive surgical technique that severs the septa holding 
fat lobules that cause the skin dimpling associated with EFP. In a study conducted by 
Hexsel and Mazzuco, 232 subjects had subcision for the treatment of EFP.(8) 
Although 78% of subjects were satisfied after 1 treatment, there were no objective 
criteria by which to assess improvement, thereby limiting the value of this study. 
Additionally, side effects reported in this study included pain, bruising for 3 to 6 
months, hyperpigmentation for 2 to 10 months, and skin puckering.(5,6) These effects 
are most likely due to the trauma from shearing the septa with a large gauge needle 
(eg, 16 or 18 gauge) or other cutting devices. 
x Powered subcision: Powered subcision is a surgical technique utilizing a powered 
needle apparatus to sever the septa holding fat lobules that cause skin dimpling 
associated with EFP. The Cellfina® powered subcision device was recently approved 
by Food and Drug Administration (FDA; 2015) for the treatment of cellulite. 
x Laser: Intense pulsed light has been investigated for the treatment of cellulite. 
Triactive® is an FDA-approved low-fluorescence 810-nm light source combined with 
a 915-nm laser. In a study of 16 female subjects who underwent 12 treatments with 
the Triactive, 21% had improvement (based on 5 blinded Investigators’ analysis of 
photographs with respect to appearance of cellulite, skin tone, and texture) of their 
cellulite.(9) The CelluLaze™ system was used to treat cellulite on the thighs of 
10 healthy women.(10) In this Investigator-initiated study, subjects received a single 
treatment with a 1440-nm laser. During the CelluLaze procedure, which is performed 
under a local tumescent and general anesthetic, the physician inserts a small cannula 
through the skin and the device technology directs controlled, laser thermal energy to 

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the treatment zones. The laser is designed to diminish the lumpy pockets of fat by 
melting the hypodermal fat; release the areas of skin depression through thermal 
subcision of the septal tissue; and increase the elasticity and thickness of the skin by 
melting the fat in the dermal invaginations. Subjective physician and subject 
evaluations indicated improvement in the appearance of cellulite and high patient 
satisfaction that persisted for a year. For both the Triactive and CelluLaze studies, 
there were no control groups and significance was not tested.  
There remains an unmet medical need for safe and effective nonsurgical therapies to improve the 
esthetic outcome in women with cellulite. To effectively treat cellulite, a therapeutic approach 
may require disruption of the dermal septa, which are composed of collagen and cause the skin 
dimpling which is bothersome to many women. 
8.3. 
EN3835 (Collagenase Clostridium Histolyticum) 
Endo Pharmaceuticals Inc. (Endo) is developing EN3835 for the treatment of EFP. Because 
EN3835 is a proteinase that can hydrolyze the triple-helical region of collagen under 
physiological conditions, EN3835 has the potential to be effective in lysing subdermal collagen, 
such as those observed in the dermal septa, which are the underlying cause of the skin dimpling 
in women with EFP. EN3835 targets the collagenase structural matrix (eg, dermal septa) at the 
site of injection and does not require systemic exposure to be effective. 
EN3835 is a parenteral lyophilized product comprised of 2 collagenases in an approximate 1:1 
mass ratio, Collagenase I (AUX-I, Clostridial class I collagenase) and Collagenase II (AUX-II; 
Clostridial class II collagenase). These collagenases are isolated and purified from the 
fermentation of Clostridium histolyticum. Collagenase AUX-I is a single polypeptide chain 
containing approximately 1,000 amino acids of known sequence and with a molecular weight of 
114 kDa. Collagenase AUX-II is also approximately 1,000 amino acids long and has a molecular 
weight of 113 kDa. These 2 collagenases are not immunologically cross-reactive and have 
different specificities, such that together they become synergistic, providing a very broad 
hydrolyzing reactivity toward collagen. Clostridial collagenases are proteinases that can 
hydrolyze the triple-helical region of collagen under physiological conditions. 
EN3835 is currently approved for: 1) the treatment of adults with Dupuytren’s contracture with a 
palpable cord and, 2) for the treatment of adult men with Peyronie’s disease with a palpable 
plaque and curvature deformity of at least 30 degrees at the start of therapy. 
8.3.1. 
Studies with EN3835 for the Treatment of Edematous Fibrosclerotic 
Panniculopathy 
The studies summarized in this section are described in more detail in the Investigator’s 
Brochure (IB). 
8.3.1.1. 
Investigator-Initiated Proof-of-Concept Study 
In an Investigator-initiated pilot study, 10 female subjects received EN3835 in the treatment of 
cellulite.(11) A 10×10-cm oval area was outlined on the posterolateral thigh and 0.58 mg 
EN3835 was injected using a template as 5 concurrent subcutaneous injections of 0.116 mg per 
injection. Subjects were followed up to 180 days after injection for reduction of the cellulite 
appearance in the injected area. At 1 month post injection, the area of cellulite (as measured from 

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photographs) was reduced 89% from baseline. Patient satisfaction score was 1.75 at month 6 
(1=completely satisfied, 4=not satisfied). Side effects included the local events of injection area 
soreness, ecchymosis, and mild edema; these resolved within a mean of 18 days. The results 
from this study suggest that the collagen septa of EFP may be an appropriate substrate for lysis 
with injectable collagenase, and that treatment with collagenase appears to be tolerable and 
possibly effective. However, due to the paucity of the data, no conclusions could be drawn 
regarding dose, frequency, and injection technique. 
8.3.1.2. 
Endo-Sponsored Phase 1b Dose-Escalation Study AUX-CC-830 
A dose-ranging Phase 1b dose escalation study (AUX-CC-830) used a template arrangement of 
injections as was used in the Investigator-initiated pilot study but injected a matrix of doses, 
concentrations and injectate volumes to select doses for further development. This Phase 1b 
study showed efficacy results suggesting that collagenase clostridium histolyticum (CCH) may 
be effective in the treatment of EFP based on global aesthetic improvement at day 90 with 
ratings of “improved” by 43.4% of Investigators and 52.5% of subjects. The majority of subjects 
(71.7%) were “quite satisfied” or “very satisfied” with treatment on day 90. Adverse 
events(AEs) were local injection site events (bruising, pain, erythema, and edema) were mild or 
moderate and resolved within a period of 3 weeks. 
8.3.1.3. 
Endo-Sponsored Phase 2a Dose-Ranging Study AUX-CC-831 
The Phase 2a study (AUX-CC-831) was a double-blind, placebo-controlled, dose-ranging study 
of 150 women randomized to 0.06, 0.48, or 0.84 mg of CCH; or placebo in a 5:5:5:3 ratio. Each 
subject could receive up to 3 treatment sessions of study drug separated by approximately 
21 days. Efficacy in this study was evaluated based on Investigator Global Aesthetic 
Improvement Scale (GAIS-I) and Subject Global Aesthetic Improvement Scale (GAIS-S) along 
with other measures of treatment efficacy. Improvements were observed in cellulite appearance 
based on the statistically significant changes in the appearance of cellulite based on both the 
GAIS-I and GAIS-S scores for the high and mid doses compared to placebo (p<0.05). The 
majority of the patients were either satisfied or very satisfied with the results of their cellulite 
treatment with the mid and high doses compared to placebo (p<0.05). Similar to the AEs 
reported in subjects in the previous study (AUX-CC-830) and subjects who received EN3835 for 
Dupuytren’s contracture and Peyronie’s disease, the majority of AEs occurred at the site of 
injection and resolved before the next scheduled treatment session. 
8.3.1.4. 
Endo-Sponsored Phase 2b Study EN3835-201 
Currently there is an ongoing Phase 2b study (EN3835-201) which is a double-blind, placebo-
controlled study of 350 adult women randomized to EN3835 0.84 mg or placebo in a 1:1 ratio. 
Each subject can receive up to 3 treatment sessions of study drug separated by approximately 
21 days; last visit is day 71. Efficacy is being evaluated using a Clinician-Reported 
Photonumeric Cellulite Severity Scale (CR-PCSS), a Patient-Reported Photonumeric Cellulite 
Severity Scale (PR-PCSS), the Hexsel Cellulite Severity Scale (CSS), GAIS-I, GAIS-S, and a 
subject satisfaction assessment. Subjects that complete study EN3835-201 will be offered the 
option of participating in study EN3835-202. 

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8.4. 
Summary of Nonclinical Studies 
Nonclinical studies necessary to support clinical studies have been performed and are 
summarized in the IB. Nonclinical studies in the following areas were performed: toxicology, 
reprotoxicity, genotoxicity, and carcinogenicity.  
8.5. 
Summary of Known Risks and Benefits 
A summary of safety risks is provided in the IB. The following events have been commonly 
observed in prior studies: injection site AEs such as bruising, edema, erythema and pain. 
There are previously generated potential clinical benefits associated with EN3835 in treating 
EFP, however, such potential benefits need further clinical evaluation. It is hoped that data from 
this clinical study will demonstrate a measurable sustained or durable clinical benefit of EN3835 
in EFP as well as longer term safety.  
8.6. 
Rationale 
This study will allow an evaluation of longer term safety (over 12 months) following EN3835 
treatment of subjects with EFP. Additionally, although uncontrolled, an assessment of cellulite 
assessments (efficacy) of EN3835 in the treatment of quadrants with moderate or severe cellulite 
will be conducted in subjects treated with placebo or EN3835 in the previous double-blind study 
(EN3835-201). The safety of re-dosing either in a previously treated quadrant (termed 
re-treatment) or in a naive quadrant (termed re-dosing) in subjects that previously received 
EN3835 treatment in study EN3835-201 will be assessed. Finally, the durability of improvement 
will be evaluated in enrolled subjects following EN3835 treatment in the double-blind study 
(EN3835-201) as well as those being treated with EN3835 in this open-label study 
(EN3835-202). 
 

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9. 
OBJECTIVES 
9.1. 
Primary Objective 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at scheduled 
intervals over 1 year (12 months) in all subjects with EFP who elect to enroll in this open-label 
trial regardless of their decision to receive treatment (re-treatment or re-dosing) of open-label 
EN3835 or opt to receive no treatment.  
9.2. 
Secondary Objectives 
x To assess safety and immunogenicity of re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
x To evaluate the durability of response to EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects previously receiving active-treatment in 
study EN3835-201 using the PR-PCSS, the CR-PCSS, and the Hexsel CSS 
x To evaluate long-term response to EN3835 in assessments of EFP including subject 
satisfaction, I-GAIS, and S-GAIS 
x To assess cellulite severity assessments in quadrants treated in this study with 
EN3835 
9.3. 
Exploratory Objectives 
There are no exploratory objectives for this open-label extension study. 
 

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10. 
INVESTIGATIONAL PLAN 
10.1. 
Study Design 
This open-label extension study will be performed at multiple centers currently participating in 
the double-blind, placebo-controlled, parent trial (EN3835-201) in the United States. The open-
label extension study will enroll up to 350 subjects. The study is planned to end when at least 
100 subjects have 12 months after exposure ie 12 months after first treatment in study 
EN3835-201 or study EN3835-202. Subjects who completed the entire double-blind study and 
sign an informed consent will be eligible to enter this open-label extension.  
After the Sponsor has broken the EN3835-201 study drug blind, subjects enrolled in the open-
label study will have the following options: 
x To have no EN3835 treatments in study EN3835-202 
x If received EN3835 in study EN3835-201, may elect to have a qualifying quadrant 
other than the one treated in study EN3835-201 treated with EN3835 (termed 
re-dosing) 
x If received EN3835 in study EN3835-201 and the cellulite severity scores of the 
treated quadrant have returned to or are greater than EN3835-201 baseline scores, 
may elect to have the previously treated quadrant retreated with EN3835 (termed 
re-treatment) 
x If received placebo in study EN3835-201, may elect to have a qualifying quadrant 
treated with EN3835; also may elect to have a second qualifying quadrant treated 
with EN3835 after completing the treatment course  
Subjects enrolled in study EN3835-202 who elect to receive EN3835 treatment (either 
re-treatment, re-dosing, or a first treatment) must meet specific inclusion and exclusion criteria 
for eligibility during re-screening (Screening B) prior to EN3835 dosing.  
Following completion of safety and cellulite assessments at day 71 of the double-blind study 
(EN3835-201), subjects will be asked if they wish to continue in the open-label extension to the 
double-blind study (Screening A). At the time of entry into the open-label study, subjects and 
Investigators will remain blinded to study drug. Until the EN3835-201 study drug blind is broken 
by the Sponsor, subjects will undergo observation-only visits at 3-month intervals ± 7 days 
(relative to the initial dose in the double-blind study) where both safety and cellulite severity 
assessments of the treated quadrant will be made. 
Following the study drug blind being broken and communicated to centers, treatments of eligible 
subjects with EN3835 can begin at a visit at the discretion of the subject. Subjects electing not to 
receive further EN3835 treatments (observation-only subjects) will continue to be followed for 
safety and cellulite severity assessments at 3-month intervals through month 12. Up to 14 days 
prior to initiating treatment injections of EN3835 on open-label treatment visit day 1, subjects 
will undergo a screening evaluation (Screening B) to determine if they meet specified inclusion 
and exclusion criteria and to determine the quadrants, if any, that qualify for treatment.  

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During Screening B, photographs will be taken of each of the subject’s 4 quadrants (left 
buttocks, right buttocks, left posterolateral thigh, and right posterolateral thigh). Subjects will 
again receive instructions for use of the PR-PCSS and will subsequently use the scale to rate the 
severity of their cellulite in each of the 4 quadrants by comparing digital images of each of their 
quadrants displayed on standardized computer monitors with the PR-PCSS instrument. This 
independent self-assessment will take place in a private setting to minimize any potential bias 
from site personnel. The Investigator will then assess the subject’s 4 quadrants live in real-time 
using the CR-PCSS. The Investigator will rate the 4 quadrants using the Hexsel CSS as described 
in section 13.1.1.6.(12) Subjects must have at least 1 quadrant that meets the following criteria 
for inclusion into the treatment phase of the study: 
1. PR-PCSS score of 3 or 4, and 
2. CR-PCSS score of 3 or 4, and  
3. Hexsel CSS score of no greater than 13. 
After the independent assessments are completed separately by the subject and the Investigator, 
the Investigator will review his/her assessments and the subject’s assessment to determine which 
quadrants, if any, are eligible. The eligible quadrant chosen to receive treatment in the open-label 
study EN3835-202 will be at the discretion of the subject. A quadrant may be chosen for 
re-treatment if it was the quadrant treated in study EN3835-201 or a new quadrant may be 
chosen for re-dosing. NOTE: For subjects who received active drug in the assigned 
quadrant in the double-blind study, the quadrant must have cellulite severity at (or 
greater) than the EN3835-201 baseline scores of PR-PCSS and CR-PCSS to qualify for 
re-treatment. 
Previously placebo-treated subjects will have the option to receive a second course of EN3835 in 
the same or different qualifying quadrant after at least 28 days following end of the first 
treatment course (ie treatment of second quadrant could begin on day 71 after treating the first 
quadrant). The selected quadrant can be re-treated or re-dosed.  
At each treatment session visit, Investigators will select the dimples within the chosen quadrant 
to be treated. Selection of dimples to be treated in the quadrant will be at the discretion of the 
Investigator. The selected EFP dimples in the selected quadrant must be well-defined and evident 
when the subject is standing in a consistent relaxed pose (without the use of any manipulation 
such as skin pinching or muscle contraction). The dimples selected to be treated will be circled 
with a surgical marker and injection site locations should be marked with a dot; if more than 1 
injection per dimple is needed, the injection sites should be separated by approximately 2 cm. 
The selected quadrant will be photographed again after marking dimples. Subjects will be 
administered a maximum of EN3835 0.84 mg from a total of up to 12 injections. Up to 12 
injections will be administered at each treatment session to treat the selected quadrant. Each of 
the injections will be administered as three 0.1-mL aliquots (total injection volume per injection 
is 0.3 mL; total injection volume per treatment session is 3.6 mL [12 injections × 0.3 mL], see 
table below).  
Subjects will receive 3 treatment sessions (day 1, day 22, and day 43) unless the chosen quadrant 
has no further treatable EFP dimples and the Investigator rates the quadrant a score of 0 on the 
CR-PCSS. The same dimples within a quadrant or different dimples within a quadrant may be 

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treated at each session but injections must all be within the selected quadrant for all 3 sessions. 
Each treatment session will be separated by approximately 21 days. 
Dose per 
Each Injectiona 
Injection 
Volume per 
Each Injection 
Maximum 
Number of 
Injections per 
Each Treatment 
Session 
Maximum Dose 
(mg) per Each 
Treatment 
Session 
Maximum 
Injection Volume 
(mL) per Each 
Treatment 
Session 
Maximum 
Cumulative EFP 
Dose 
EN3835 0.07 mg 
N=333 
0.3 mL 
12 injections  
0.84 mg 
(12 injections  
× 0.07 mg) 
3.6 mL 
(12 injections  
× 0.3 mL) 
2.52 mg 
(3 treatment sessions 
× 0.84 mg) 
a Each injection of EN3835 is 0.3 mL administered as three 0.1-mL aliquots.  
The complete Schedule of Events is provided in section 5 (Table 2 and Table 3) and summarized 
in section 12. 
10.2. 
Selection of Doses 
Maximum possible doses of EN3835 employed will be the same as that administered in the 
double-blind, placebo-controlled, parent study (EN3835-201). 
10.3. 
Study Drug Administration 
Study drug in the form of sterile vials of lyophilized EN3835 (formerly AA4500) and sterile 
diluent will be provided by Endo. Study drug administration at each injection site is presented in 
section 12.1.4.2. 
10.4. 
Discussion of Study Design, Including the Choice of Control Groups 
The use of the open-label extension design allows for the following: 
x Safety data over a 12-month period will be collected to assist in further defining the 
safety profile of EN3835 in this population, 
x Safety data and immunogenicity after repeat exposure (re-treatment/re-dosing) and 
monitoring of previously active-treated subjects to EN3835 over a 12-month period,  
x Previously placebo-treated subjects to have exposure to EN3835, and  
x Durability of the response to EN3835 (cellulite severity assessments) will be 
assessed.  

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11. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
11.1. 
Observation Phase 
All subjects who have completed the double-blind study EN3835-201, including all day 71 
assessments, and sign informed consent are eligible for enrollment in this open-label extension 
study and participation in the ongoing safety and cellulite evaluations.  
11.1.1. 
Subject Inclusion Criteria for Observation 
To qualify for this open-label observation study a subject must: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be willing to apply sunscreen to any treated quadrant before each exposure to the sun 
while participating in the study (ie, screening through end of study) 
11.1.2. 
Subject Exclusion Criteria for Observation 
None 
11.2. 
Treatment 
Inclusion and exclusion criteria presented in section 11.2 apply only to those subjects in the 
open-label study who choose treatment. 
At the time that the study drug blind is broken in the double-blind study EN3835-201, qualified 
subjects enrolled in the open-label study are eligible for treatment. A subject may participate in 
the observational period of this open-label study regardless of scoring of quadrant; however to 
receive treatment in this study, a subject must have at least 1 qualifying quadrant. 
11.2.1. 
Subject Inclusion Criteria for Treatment 
To qualify for treatment in the study a subject must: 
1. Voluntarily sign and date an informed consent agreement 
2. Have participated in and completed the double-blind study EN3835-201 
3. Be a female 8 years of age 
4. At Screening B visit, have at least 1 quadrant with: 
a. a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and 
b. a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and 
c. a Hexsel CSS score no greater than 13 
5. Be willing to apply sunscreen to the selected treatment quadrant before each exposure to 
the sun while participating in the study (ie, Screening B through end of study) 
6. Be judged to be in good health, based upon the results of a medical history, physical 
examination, and laboratory profile at Screening B 

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7. Have a negative urine pregnancy test at Screening B and before injection of study drug 
and be using an effective contraception method (eg, abstinence, intrauterine device 
[IUD], hormonal [estrogen/progestin] contraceptives, or double barrier method) for at 
least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be 
menopausal defined as 12 months of amenorrhea in the absence of other biological or 
physiological causes, as determined by the Investigator; or post-menopausal for at least 
1 year; or be surgically sterile. 
8. Be willing and able to cooperate with the requirements of the study 
9. Be able to read, complete and understand the patient-reported outcomes rating 
instruments in English 
11.2.2. 
Subject Exclusion Criteria for Treatment 
A subject will be excluded from treatment in the study (but not from the observation 
assessments) if she: 
1. Has used any of the following for the treatment of EFP on the legs or buttock within the 
timelines identified below or intends to use any of the following at any time during the 
course of the study: 
x Liposuction on the side of the body selected for treatment during the 12-month period 
before injection of study drug 
x Injections (eg, mesotherapy); radiofrequency device treatments; laser treatment; or 
surgery (including subcision and/or powered subcision) within the selected treatment 
quadrant during the 12-month period before injection of study drug 
x Endermologie or similar treatments within the selected treatment quadrant during the 
6-month period before injection of study drug 
x Massage therapy within the selected treatment quadrant during the 3-month period 
before injection of study drug 
x Creams (eg, Celluvera™, TriLastin®) to prevent or mitigate EFP within the selected 
treatment quadrant during the 2-week period before injection of study drug 
2. Is presently nursing a baby or providing breast milk for a baby 
3. Intends to become pregnant during the study 
4. Has received an investigational drug or treatment within 30 days before injection of study 
drug 
5. Has a known systemic allergy to collagenase or any other excipient of study drug 
6. Is currently receiving or plans to receive anticoagulant or antiplatelet medication or has 
receiYHGDQWLFRDJXODQWRUDQWLSODWHOHWPHGLFDWLRQH[FHSWIRU mg aspirin daily) 
within 7 days before injection of study drug 
7. Has a known recent history of stroke, bleeding, or other medical condition, which in the 
investigator’s opinion would make the subject unsuitable for enrollment in this phase of 
the study 

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11.3. 
Subject Discontinuation Criteria 
A premature discontinuation will occur when a subject who signed informed consent ceases 
participation in the study, regardless of circumstances, prior to the completion of the protocol. 
Subjects can be prematurely discontinued from the study for one of the following reasons: 
x An adverse event (AE) 
x A protocol violation (reason must be specified, for example: lack of compliance, use 
of a prohibited concomitant medication, failure to meet inclusion/exclusion criteria 
after study entry, etc) 
x Withdrawal by subject (reason must be specified) 
x The subject was “lost to follow-up”  
x Other reasons (reason must be specified, for example: the subject moved, pregnancy, 
investigator decision, Sponsor decision to terminate trial, etc) 
If a subject discontinues from the study, all end-of-study procedures should be conducted as 
detailed in Schedule of Events. The date a subject discontinues, the treatment, and the reason for 
discontinuation will be recorded in the source documentation and Electronic Case Report Form 
(eCRF). If, however, a subject withdraws consent, no end-of-study procedures are required 
except the collection of AE information. This information should be recorded in the source 
documentation and the eCRF.  
11.3.1. 
Replacement Procedures 
Subjects who discontinue prematurely from the study will not be replaced. 

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12. 
PROCEDURES AND TREATMENTS 
12.1. 
Study Visits 
The Schedule of Events to be performed at each visit is shown in section 5. Provided below are 
further details where additional instruction about the assessments that will be performed is 
deemed to be needed. 
12.1.1. 
Subject Screening 
Upon completion of day 71 assessments in the double-blind study EN3835-201, a subject will be 
eligible to enter this open-label extension study. Investigators will be expected to maintain a 
Screening Log of all potential study subjects. This log will include limited information about the 
potential subject and the date and outcome of the screening process (eg, enrolled into the study, 
reason for ineligibility, or refused to participate). Investigators will provide information about the 
study to subjects who appear to meet the criteria for participation in the study. 
12.1.2. 
Screening Assessments 
After obtaining informed consent, the full assessment of eligibility will be conducted and prior to 
study entry, screening assessments will be performed. Details about how the informed consent 
will be obtained and documented are provided in section 21.3, Subject Information and Consent. 
The subject may be entered into the observational phase of the study and complete safety and 
cellulite severity assessments at 3-month intervals as detailed in Table 2. In addition, once the 
study blind is broken in study EN3835-201, enrolled subjects will be asked if they wish to 
receive additional open-label treatments. If a subject elects to receive open-label treatment, study 
assessments will be conducted in accordance with Table 3. 
12.1.3. 
Study Entry/Observational Assessments 
A subject who gives written informed consent and who satisfies all eligibility criteria 
(section 11) may be entered into the observational phase of the study and complete safety and 
cellulite severity assessments at 3-month intervals as detailed in Table 2. In addition, once the 
study drug blind is broken in study EN3835-201, enrolled subjects will be asked if they wish to 
receive additional open-label treatments. If a subject elects to receive open-label treatment, study 
assessments will be conducted in accordance with Table 3. The subject identification number 
will be carried over from the double-blind, placebo-controlled study (EN3835-201). 
12.1.3.1. Three-Month Assessments 
Subjects will return within 20 days (±4 days) of completion of the double-blind study for the first 
of 4 safety and cellulite severity evaluation visits. Assessments to be completed at these visits are 
detailed in Table 2. Subjects are to return at 3-month intervals until they have completed 
12 months from day 1 of the double-blind study. At these visits, quadrant(s) previously treated 
with EN3835 in the EN3835-201 study or quadrants treated with EN3835 in the open-label study 
will be evaluated. If the quadrant treated in study EN3835-201 is retreated in the open-label 
study, the 3-month assessments will reset to treatment visit 1/day 1 of the open-label treatment 
and the study visits will continue as described in Table 3 followed by 3-month assessments as 

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described in Table 2. If a different quadrant is treated in the open-label study, the 3-month 
assessments of both the quadrant treated in the double-blind study (EN3835-201) and the 
quadrant treated in the open-label study will continue. 
12.1.4. 
Treatment Assessments (Optional) 
At the time of unblinding of treatment assignment in the EN3835-201 study, subjects are eligible 
for optional treatment in the open-label study, provided they meet the inclusion and exclusion 
criteria detailed in section 11 and at least 1 quadrant meets the criteria for treatment. A subject 
may receive a maximum of 2 courses of treatment (6 treatment sessions) overall (total of 
treatments in double-blind and open-label study). If a subject received placebo in the double-
blind study, she may be eligible for 2 treatments in the open-label study; if a subject received 
active drug in the double-blind study, she may be eligible for 1 additional treatment (3 treatment 
sessions) in the open-label study.  
Selection of Treatment Quadrant 
During the Screening B visit, each subject will have photographs taken of the 4 targeted 
quadrants of the study (eg, their left and right buttocks and left and right posterolateral thighs). 
Subjects will receive instructions (Appendix D) for using the PR-PCSS and will use the scale to 
rate the severity of their cellulite in each of the 4 quadrants by comparing each of their digital 
image photographs with the PR-PCSS instrument. This self-assessment will take place in a 
private setting to minimize any potential bias from site personnel (the Investigator is blinded to 
these scores). The Investigator will then assess each of the 4 subject’s quadrants live in real-time 
using the CR-PCSS. The Investigator will then examine each of the 4 quadrants live to assess the 
subject using the Hexsel CSS as described in section 13.1.1.6.(12) Subjects must have at least 
1 quadrant that meets the following criteria for treatment in the study: 
1. PR-PCSS score of 3 or 4, and 
2. CR-PCSS score of 3 or 4, and  
3. Hexsel CSS score no greater than 13.  
After the independent assessments are completed separately by the subject and the Investigator, 
the Investigator will review his/her assessments and the subject’s assessment to determine which 
quadrants, if any, are eligible. The eligible quadrants (must meet all 3 of the inclusion criteria 
(PR-PCSS, CR-PCSS, and Hexsel CSS scores), if any, for treatment will be determined by the 
Investigator after which the quadrant selected will be at the discretion of the subject. For subjects 
treated with EN3835 in the double-blind study, if the quadrant treated in the double-blind study 
(EN3835-201) has PR-PCSS and CR-PCSS ratings identical or more severe than the double-
blind study (EN3835-201) PR-PCSS and CR-PCSS baseline ratings (Baseline is day 1 of study 
EN3835-201), subjects can elect to have that same quadrant re-treated. Subjects who choose 
re-treatment of the previously treated quadrant will be classified in the re-treatment arm. If 
another quadrant besides the previously treated quadrant meets the all 3 of the inclusion criteria, 
subjects can choose to be treated in the naive quadrant. Subjects who choose treatment into a 
naive quadrant will be classified in the re-dosing arm. 

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Assessments made with the PR-PCSS (from digital image), the CR-PCSS (live assessment), and 
the Hexsel CSS score during the open-label Screening B visit will be the baseline severity of 
EFP in the selected quadrant.  
A subject who received placebo in the double-blind study may be treated in the same quadrant in 
the open-label study if the quadrant still meets all 3 criteria OR another qualifying quadrant may 
be selected for treatment by the Investigator and subject. Following day 71 of a treatment course 
(3 treatment sessions), subjects can choose to receive a second treatment session in either the 
same quadrant if it still meets qualification criteria or in a different quadrant that meets 
qualification criteria. For the first treatment session, these subjects will be considered in the 
treatment arm. For the second treatment session, if the same quadrant is treated, subjects will be 
in the re-treatment arm; if a different quadrant is treated, subjects will be considered in the 
re-dosing arm.  
If no quadrant meets all 3 criteria, the subject may continue in the observation-only study with 
safety and cellulite severity evaluations performed at 3-month intervals but may not receive 
treatment in this study. 
Selecting and Marking Dimples 
Selection of dimples to be treated in the selected quadrant is at the discretion of the Investigator 
or qualified designee. Dimples must be well-defined and evident when the subject is standing in 
a consistent relaxed pose (without the use of any manipulation such as skin pinching or muscle 
contraction). Each subject will receive 3 treatment sessions of study drug in the selected 
quadrant. During each treatment session, the treatment quadrant will be photographed before and 
after dimple marking while the subject is standing in a consistent relaxed pose as described in the 
Photography Manual. The cellulite severity assessments using the PR-PCSS, CR-PCSS, and 
Hexsel CSS will be completed prior to dimple marking at treatment visits 2, 3, and 4/end of 
treatment. 
12.1.4.1. Screening B (Days í14 to í1 Relative to Open-Label Treatment Visit Day 1) 
Subjects meeting the relevant criteria listed in section 11.2 may be eligible for treatment in the 
open-label study. The following procedures will be performed and documented during the 
screening period: 
1. Evaluate eligibility based on inclusion/exclusion criteria (section 11.2) 
2. Subject will have digital photographs taken of the 4 targeted quadrants of the study (left 
and right buttocks, and left and right posterolateral thighs) (section 13.1) 
3. Subjects will get instruction on the use of the PR-PCSS (Appendix D) 
4. Subjects will rate each quadrant using the PR-PCSS while viewing their digital images 
(section 13.1.1.1) 
5. The Investigator will conduct live assessments of subject’s cellulite severity of each 
quadrant using the CR-PCSS (section 13.1.1.4) 
6. The Investigator will conduct live cellulite evaluation of each quadrant using the Hexsel 
CSS (section 13.1.1.6).  

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7. If at least 1 quadrant qualifies based on PR-PCSS, CR-PCSS, and Hexsel CSS ratings, 
subject may return for treatment on treatment visit 1. If none of the 4 quadrants qualify, 
the subject may remain in the study and have safety and cellulite severity evaluations 
performed at 3-month intervals but is not eligible for treatment. 
8. Subject will select an eligible quadrant (based on qualifying scores) to be treated at their 
discretion. 
9. Medical history including EFP history. Medical history will be based on EN3835-201 
eCRF; only updates to the history need to be captured at Screening B visit. 
10. Record prior and concomitant medications/procedures. Prior medications will be based 
on EN3835-201 eCRF; only updates and concomitant medications need to be captured at 
Screening B visit (section 12.2). 
11. Physical examination including measurement of body weight and height (section 14.10)  
12. Vital sign measurements (section 14.8) 
13. 12-lead electrocardiogram (ECG), not necessary if the date of the ECG obtained during 
the double-blind study (EN3835-201) is within 12 months of the date of the Screening B 
visit (section 14.9) 
14. Collection of samples for: 
a. Clinical laboratory testing including Anti-AUX-I and anti-AUX-II antibody testing 
(section 14.7) 
b. Urine pregnancy testing (section 14.7) 
15. Adverse events (section 14) 
12.1.4.2. Treatment Session 1 (Visit 1B)  
Pre-injection 
1. Confirm eligibility criteria (section 11) 
2. Take digital photography of selected quadrant before dimple marking (section 13.1) 
3. Record concomitant medications/procedures (section 12.2) 
4. Vital sign measurements (section 14.8)  
5. Collection of samples for urine pregnancy testing (section 14.7) 
6. Select and mark dimples to be treated (section 12.1.4) 
7. Take digital photograph of selected quadrant after dimple marking (section 13.1) 
Injection 
Administration of study drug in the prone position (see below) 
Post-injection 
1. Record number of dimples treated and number of injections administered 

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2. Vital sign measurements (section 14.8) 
3. Injection site reactions and local tolerability 
4. Adverse events (section 14) 
The selected quadrant will be photographed before and after dimple marking while the subject is 
standing in a consistent relaxed pose as described in the Photography Manual. Before injection at 
treatment session 1, the Investigator or qualified designee will begin the session by selecting 
dimples within the chosen quadrant that are well defined, evident when the subject is standing, 
and suitable for treatment; treatment consists of up to 12 injections per session.. Because the goal 
of treatment is to improve the aesthetic appearance of the entire quadrant, the Investigator will be 
instructed to select dimples that in his or her opinion would most improve the aesthetic 
appearance of the entire quadrant. The same dimples within a quadrant or different dimples 
within a quadrant may be treated at each session but injections must all be within the selected 
quadrant for all 3 sessions. 
For each dimple selected for treatment, the Investigator or qualified designee will choose 
injection sites (injection sites within a dimple should be spaced approximately 2 cm apart, if a 
dimple requires more than 1 injection). Each injection site will be marked with a “dot” using a 
surgical marker. For round dimples, the “dot” will be placed in the center of the dimple; for 
elongated dimples, “dots” will be spaced out approximately 2 cm along the longer axis of the 
dimple. The Investigator or qualified designee will then use a surgical marker to circle each of 
the dimples selected for treatment. Circles in the selected quadrant should not overlap.  
Examples of subject dimple marking: 
Sample Thigh Marking 
Sample Buttock Marking 
Study Drug Administration at Each Injection Site 
See section 18.4 for study drug preparation. Study drug will be injected subcutaneously while the 
subject is in a prone position using a syringe with a 30-gauge ½-inch needle. Each injection site 
will receive a single skin injection of study drug administered as three 0.1-mL aliquots to 
Positions A, B and C (for a total injection volume of 0.3 mL) as shown in the following figure. 

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Care Procedures After Injection 
To evaluate the subject for possible immediate immunological AEs, the subject will remain in 
direct observation of medical personnel who are skilled in the management of an allergic 
reaction for 30 minutes after receiving the injection of study drug and until the subject exhibits 
no sign of an immunological or other clinically significant systemic or local AE. The subject’s 
vital signs should be stable before the subject can leave direct observation (see section 14.8).  
The Investigator or qualified designee will then apply a sterile dressing to the injection site with 
hypoallergenic tape. The subject will be instructed to remove the dressing in the evening.  
12.1.4.3. Treatment Session 2 (Visit 2/Day 22 ± 3 Days) and Treatment Session 3 
(Visit 3/Day 43 ± 3 Days) 
Pre-injection 
1. Record concomitant medications/procedures (section 12.2) 
2. Body weight measurements  
3. Vital sign measurements (section 14.8)  
4. Collection of samples for urine pregnancy testing (section 14.7) 
5. Digital photograph of selected quadrant before dimple marking (section 13.1) 
6. Subject assessment of the severity of cellulite using photograph of the selected quadrant 
via PR-PCSS (section 13.1.1.1). NOTE: Complete the subject (PR-PCSS) assessment 
before the Investigator (CR-PCSS) assessment and before dimple marking. 
7. Investigator live assessment of the severity of cellulite using the CR-PCSS 
(section 13.1.1.4) 
8. Selection and marking of dimples to be treated (section 12.1.4)  
9. Digital photograph after dimple marking (section 13.1)  
Injection 
Administration of study drug in the prone position (section 12.1.4.2) 
Post-injection 
1. Record number of dimples treated and number of injections administered 
2. Vital sign measurements (section 14.8) 
3. Injection site reactions and local tolerability  
4. AEs (section 14) 
If no injections are given at treatment session 2, subjects will still return for the day 43 visit and 
the selected quadrant will again be evaluated by the subject (PR-PCSS) and Investigator 
(CR-PCSS). If the Investigator rates the selected quadrant greater than 0 on the CR-PCSS, 
injections at treatment session 3 should be given. 

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Because the goal of treatment is to improve the aesthetic appearance of the entire quadrant, the 
Investigator will be instructed to select dimples that in his or her opinion would most improve 
the aesthetic appearance of the entire quadrant. The same dimples within a quadrant or different 
dimples within a quadrant may be treated at each session but injections must all be within the 
selected quadrant for all 3 sessions. Each subject will receive all 3 treatment sessions unless the 
selected quadrant has no treatable EFP dimples and the Investigator rates the quadrant a score of 
0 on the CR-PCSS.  
After the dimples are selected, the Investigator or qualified designee will again mark each 
injection site with a “dot,” and circle each dimple (circles should not overlap).  
12.1.4.4. Day 71 (±5 Days) End of Treatment/Early Termination 
The following procedures will be performed on Day 71: 
1. Record concomitant medications/procedures (section 12.2) 
2. Measurement of body weight  
3. Vital sign measurements (section 14.8)  
4. Collection of samples for: 
a. Clinical laboratory testing (section 14.7) 
b. Anti-AUX-I and anti-AUX-II antibody testing (section 14.7.1)  
5. Digital photograph of selected quadrant (section 13.1)  
6. Subject cellulite assessments of the selected quadrant using the photographic image 
(NOTE: complete subject cellulite assessments before Investigator cellulite assessments) 
using: 
a. PR-PCSS assessment (section 13.1.1.1) 
b. S-GAIS (section 13.1.1.2) 
c. Subject satisfaction with cellulite treatment assessment (section 13.1.1.3) 
7. Investigator cellulite assessments of selected quadrant using: 
a. CR-PCSS live assessment of subject (section 13.1.1.4) 
b. Hexsel CSS assessment of live subject while subject is standing in a relaxed position 
(section 13.1.1.6) 
c. I-GAIS (section 13.1.1.5) 
8. Injection site reactions and local tolerability 
9. AEs (section 14) 

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12.1.4.5. Follow-up Visits 
Following the day 71 visit, the quadrant(s) treated with EN3835 in the open label study will be 
evaluated every 3 months from the first exposure to EN3835 following the schedule in Table 2. 
The first follow-up visit will be approximately20 days after the day 71 visit (ie approximately 
day 90 after treatment session 1). Follow-up visits will continue until the study is terminated 
when at least 100 subjects have been assessed at 12 months after the first exposure to EN3835. 
12.2. 
Prior and Concomitant Medications and Procedures 
All medications (including over-the-counter medications) taken by the subject at screening 
visit 1 through the end of the study must be recorded 
Additionally, any diagnostic, therapeutic or surgical procedures performed during the study 
period should be recorded including the date, indication for and description of the procedure.  
12.2.1. 
Prohibited Medications 
The following medications are prohibited for those subjects that elect to have treatment with 
study drug during the treatment phase of the study: anticoagulants (warfarin, heparin, direct 
thrombin inhibitors, Factor X inhibitors) and antiplatelet agents (aspirin >150 mg/day and P2Y12 
inhibitors, such as clopidogrel), which can cause additional bruising. However the use of aspirin 
DWDGRVHOHYHORIPJSHUGD\ZLOOEHSHUPLWWHGGXULQJWKHtreatment phase of the study. For 
those subjects in the observational-only phase of study, there are no prohibited medications: 
Table 5: 
Concomitant Medication Restrictions for Subjects During the Treatment 
Phase of Study 
Drug Class 
Restrictions 
Anticoagulants 
Subjects who elect treatment cannot take antiplatelet agents or 
DQWLFRDJXODQWVH[FHSWIRU mg aspirin daily) within 7 days before 
and after the dosing administration. 
12.2.2. 
Prohibited Procedures 
The treatments and procedures listed in exclusion criteria are prohibited during the study. 
12.3. 
Treatment Compliance  
All subjects who elect to have treatment will receive study drug administered by a clinician at the 
investigator’s site. 
Accidental or intentional overdoses should be reported to the Sponsor/designee promptly (see 
section 14.6.2). 
12.4. 
Blinding and Randomization 
This study will be conducted as an open-label investigation; no blinding of assigned treatment 
will occur. 

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12.5. 
End of Study 
The end of study is when 100 subjects complete the 1-year safety and cellulite severity 
evaluations. At the time of study termination, ongoing subjects receiving treatment will be 
followed through the day 71 visit. The remaining enrolled subjects (in excess of the first 
100 subjects to complete 1 year) will undergo early termination procedures in accord with the 
Schedule of Events (section 5) 
 

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13. 
ASSESSMENT OF EFFICACY 
13.1. 
Primary Efficacy Measurements 
Although measures of efficacious drug effect (ie, durability of improvement) will be made 
during the observation phase before the study drug blind is broken in the double-blind study 
(EN3835-201), and thereafter to the end of study, emphasis is on the assessment of safety over 
12 months after exposure to EN3835. Cellulite severity assessments will be made at scheduled 
intervals for both observation-only subjects (not receiving EN3835) as well as subjects who 
choose re-dosing or re-treatment with EN3835. 
Digital Photography: Digital photography will be utilized to assess certain cellulite severity 
parameters at specific intervals (see Schedule of Events, Table 2) for subjects in the observation-
only group as well as those electing to be re-treated or re-dosed with EN3835. At the 
Screening B visit for subjects electing to receive re-dosing or re-treatment, the Investigator or 
qualified designee will photograph each quadrant using a Sponsor-supplied standardized digital 
camera. The subject will be standing for each photography session and will be wearing a 
standardized photographic garment as described in the Photography Manual. The Investigator or 
qualified designee will photograph the selected quadrant as follows: 
x Screening B (no dimple marking)  
x Before and after dimple marking (prior to injections) on days 1, 22, and 43 of each 
treatment course 
x During the day 71 visit (end of treatment phase/early termination) of each treatment 
course 
All photographs from this study are the property of Endo and may be utilized for clinical 
development, scientific communication, marketing, regulatory purposes, and/or legal 
applications as required/desired by Endo. 
13.1.1. 
Subject and Investigator Cellulite Assessments 
As in the double-blind parent study, Investigator cellulite assessments are independent of the 
subject assessments. Therefore, all subject cellulite assessments must be completed before the 
Investigator’s cellulite assessments are made. After both the subject’s and investigator’s 
assessments are completed, the subject’s assessments will be revealed and compared to the 
clinician’s assessments to determine eligible quadrants. If more than 1 quadrant is eligible, the 
subject will select one for treatment. 
13.1.1.1. Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) 
The PR-PCSS will be conducted for the purpose of assessing the severity of cellulite in the 
buttock or thigh; there are separate scales for buttocks or thighs. The scales are 5-level 
photonumeric scales developed specifically for patients and used by the subject to assess the 
severity of their cellulite in the quadrants by viewing digital images of each of their quadrants 
captured by photography at the visit; the ratings range from 0 (None) to 4 (Severe) with labels 
and descriptors to aid the subject in the assessments.  

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All subjects who enter the observation-only phase of the study will have the PR-PCSS evaluation 
at months 3, 6, 9, and 12. 
For subjects electing re-treatment or re-dosing after the study drug blind is broken in study 
EN3835-201, a Screening B visit (Baseline) within 14 days before dosing day 1 will occur. 
Subjects will have digital photographs taken of all 4 quadrants as done in the double-blind trial 
for qualifying purposes. Subjects will then perform the PR-PCSS for both buttocks (Figure 1) 
and thighs (Figure 2) and will be reminded of their proper use (Appendix D).  
At the beginning of visits on days 22, 43, and 71; digital photographs of the selected quadrant 
will be taken. If the buttock is the treated region, subjects will be given the PR-PCSS for the 
buttock to use to make their evaluation; if the thigh is the treated region, subjects will be given 
the PR-PCSS for the thigh to make their evaluation.  
 

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Figure 1: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the Buttock 
 

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Figure 2: 
Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) for the Thigh 

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13.1.1.2. Subject Global Aesthetic Improvement Scale (S-GAIS) 
Subjects in the observation-only group will complete the S-GAIS as described below at the final 
study visit (month 12 or early termination) using the pre-treatment day 1 image (Baseline) of the 
assigned quadrant in the double-blind study for comparison. 
The S-GAIS assessment will be done on day 71 of the treatment course and then at month 12 or 
the final study visit and compared back to the pre-dosing Screening B image (Baseline for 
treatment subjects) of the selected quadrant. All treated subjects will be instructed to answer the 
following question: How would you rate the appearance of your treated cellulite after 
treatment? 
The S-GAIS assessment will occur after the subject has completed the PR-PCSS assessment to 
avoid introducing potential bias to the static PR-PCSS assessment. Each subject will view the 
pre-dosing Screening B visit digital image alongside their day 71 treatment course visit and 
month 12 or end of study visit digital image of their selected quadrant to aid in the assessment 
(Table 6). Subjects will circle the rating below that best represents their answer. 
Table 6: 
Subject Global Aesthetic Improvement Scale (S-GAIS) 
Rating 
Response Option 
Description 
+3 
Very much improved 
My treated cellulite looks very much better. 
+2 
Much improved 
My treated cellulite looks much better, but additional treatment 
would slightly improve the result. 
+1 
Improved 
My treated cellulite looks better, but additional treatment is 
necessary. 
0 
No change 
My treated cellulite looks essentially the same as it did 
originally. 
í1 
Worse 
My treated cellulite looks worse than it did originally. 
í2 
Much worse 
My treated cellulite looks much worse than it did originally. 
í3 
Very much worse 
My treated cellulite looks very much worse than it originally. 
13.1.1.3. Subject Satisfaction with Cellulite Treatment Assessment 
For observation-only subjects (not receiving EN3835) the subjects will assess their satisfaction 
with cellulite treatment at the 12 month or end of study visit by being instructed to answer the 
following question: Today, how satisfied are you with the results of the cellulite treatment you 
received on the specific area or areas on your buttocks or thighs that were treated? Subjects will 
circle the rating in the below table that best represents their answer. 
For subjects who have elected to receive EN3835 either through re-treatment or re-dosing, the 
subject satisfaction with the cellulite treatment (Table 7) with be done at the treatment course 
day 71 and the month 12 visit or end of study visit. Subjects will be instructed to answer the 
following question: Today, how satisfied are you with the results of the cellulite treatment you 
received on the specific area or areas on your buttocks or thighs that were treated? Subjects will 
circle the rating below that best represents their answer. 

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Table 7: 
Subject Satisfaction with Cellulite Treatment Assessment 
Rating 
Description 
+2
I am very satisfied with the cellulite treatment on my buttocks or thighs. 
+1
I am satisfied with the cellulite treatment on my buttocks or thighs. 
0 
I am neither dissatisfied nor satisfied with the cellulite treatment on my buttocks or thighs. 
í1
I am dissatisfied with the cellulite treatment on my buttocks or thighs. 
í2
I am very dissatisfied with the cellulite treatment on my buttocks or thighs. 
13.1.1.4. Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) 
The CR-PCSS will be conducted for the purpose of assessing the severity of cellulite in the 
buttock or thigh; there are separate scales for buttocks or thighs. The scales are 5-level 
photonumeric scales developed specifically for clinicians and used by the investigator to assess 
the severity of the subject’s cellulite in the quadrants by live assessments of the subject’s 
quadrant(s); the ratings range from 0 (None) to 4 (Severe) with labels and descriptors to aid the 
investigator in the assessments.  
Investigators will have been trained on the use of the CR-PCSS. For observation-only subjects, 
the CR-PCSS will be done at 3, 6, 9, and 12 months or at the end of study visit. 
For subjects who elected to receive EN3835 after the study drug blind is broken in study 
EN38325-201 as a re-treatment or re-dosing, the Investigator, at the Screening B visit (Baseline) 
will determine severity of cellulite of the 4 quadrants by assessing live subjects using the 
CR-PCSS for buttock (Figure 3) and thighs (Figure 4) after the subject has completed their self-
assessment using the PR-PCSS. The eligible quadrant chosen for injection will be at the 
discretion of the subject. Before injections on treatment visit days 22 and 43 and on visit day 71; 
Investigators will evaluate the selected quadrant by live assessments. If the buttock is the treated 
region, the Investigator will be use the CR-PCSS for the buttock to make their evaluation; if the 
thigh is the treated region, the Investigator will use the CR-PCSS for the thigh to make their 
evaluation. In each case, the Investigator will make his/her assessment independently and after 
the subject has conducted their self-assessment using the PR-PCSS. 

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Figure 3: 
Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) for the Buttock 
 

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13.1.1.5. Investigator Global Aesthetic Improvement Scale (I-GAIS) 
Subjects in the observation-only group will complete the I-GAIS as described below at the final 
study visit (month 12 or early termination) and a comparison back to the pre-treatment day 1 
(Baseline) image of the assigned quadrant of the double-blind study. 
On day 71 of the treatment course and the 12 month or end of study visit, the Investigator will 
determine the degree of improvement from the Screening B digital image of the selected 
quadrant by comparing the cellulite in live assessment on day 71 and at month 12 or study end to 
the Screening B pre-treatment (Baseline) image of the subject’s selected quadrant (Table 8). The 
I-GAIS assessment will occur after the CR-PCSS assessment (section 13.1.1.4) to avoid 
introducing potential bias to the static CR-PCSS assessment by the Investigator at the site. The 
Investigator will circle the rating below that best represents their answer. 
Table 8: 
Investigator Global Aesthetic Improvement Scale (I-GAIS) 
Rating 
Response Option 
Description 
+3 
Very much improved 
Optimal cosmetic result from treatment of the treated dimples 
+2 
Much improved 
Marked improvement in the treated area appearance from 
before treatment, but not completely optimal 
+1 
Improved 
Obvious improvement in the treated area appearance from 
before treatment, but additional treatment is indicated 
0 
No change 
The treated area appearance is essentially the same as before 
treatment 
í1 
Worse 
The treated area appearance is worse than before treatment 
í2 
Much worse 
Marked worsening in appearance from the initial condition 
í3 
Very much worse 
Obvious worsening in appearance from the initial condition 
13.1.1.6. Hexsel Cellulite Severity Scale 
The Hexsel Cellulite Severity Scale (referred to as the Hexsel CSS) is a photonumeric scale that 
looks at 5 key morphologic features of cellulite: (A) number of evident depressions, (B) depth of 
depressions, (C) morphological appearance of skin surface alterations, (D) laxity, flaccidity or 
sagging of skin, and (E) current classification scale based on medical literature including 
Nürnberger and Müller.(12,13) Each of these features is evaluated on a 4-point scale from a low 
of 0 to a high of 3 as described in Table 9 (see Appendix B). The total score is the summation of 
all 5 features. 
For subjects in the observation-only group, the Hexsel CSS will be done at month 3 and every 
3 months thereafter and at the month 12 or the end of study visit. 
For subjects who elected to have EN3835 treatments, the Hexsel CSS will be done at 3-month 
intervals during the observation phase until the study drug blind is broken in study EN3835-201. 
The Hexsel CSS assessment will be done at Screening B visit and on day 71 of the treatment 
course and at month 12 or end of study visit. 
For the subjects electing treatment (re-treatment or re-dosing) with EN3835 the Investigator or 
qualified designee will use the Hexsel CSS to assess the severity of EFP in all quadrants at 

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Screening B and the selected quadrant on day 71 of the course of treatment. All cellulite 
assessments should be made while the subject is in the standing position with relaxed gluteus 
muscles. However, when evaluating the subject for Category E (classification scale by 
Nürnberger and Müller) (13) if the subject has no evident depressions, the subject should be 
asked to contract her gluteus muscles or the pinch test should be applied (by pinching the skin 
between the thumb and index finger) so the Investigator or qualified designee can differentiate 
between scores/grades of zero (0) or I. 
Table 9: 
Hexsel Cellulite Severity Scale 
A 
Number of evident depressions 
0=none/no depressions 
1=a small amount: 1-4 depressions are visible 
2=a moderate amount: 5-9 depressions are visible 
3=a large amount: 10 or more depressions are visible 
B 
Depth of depressions 
0=no depressions 
1=superficial depressions 
2=medium depth depressions 
3=deep depressions 
C 
Morphological appearance of skin 
surface alterations 
0=no raised areas 
1=‘orange peel’ appearance 
2=‘cottage cheese’ appearance 
3=‘mattress’ appearance 
D 
Grade of laxity, flaccidity, or sagging 
skin 
0=absence of laxity, flaccidity, or sagging skin 
1=slight draped appearance 
2=moderate draped appearance 
3=severe draped appearance 
E 
Classification scale by Nürnberger and 
Müllera 
0 = zero grade = Grade or Stage 0 = There is no alteration of the 
skin surface. 
1 = first grade = Grade or Stage I = The skin of the affected area 
is smooth while the subject is standing or lying, but the 
alterations to the skin surface can be seen by pinching the skin 
or with muscle contraction. 
2= second grade = Grade or Stage II = The orange skin or 
mattress appearance is evident when standing, without the use 
of any manipulation (skin pinching or muscle contraction). 
3= third grade = Grade or Stage III = The alterations described 
in Grade or Stage II, are present together with raised areas and 
nodules. 
Source: Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity scale. J Eur Acad 
Dermatol Venereol. 2009;23(5):523-528. 
a Subjects should be evaluated in the standing position with relaxed gluteus muscles. However, if the subject has no 
evident depressions, they should be asked to contract their gluteus muscles or the pinch test should be applied (by 
pinching the skin between the thumb and index finger) in order to differentiate between grade/stage of zero (0) 
or I. 
 

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14. 
ASSESSMENT OF SAFETY 
14.1. 
Definitions 
14.1.1. 
Adverse Event 
An adverse event (AE) is any unfavorable or unintended change in body structure (signs), body 
function (symptoms), laboratory result (eg, chemistry, ECG, X-ray, etc), or worsening of a pre-
existing condition associated temporally with the use of the study medication whether or not 
considered related to the study medication. AEs will be captured once a subject has signed the 
informed consent. AEs include: 
x Changes in the general condition of the subject 
x Subjective symptoms offered by or elicited from the subject 
x Objective signs observed by the Investigator or other study personnel 
x All concurrent diseases that occur after the start of the study, including any change in 
severity or frequency of pre-existing disease 
x All clinically relevant laboratory abnormalities or physical findings that occur during 
the study 
A treatment-emergent adverse event (TEAE) is any condition that was not present prior to 
treatment with study medication but appeared following treatment, was present at treatment 
initiation but worsened during treatment, or was present at treatment initiation but resolved and 
then reappeared while the individual was on treatment (regardless of the intensity of the AE 
when the treatment was initiated).  
All AEs, including both observed or volunteered problems, complaints, signs or symptoms must 
be recorded on the AE page of the eCRF, regardless of whether associated with the use of study 
medication. This would include AEs resulting from concurrent illness, reactions to concurrent 
medication use, or progression of disease states (excluding the disease under study). A condition 
present at baseline that worsens after initiation of study treatment will be captured as an AE; the 
onset date will be the date the event worsened. The AE should be recorded in standard medical 
terminology when possible. 
14.1.2. 
Serious Adverse Event 
A serious adverse event (SAE) is defined as an AE that: 
x Results in death 
x Is immediately life-threatening (there is an immediate risk of death from the AE as it 
occurred; this does not include an AE that had it occurred in a more serious form may 
have caused death) 
x Results in or prolongs an inpatient hospitalization (Note: a hospitalization for elective 
or pre-planned surgery, procedure, or drug therapy does not constitute an SAE)  

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x Results in permanent or substantial disability (permanent or substantial disruption of 
one’s ability to conduct normal life functions)  
x Is a congenital anomaly/birth defect (in offspring of a subject using the study 
medication regardless of time to diagnosis) 
x Is considered an important medical event 
Important medical events are defined as events that, based upon appropriate medical judgment, 
may jeopardize the subject and may require medical or surgical intervention to prevent one of the 
other serious outcomes. Examples of important medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions 
that do not result in inpatient hospitalization, or the development of drug dependency or drug 
abuse. 
14.2. 
Monitoring Adverse Events 
At each visit, subjects will be queried regarding any AEs that have occurred since the last visit. 
Subjects will be asked to volunteer information concerning AEs with a non-leading question 
such as, “How do you feel?” Study site personnel will then record all pertinent information in the 
source documents and the eCRF. The study drug compliance record should also be reviewed to 
detect potential overdoses (intentional/unintentional). 
14.3. 
Relationship to Study Drug 
The degree of “relatedness” of the AE to the study medication must be described using the 
following scale:  
x Not related indicates that the AE is definitely not related to the study medication. 
x Unlikely related indicates that there are other, more likely causes and study 
medication is not suspected as a cause. 
x Possibly related indicates that a direct cause and effect relationship between study 
medication and the AE has not been demonstrated, but there is evidence to suggest 
there is a reasonable possibility that the event was caused by the study medication. 
x Probably related indicates that there is evidence suggesting a direct cause and effect 
relationship between the AE and the study medication. 
It is the Sponsor’s policy to consider “Probably related” and “Possibly related” causality 
assessments as positive causality. “Not related” and “Unlikely related” causality assessments are 
considered as negative causality. 
Assessments will be recorded on the eCRF and must indicate clearly the relationship being 
assessed. For example, an AE that appears during a placebo run-in phase would be assessed with 
respect to the placebo treatment received and/or study procedures conducted during this phase. If 
the AE continued into an active treatment phase, the relationship would be assessed for the active 
treatment phase only if the AE worsened.  

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14.4. 
Intensity Assessment 
The intensity (or severity) of AEs is characterized as mild, moderate, or severe: 
x Mild AEs are usually transient, requiring no special treatment, and do not interfere 
with the subject’s daily activities. 
x Moderate AEs introduce a low level of inconvenience or concern to the subject and 
may interfere with daily activities, but are usually ameliorated by simple therapeutic 
measures. 
x Severe AEs interrupt a subject’s usual daily activity and typically require systemic 
drug therapy or other treatment. 
When the intensity category of an AE changes, the greatest intensity during that continuous 
episode should be recorded.  
14.5. 
Reporting Adverse Events and Serious Adverse Events 
14.5.1. 
Reporting Adverse Events 
Throughout the study, AEs will be documented on the source document and on the appropriate 
page of the eCRF whether or not considered treatment-related. This includes any new signs, 
symptoms, injury or illness, including increased severity of previously existing signs, symptoms, 
injury, or illness. Conditions existing prior to screening will be recorded as part of the subject’s 
medical history. The Investigator is responsible for assessing the relationship of AEs to the study 
medication; relationship will be classified as not related, unlikely related, possibly related, or 
probably related.  
All AEs will be collected by the Investigator from the time of signing the informed consent 
through 30 days after the last dose of study medication; this includes any AEs that are ongoing at 
the time of completion/termination of the study. All ongoing AEs must be followed until 
resolution or for 30 days after the subject’s last study visit, whichever comes first. 
14.5.2. 
Reporting Serious Adverse Events 
Any SAE, including death resulting from any cause, which occurs to any subject participating in 
this study must be reported via email or fax by the Investigator using the Endo Clinical Trial 
Report Form for SAEs within 24 hours of first becoming aware of the SAE. SAEs will be 
collected by the Investigator from the time of signing the informed consent through 30 days after 
the last dose of study medication. SAEs that occur within 30 days, following cessation of the 
study treatment, or within 30 days, following premature discontinuation from the study for any 
reason, must also be reported within the same timeframe. Any SAE that is felt by the Investigator 
to be related to the study medication must be reported regardless of the amount of time since the 
last dose received. Follow-up information collected for any initial report of an SAE must also be 
reported to the Sponsor within 24 hours of receipt by the Investigator.  
All SAEs will be followed until resolution, stabilization of condition, or until follow-up is no 
longer possible. 

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In the event discussion is necessary regarding treatment of a subject, call the Medical 
Monitor (see contact information in section 3). 
All SAEs should be sent via the email address, or faxed to the fax number, provided in 
section 3. 
The Sponsor will determine whether the SAE must be reported within 7 or 15 days to regulatory 
authorities in compliance with local and regional law. If so, the Sponsor (or the Sponsor’s 
representative) will report the event to the appropriate regulatory authorities. The Investigator 
will report SAEs to the institutional review board (IRB) per their IRB policy. 
14.5.2.1. Follow-up Procedures for Serious Adverse Events 
To fully understand the nature of any SAE, obtaining follow-up information is important. 
Whenever possible, relevant medical records such as discharge summaries, medical 
consultations, and the like should be obtained. In the event of death, regardless of cause, all 
attempts should be made to obtain the death certificate and any autopsy report. These records 
should be reviewed in detail, and the Investigator should comment on any event, lab 
abnormality, or any other finding, noting whether it should be considered a serious or 
non-serious AE, or whether it should be considered as part of the subject’s history. In addition, 
all events or other findings determined to be SAEs should be identified on the follow-up SAE 
form and the Investigator should consider whether the event is related or not related to study 
drug. All events determined to be nonserious should be reported on the eCRF. 
14.6. 
Special Reporting Situations 
14.6.1. 
Adverse Events of Special Interest 
There are no AEs of special interest anticipated in this study. AEs such as bruising, ecchymosis, 
hematomas, and contusions that occur remote to the site of drug administration will be recorded 
as an AE or SAE as appropriate (see section 14.1.1, Adverse Events or section 14.1.2, Serious 
Adverse Events). 
14.6.2. 
Overdose/Misuse/Abuse 
Study drug overdose is any accidental or intentional use of study drug in an amount higher than 
the dose indicated by the protocol for that subject. Study drug compliance (see section 12.3) 
should be reviewed to detect potential instances of overdose (intentional or accidental). 
Any study drug overdose during the study should be noted on the study medication eCRF.  
An overdose is not an AE per se, however all AEs associated with an overdose should both be 
entered on the Adverse Event eCRF and reported using the procedures detailed in section 14.5.2, 
Reporting of Serious Adverse Events, even if the events do not meet seriousness criteria. If the 
AE associated with an overdose does not meet seriousness criteria, it must still be reported using 
the Endo Clinical Trial Report Form for SAEs and in an expedited manner, but should be noted 
as non-serious on the form and the Adverse Event eCRF. 

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14.6.3. 
Pregnancy 
Any uncomplicated pregnancy that occurs in a subject during this clinical study will be reported 
for tracking purposes only. All subject pregnancies that are identified during or after this study, 
where the estimated date of conception is determined to have occurred during study drug therapy 
or within 30 days of the last dose of study medication need to be reported, followed to 
conclusion, and the outcome reported, even if the subject is discontinued from the study. The 
investigator should report all pregnancies within 24 hours using the Initial Pregnancy Report 
Form, and any pregnancy-associated SAE using the SAE report form, according to the usual 
timelines and directions for SAE reporting provided in section 14.5.2. Monitoring of the 
pregnancy should continue until conclusion of the pregnancy; 1 or more Follow-up Pregnancy 
Report Form(s) detailing progress, and a Two Month Follow-up Pregnancy Report Form 
detailing the outcome, should be submitted. 
Pregnancy itself is not regarded as an AE unless there is suspicion that the investigational 
product under study may have interfered with the effectiveness of a contraceptive medication. 
Likewise, elective abortions without complications are not considered AEs. Any SAEs 
associated with pregnancy (eg, congenital abnormalities/birth defects/spontaneous miscarriages 
or any other serious events) must additionally be reported as such using the SAE report form. 
Spontaneous miscarriages should also be reported and handled as SAEs.  
Subjects should be instructed to immediately notify the investigator of any pregnancies. 
Attempts to obtain the pregnancy follow-up and pregnancy outcome information detailed above 
are necessary even if a subject discontinues treatment because of pregnancy. 
14.6.4. 
Adverse Events/Serious Adverse Events Experienced by Non-subjects Exposed 
to Study Medication 
Non-subjects are persons who are not enrolled in the study but have been exposed to study 
medication, including instances of diversion of study medication. All such AEs/SAEs occurring 
in non-subjects from such exposure will be reported to the Endo Pharmacovigilance and Risk 
Management (PVRM) Department (when the non-subject agrees) on the departmental form for 
SAEs regardless of whether the event is serious or not. Instructions for completing the form for 
events experienced by non-subjects will be provided. SAEs occurring in non-subjects exposed to 
study medication will be processed within the same SAE reporting timelines as described in 
section 14.5.2, Serious Adverse Event Reporting. Additionally, the drug accountability source 
documentation at the site should reflect this occurrence. 
14.7. 
Clinical Laboratory and Immunogenicity Determinations 
Clinical laboratory tests will be conducted according to the Schedule of Events (section 5). 
Clinical laboratory tests will be performed by a designated central laboratory. Each site will be 
provided with instructions on specimen collection, preparation, packaging and transport. Refer to 
the central laboratory manual for further information regarding sample collection, handling, and 
labeling. The results of the tests will be returned to the investigational sites.  
Clinical laboratory test data will be reviewed by the investigator, or designee, and additional 
clinical laboratory tests may be ordered at his/her discretion (eg, if the results of any clinical 
laboratory test falls outside the reference range or clinical symptoms necessitate additional 

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testing to ensure safety). Any additional testing will be performed by the designated central 
laboratory. 
The investigator will review all abnormal lab results for clinical significance. Any abnormal 
clinical laboratory test result meeting the investigator’s or Sponsor’s criteria for clinical 
significance (refer to central laboratory manual) will be recorded as an AE or SAE as appropriate 
(see section 14.1.1, Adverse Events or section 14.1.2, Serious Adverse Events). 
Laboratory results will be sent electronically to Endo for data management. 
Clinical laboratory parameters that will be measured in this study are listed in Table 10. 
Table 10: 
Clinical Laboratory Parameters 
Hematology 
Clinical Chemistry 
Urinalysis 
Hematocrit 
Hemoglobin 
Red blood cell count 
Red blood cell morphology 
White blood cell count 
Neutrophils 
Lymphocytes 
Monocytes 
Basophils 
Eosinophils 
Platelets 
Blood urea nitrogen 
Creatinine 
Total bilirubin 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Alkaline phosphatase 
Sodium 
Potassium 
Calcium 
Chloride 
Phosphate 
Serum bicarbonate 
Uric acid 
Total cholesterol 
Total protein 
Glucose 
Triglycerides 
Albumin 
Specific gravity 
Ketones 
pH 
Protein 
Blood 
Glucose 
Female subjects of childbearing potential must have a negative urine pregnancy test at 
Screening B and at treatment visits 1, 2, and 3 (section 5) to receive treatment in the study. If 
necessary, additional urine pregnancy tests can be performed at any time during the study at the 
discretion of the Investigator. Urine pregnancy test kits will be supplied by the Sponsor. 
14.7.1. 
Anti-AUX-I and Anti-AUX-II Antibodies 
Serum samples will be collected and may be tested for binding and neutralizing anti-AUX-I and 
anti-AUX-II antibodies at visit 1 through visit 4. Additionally, if a subject consents to treatment 
in the open-label study, serum samples for antibody testing will be collected before injection at 
treatment visits 1, 2, 3, and 4 of the open-label treatment period. A subset of subject samples will 
have neutralizing antibodies tested from day 1 and day 71 visits; additional samples may be 
analyzed if results or clinical signs warrant testing.  
The serum samples obtained will be processed, stored and then shipped on dry ice to the 
designated central clinical laboratory before forwarding to Endo’s appointed laboratory for the 
determination of anti-AUX-I and anti-AUX-II antibodies according to the Laboratory Manual.  

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14.8. 
Vital Signs 
Vital sign measurements will be documented as described in the Schedule of Events. These 
parameters include pulse rate, respiratory rate, systolic and diastolic blood pressure, and body 
weight. Pulse and blood pressure readings will be taken after the subject has been sitting for 
5 minutes. Height should only be recorded at Screening B.  
The investigator will review all vital sign values for clinical significance. Any vital sign value 
meeting the investigator’s or Sponsor’s criteria for clinical significance will be recorded as an 
AE or SAE as appropriate (see section 14.1.1, Adverse Events, and section 14.1.2, Serious 
Adverse Events). 
For subjects receiving treatment, vital signs will be assessed at the time points shown in Table 11 
after the subject has rested for at least 5 minutes.  
Table 11: 
Vital Signs Measurements on Injection Day 
Time Point Relative to Last Injection 
Blood Pressure, Respiratory 
Rate, and Pulse Rate 
Body Temperature 
Up to 4 hours (before treatment) 
X 
X 
Approximately 15 minutes after 
X 
 
Approximately 30 minutes after 
X 
X 
14.9. 
Electrocardiogram 
Performing a 12-lead electrocardiogram (ECG) is not necessary if Screening B visit date is 
within 12 months of obtaining an ECG during the double-blind study (EN3835-201).  
If the date of Screening B visit is later than 12 months since obtaining the ECG in study 
EN3835-201, subjects will have a resting 12-lead ECG performed during the Screening B visit. 
A qualified physician will interpret, sign, and date the ECGs. Electrocardiogram assessments 
must be “within normal limits” or interpreted as “abnormal, not clinically significant” for the 
subject to be included in the study. 
Any ECG result meeting the investigator’s or Sponsor’s criteria for clinical significance will be 
recorded as an AE or SAE as appropriate (see section 14.1.1, Adverse Events and section 14.1.2, 
Serious Adverse Events). 
14.10. 
Physical Examination 
Body weight will be collected as described in the Schedule of Events (section 5). If a subject 
desires treatment in the open-label study, a complete physical examination will be performed at 
Screening B. All examinations will be performed by a physician or health professional listed on 
the Form FDA 1572 and licensed to perform physical examinations. 
The investigator will review all physical exam findings for clinical significance. Any physical 
exam finding meeting the investigator’s or Sponsor’s criteria for clinical significance will be 
recorded as an AE or SAE as appropriate (see section 14.1.1, Adverse Events and section 14.1.2, 
Serious Adverse Events). 

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14.11. 
Other Safety Assessments 
Not applicable. 

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15. 
ASSESSMENT OF PHARMACOKINETICS 
Not applicable. 

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16. 
ASSESSMENT OF PHARMACODYNAMICS 
Not applicable. 

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17. 
STATISTICAL CONSIDERATIONS AND METHODS 
17.1. 
Determination of Sample Size 
It is estimated that approximately 95% of the 350 subjects randomized in study EN3835-201 will 
enroll in the current study for a sample size of 333. This sample size should be adequate to 
determine safety and cellulite assessments of EN3835 for subjects retreated in the same and in 
different quadrants. 
17.2. 
Subject Cohorts and Subject Populations 
Subjects will be classified into 1 of 4 different cohorts depending on where they receive the 
treatment of EN3835 in relation to where they received treatment in study EN3835-201. The 
4 cohorts are: 
1. Observational subjects only - subjects who received EN3835 in study EN3835-201 but do 
not receive any injections in the current study 
2. Re-treatment subjects - subjects who received EN3835 in study EN3835-201 and receive 
EN3835 in the current study in the same quadrant that was treated in the EN3835-201 
study. This will only be allowed for subjects who have baseline severity ratings in the 
current study at or worse than the baseline seen in study EN3835-201 for both the 
CR-PCSS and PR-PCSS of the quadrant.  
3. Re-dosing subjects - subjects who received EN3835 in study EN3835-201 and receive 
EN3835 in the current study in a quadrant different than the EN3835-treated quadrant in 
study EN3835-201. 
4. Initial treatment subjects - subjects who received placebo in study EN3835-201 and 
receive EN3835 in the current study. 
All efficacy and safety analyses will be done within the classified cohort. Durability of treatment 
effects defined as time period from injection to return to baseline cellulite severity ratings in a 
EN3835-treated quadrant will be determined for all subjects that were treated with EN3835 in 
either this study or study EN3835-201. 
17.2.1. 
Observational Population 
The Observational population includes all subjects treated with EN3835 in study EN3835-201 
who do not receive any treatment in the current study. The durability of a treatment effect and 
long-term safety analyses for subjects who receive no treatment in the EN3835-201 study will be 
performed using this population 
17.2.2. 
Safety Population 
The Safety population will include all subjects who receive at least 1 dose of EN3835 in the 
current study or in study EN3835-201. All safety analyses will be performed using this 
population. 

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17.2.3. 
Intent-to-Treat Population 
The Intent-to-Treat (ITT) population includes all subjects who enroll in the current study.  
17.2.4. 
Modified Intent-to-Treat Population 
The Modified Intent-to-Treat (mITT) population includes all subjects who receive at least 1 dose 
of EN3835 in the current study (EN3835-202) and have a baseline and at least 1 post-baseline 
assessment on both the CR-PCSS and PR-PCSS on the quadrant selected for treatment in the 
current study. All cellulite assessment analyses will be completed on this population. 
17.2.5. 
Per-Protocol Population 
The Per-Protocol population includes all subjects in the safety population who have no major 
protocol deviations. Major protocol deviations excluding subjects from this population will be 
determined at the protocol deviation assessment meeting prior to the database lock. If more than 
10% of the safety population is excluded from the per-protocol population, then all safety and 
cellulite evaluations will be repeated using the per-protocol population. 
17.3. 
Subject Disposition 
The number of subjects included in each study population will be summarized. The number and 
percentage of subjects completed and discontinued will be presented. Reasons for 
discontinuation as recorded on the eCRF will be summarized (number and percentage) for all 
subjects. 
17.4. 
Demographics and Other Baseline Characteristics 
Demographic and baseline characteristics, including age, race, and baseline values will be 
summarized for the Observational population, the Safety population, and the mITT population 
using descriptive statistics. The descriptive statistics will include frequency tables for all 
categorical response variables and number, mean, standard deviation, minimum, and maximum 
for all continuous variables.  
17.5. 
Efficacy Analyses 
Cellulite assessments (efficacy) include: 
x PR-PCSS: 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) (screening 
visit [Baseline], days 22, 43, and 71). Also will be done at day 90, day 180, day 270, 
and day 360/end of study visits for observational assessments. 
x CR-PCSS: 5-point scale ranging from 0 (no cellulite) to 4 (severe cellulite) (screening 
[Baseline], days 22, 43, and 71). Also will be done at day 90, day 180, day 270, and 
day 360/end of study visits for observational assessments. 
x Investigator rating of cellulite severity using the total scores from the Hexsel CSS 
scale: scores can range from 0 to 15 (screening [Baseline] and day 71). Also will be 
done at day 90, day 180, day 270, and day 360/end of study visits for observational 
assessments. 

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x I-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much worse) 
(day 71). Also done at day 360/end of study visit for observational assessments. 
x S-GAIS: 7-point scale ranging from 3 (very much improved) to í3 (very much 
worse) (day 71). Also done at day 360/end of study visit for observational 
assessments. 
x Subject satisfaction with cellulite treatment assessment: 5-point scale ranging from +2 
(very much satisfied) to í2 (very much dissatisfied) (day 71). Also done at 
day 360/end of study visit for observational assessments. 
All cellulite assessments will be done by treated quadrant. For initial treatment subjects who 
have 2 quadrants treated, each quadrant will be evaluated separately. 
17.5.1. 
Primary Efficacy Analysis 
The primary cellulite severity endpoint is the proportion of composite responders at day 71 
defined as subjects with an improvement in severity from baseline (Screening B visit) of at least 
2 levels of severity in the CR-PCSS and an improvement in severity from baseline of at least 2 
levels of severity in the PR PCSS. 
The primary endpoint, the proportion of composite responders with improvement of 2 or better 
on each scale (CR-PCSS and PR-PCSS) will be summarized by region treated (buttock or thigh) 
and overall with percentages. 
17.5.2. 
Secondary Efficacy Analysis 
Secondary endpoints for treated quadrants include: 
x Proportion of composite responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the CR-PCSS and an 
improvement of severity from baseline of at least 1 level of severity in the PR-PCSS. 
(day 71) 
x Proportion at each level of improvement in the PR-PCSS (day 71): 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels of severity in the PR-PCSS 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the PR-PCSS 
x Proportion at each level of improvement in the CR-PCSS (day 71): 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels of severity in the CR-PCSS (Investigator 
rated) 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 1 level of severity in the CR-PCSS (Investigator 
rated) 

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x Proportion of responders at each level of the I-GAIS (day 71): 
 Proportion of Investigator global responders defined as subjects with a response 
of 1 (improved) or better in the Investigator GAIS assessment 
x Proportion of responders at each level of the S-GAIS (day 71): 
 Proportion of subject global responders defined as subjects with a response of 
1 (improved) or better in the subject GAIS assessment 
x Proportion of responders at each level of the subject satisfaction with cellulite 
treatment (day 71) 
x Change in the Hexsel CSS total score from screening visit to day 71 
x All secondary endpoints, except the Hexsel CSS total score, will be summarized by 
treated region (buttock or thigh) and overall using percentages. Change in Hexsel 
CSS total score will be summarized by treated region (buttock or thigh) and overall 
with descriptive statistics for continuous variables. 
Observational endpoints include: 
x Proportion of 2-point composite responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point composite responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 2-point CR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point CR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 2-point PR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 
x Proportion of 1-point PR-PCSS responders as defined by responses in the quadrant 
treated in study EN3835-201 who either maintained response, lost response but did 
not return to the baseline of study EN3835-201, or returned to the baseline of study 
EN3835-201. 

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x Duration of response as defined by the time from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant treated in study EN3835-201 until the time 
that the treated quadrant returned to the baseline PR-PCSS and CR-PCSS ratings 
from study EN3835-201. 
x CR-PCSS change from the study EN3835-201 baseline at day 71 of study 
EN3835-201, and days 90, 180, 270, and 360/end of study of the current study 
(EN3835-202). 
x PR-PCSS change from the study EN3835-201 baseline at day 71 of study 
EN3835-201, and days 90, 180, 270, and 360/end of study of the current study 
(EN3835-202). 
x Hexsel CSS total score changed from the study EN3835-201 baseline at day 71 of 
study EN3835-201 and day 360/end of study of the current study (EN3835-202).  
x Proportion of responses at each level of the I-GAIS (day 360/end of study): 
 Proportion of Investigator global responders defined as subjects with a response 
of 1 (improved) or better in the Investigator GAIS assessment 
 Change in I-GAIS assessment from day 71 of study EN3835-201 and day 360/ 
end of study of the current study (EN3835-202 
x Proportion of responses at each level of the S-GAIS (day 360/end of study): 
 Proportion of subject global responders defined as subjects with a response of 
1 (improved) or better in the subject GAIS assessment 
 Change in S-GAIS assessment from day 71 of study EN3835-201 and day 360/ 
end of study of the current study (EN3835-202) 
x Proportion of responses at each level of the subject satisfaction with cellulite 
treatment (day 360/end of study) 
 Change in subject satisfaction assessment from day 71 of study EN3835-201 and 
day 360/end of study of the current study (EN3835-202) 
For quadrants treated in the current study the following observational endpoints will be analyzed: 
x Proportion of 2-point composite responders as defined by the responses in the 
quadrant treated in this current study (EN3835-202) who either maintained response, 
lost response but did not return to the study EN3835-202 baseline, or returned to the 
study EN3835-202 baseline. 
x Proportion of 1-point composite responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 2-point CR-PCSS responders as defined by the responses in the 
quadrant treated in this current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 

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x Proportion of 1-point CR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 2-point PR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x Proportion of 1-point PR-PCSS responders as defined by the responses in the 
quadrant treated in the current study who either maintained response, lost response 
but did not return to the study EN3835-202 baseline, or returned to the study 
EN3835-202 baseline. 
x CR-PCSS change from the study EN3835-202 baseline at day 71, day 90, day 180, 
day 270, and day 360/end of study. 
x PR-PCSS change from the study EN3835-202 baseline at day 71, day 90, day 180, 
day 270, and day 360/end of study. 
x Duration of response as defined by the time from onset of change from baseline of 
PR-PCSS and CR-PCSS in the quadrant treated in the current study until the time that 
the treated quadrant returned to the baseline PR-PCSS and CR-PCSS ratings from 
study EN3835-202. 
17.6. 
Safety Analyses 
The following variables are safety endpoints. 
x AEs: Mapped to preferred term using the Medical Dictionary for Regulatory 
Activities (MedDRA) 
x Injection site reactions/local tolerability in selected quadrant (through subject and 
Investigator reporting) 
x Vital signs 
x Laboratory testing 
AEs will be summarized by treatment group. AE duration will be summarized using descriptive 
statistics by treatment group. 
Descriptive statistics will be presented for each clinical laboratory test for the actual and change 
from screening at each visit by treatment group and vital signs for the actual and change from 
day 1 pre-injection for each injection day at each visit by treatment group. 
17.6.1. 
Prior, Concomitant, and Follow-up Medication 
The World Health Organization (WHO) Drug Dictionary will be used to classify prior and 
concomitant medications by therapeutic class. The version used in this study will be stated in the 
Data Management Plan. Prior medication will be defined as any medication with a start date 
prior to the day 1 date and are collected at the screening visit and upon admission to the clinic on 

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day í1. Concomitant medication is defined as any medication with a start date on or after the 
day 1 date or reported as ongoing. Any medications started after the last dose of study drug will 
be considered as follow-up medications 
Prior and concomitant medication use will be summarized descriptively by the number and 
percentage of subjects receiving each medication within each therapeutic class. Multiple use of 
the same medication by a subject will be counted only once. 
17.6.2. 
Study Drug Exposure 
For those subjects that elect, are eligible, and do receive treatment, the number of injections will 
be summarized by counts and percentages. The number of dimples treated will be summarized 
with counts and percentages.  
17.6.3. 
Measurement of Treatment Compliance 
All doses are administered while the subjects are at the investigators’ sites. Any dose that was 
not administered per protocol will recorded as a protocol deviation by the Investigator. 
17.6.4. 
Adverse Events 
The MedDRA will be used to code AEs. The version used in this study will be stated in the Data 
Management Plan. 
An AE (classified by preferred term) that started during the treatment period will be considered a 
TEAE if it was not present prior to the first dose of study drug, or was present prior to the first 
dose of study drug but increased in intensity during the treatment period. If more than 1 AE is 
reported prior to the first dose of study drug and coded to the same preferred term, then the AE 
with the greatest intensity will be used as the benchmark for comparison to the AEs occurring 
during the treatment period which were also coded to that preferred term. Any AE present prior 
to the first dose of study drug that increases in intensity during the treatment period will be 
re-entered with a new start date of the date of increased intensity.  
Descriptive statistics (the number and percentage) for subjects reporting TEAEs in each 
treatment group will be tabulated by system organ class and preferred term; by system organ 
class, preferred term, and severity; and by system organ class, preferred term, and relationship to 
study drug. If more than 1 AE is coded to the same preferred term for the same subject, the 
subject will be counted only once for that preferred term using the most severe and most related 
occurrence for the summarization by severity and by relationship to the study drug. 
SAEs and AEs leading to premature discontinuation of study drug will be summarized by 
preferred term and dose received. Listings will be presented for subjects with SAEs, subjects 
with AEs leading to discontinuation, and subjects who die (if any). 
17.6.5. 
Vital Signs 
Descriptive statistics for vital signs (eg, systolic and diastolic blood pressure, pulse rate, and 
body weight) and their changes from baseline at each visit and at the end of treatment visit will 
be presented.  
Vital sign values are potentially clinically significant (PCS) if they meet both the observed value 
criteria and the change from baseline criteria. The criteria for PCS vital sign values will be 

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detailed in the Statistical Analysis Plan (SAP). A listing of all AEs for subjects with PCS vital 
signs will also be provided. 
17.6.6. 
Clinical Laboratory Parameters 
Descriptive statistics for clinical laboratory values in International System of Units (SI units) and 
changes from baseline will be presented for each clinical laboratory parameter. 
The number and percentage of subjects with PCS post-baseline clinical laboratory values will be 
tabulated. The criteria for PCS laboratory values will be detailed in the SAP. A listing of all AEs 
for subjects with PCS laboratory values will also be provided. 
17.7. 
Immunogenicity Analyses 
Immunogenicity variables include anti-AUX-I/anti-AUX-II binding antibody results. Binding 
antibody levels will be determined from samples collected on days 1, 22, 43, and 71 during the 
treatment phase and days 90, 180, 270 and 360 during the observational phase. 
Descriptive statistics (percent of positive measurements and average antibody level) will be 
presented for anti-AUX-I and anti-AUX-II antibody levels at each time point by region treated 
and overall. Average antibody levels will be summarized on logarithmically transposed titer 
values. 
17.8. 
Pharmacokinetic Analyses 
Not applicable. 
17.9. 
Interim Analysis 
Two (2) interim analyses are planned. Following the breaking of the study drug blind in study 
EN3835-201, all follow-up safety data gathered prior to that time will be analyzed. The second 
interim analyses will occur following the day 71 visit for all subjects treated with EN3835 in the 
current study. A preliminary data lock will be done on all treated quadrants and cellulite 
assessment and safety analyses will be done. The official database lock will occur after the last 
day 360/end of study observational visit and all observational analyses on treated quadrants will 
be done. 
17.10. 
Statistical Software 
Statistical analyses will be performed using Version 9.3 (or higher) of SAS® (SAS Institute, 
Cary, North Carolina). 

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accountability during monitoring visits. When instructed by Endo, the Investigator agrees to 
return all original containers of unused study drug to Endo or its designee. 
18.5.1. 
Study Drug Handling and Disposal 
The Investigator is responsible for recording the receipt and use of all drug supplied and for 
ensuring the supervision of the storage and allocation of these supplies. All unused study drug 
will be returned, and unit counts will be performed whenever medication is returned. The site 
must account for all study drug received. The Investigator agrees not to supply study drug to any 
person except to those subjects enrolled in the study. At the end of the study, all unused drug 
supplies will be returned to Endo as instructed by the clinical monitor. 

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19. 
DIRECT ACCESS TO SOURCE DATA/DOCUMENTS 
19.1. 
Source Documents 
Source documents include but are not limited to original documents, data and records such as 
hospital/ medical records (including electronic health records), clinic charts, lab results, subject 
diaries, data recorded in automated instruments, microfilm or magnetic media, and pharmacy 
records, etc. At a minimum, all data required to be collected by the protocol should have 
supporting source documentation for entries in the eCRF, unless the protocol specifies that data 
can be recorded directly on/in the eCRF or other device. 
19.2. 
Study Monitoring 
A representative of Endo Pharmaceuticals Inc. will meet with the Investigator and his/her staff 
prior to the entrance of the first subject to review study procedures and methods of recording 
findings in the eCRF.  
After enrollment of the first subject, an Endo Pharmaceuticals Inc. representative will be 
assigned to periodically monitor each Investigator site for study progress and to verify that 
standards of Good Clinical Practice (GCP) were followed. The Investigator is expected to 
prepare for the monitor visit, ensuring that all source documents, completed eCRFs, signed 
consent forms, and other study related documents are readily available for review. 
19.3. 
Audits and Inspections 
The Investigator shall permit audits and inspections by the Sponsor, its representatives and 
members of regulatory agencies. The investigator should immediately notify the Sponsor of an 
upcoming FDA or other regulatory agency inspection. 
19.4. 
Institutional Review Board (IRB) 
The Investigator shall permit members of the IRB/IEC to have direct access to source 
documents. 
19.5. 
Data Recording and Documentation 
All data recordings and source documentation (including electronic health records) must be made 
available to the Sponsor (or designee), FDA and any other regulatory agencies that request 
access to study records, including source documents, for inspection and copying, in keeping with 
federal and local regulations. 

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20. 
QUALITY CONTROL AND QUALITY ASSURANCE 
Steps to assure the accuracy and reliability of data include the selection of qualified principal 
investigators and appropriate study centers, review of protocol procedures with the principal 
investigators and associated personnel prior to start of the study, and periodic monitoring visits 
conducted by the Sponsor or Sponsor representative. Significant and/or repeated non-compliance 
will be investigated and remedial action instituted when appropriate. Failure to comply with 
remedial actions may result in investigator site termination and regulatory authority notification. 
The Sponsor or its designee will utilize qualified monitors to review and evaluate activities 
conducted at Investigator Sites. 
The data will be entered into the clinical study database and verified for accuracy, following 
procedures defined by the Sponsor (or designee). Data will be processed and analyzed following 
procedures defined by the Sponsor (or designee). 
The study will be monitored and/or audited at intervals to ensure that the clinical study is 
conducted and data are generated, documented (recorded), and reported in compliance with the 
Study Protocol; International Conference on Harmonisation (ICH), E6 consolidated guidelines; 
and other applicable regulations. The extent, nature, and frequency of monitoring and/or audits 
will be based on such considerations as the study objectives and/or endpoints, the purpose of the 
study, study design complexity, and enrollment rate. At the conclusion of a program, a 
compliance statement will be generated by the Sponsor (or designee) listing all audit activities 
performed during the clinical study. 

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21. 
ETHICS 
21.1. 
Ethics Review 
Approval by the IRB/IEC prior to the start of the study will be the responsibility of the 
Investigator. A copy of approval documentation will be supplied to Endo Pharmaceuticals Inc. 
along with a roster of IRB members that demonstrates appropriate composition (a Department of 
Health and Human Services [DHHS] Assurance Number will satisfy this requirement).  
The study protocol, the informed consent form, advertisements, materials being provided to 
subjects and amendments (if any) will be approved to IRB/IECs at each study center in 
conformance with ICH E6, the Code of Federal Regulations (CFR), Title 21, Part 56 and any 
other applicable local laws. The Investigator is responsible for supplying the IRB/IEC with a 
copy of the current IB, Package Insert, or SPC as well as any updates issued during the study. 
During the course of the study, the Investigator will provide timely and accurate reports to the 
IRB/IEC on the progress of the study, at intervals not exceeding 1 year (or as appropriate), and 
will notify the IRB/IEC of SAEs or other significant safety findings, per the policy of the 
IRB/IEC. At the conclusion of the study, the Investigator will submit a final report or close out 
report to the IRB/IEC and provide a copy to Endo Pharmaceuticals Inc. 
Any amendment to this protocol will be provided to the Investigator in writing by Endo 
Pharmaceuticals Inc. No protocol amendment may be implemented (with the exceptions noted 
below) before it has been approved by the IRB and the signature page, signed by the 
Investigator, has been received by Endo Pharmaceuticals Inc. Where the protocol is amended to 
eliminate or reduce the risk to the subject, the amendment may be implemented before IRB 
review and approval. However, the IRB must be informed in writing of such an amendment and 
approval obtained within reasonable time limits. Deviating from the protocol is permitted only if 
absolutely necessary for the safety or clinical management of the subject, and must be 
immediately reported to Endo Pharmaceuticals Inc.  
The Investigator will be responsible for supplying updated safety and/or study information to 
study subjects as it becomes available. 
21.2. 
Ethical Conduct of the Study 
This clinical study is designed to comply with the ICH Guidance on General Considerations for 
Clinical Trials (62 FR 6611, December 17, 1997), Nonclinical Safety Studies for the Conduct of 
Human Clinical Trials for Pharmaceuticals (62 FR 62922, November 25, 1997), Good Clinical 
Practice: Consolidated Guidance (62 FR 25692, May 9, 1997) and 21 CFR parts 50, 54, 56, and 
312. 
The study will be conducted in full compliance with ICH E6, the FDA guidelines for GCP and in 
accordance with the ethical principles that have their origins in the Declaration of Helsinki 
defined in 21 CFR, 312.120. 

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21.3. 
Subject Information and Consent 
Subjects, after having the study explained to them and an opportunity to have their questions 
answered sufficiently, will give voluntary and written informed consent (in compliance with ICH 
E6, 4.8 and 21 CFR Parts 50 and 312) before participating in any study-related procedures. The 
consent shall be written in a language understandable to the subject. Subjects unable to read 
(illiterate) shall have the consent process performed in the presence of an independent witness 
who shall also sign the consent. Each subject will read, assent understanding, and sign an 
instrument of informed consent after having had an opportunity to discuss the study and consent 
documents with the Investigator before signing, and will be made aware that she may withdraw 
from the study at any time.  
In addition to obtaining informed consent, the Investigator is responsible for obtaining any 
additional documentation to demonstrate compliance with local privacy laws applicable to 
activities performed.  
The consent process shall be recorded in source documents. Signed copies of the informed 
consent will be given to the Subject and originals will be placed in the Investigator study files.  
A unique Subject identification number will be assigned according to section 12.1.3 at the time 
that the Subject signs the informed consent form. 
 

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22. 
DATA HANDLING AND RECORDINGKEEPING 
22.1. 
Data Collection 
Data collection will involve the use of an EDC system to which only authorized personnel will 
have access. The system will be secured to prevent unauthorized access to the data or the system. 
This will include the requirement for a user ID and password to enter or change data. The level 
of access to the EDC system will be dependent on the person’s role in the study. 
Study data will be collected from source documents and entered into an eCRF within the EDC 
system. The Investigator will be responsible for ensuring the eCRFs are completed in a timely 
manner relative to the subject’s visit. In addition to periodic monitoring occurring within the 
system by a Sponsor monitor, programmatic edit checks will be used to review EDC data for 
completeness, logic, and adherence to the study protocol. As a result of this monitoring and these 
checks, queries may be issued electronically to the clinical study sites and closed electronically 
by the monitor, data management staff or authorized staff at the study site. Additionally, the 
Investigator will review eCRFs, ensure all missing or corrected data is provided and will sign the 
eCRF pages with an electronic signature.  
An electronic audit trail will be maintained in the EDC system to track all changes made to data 
entered in the eCRF. Data will be retrievable in such a fashion that all information regarding 
each individual subject is attributable to that subject. Unless otherwise indicated, all data 
captured in the eCRF must first be captured in source documents. Data that can be directly 
recorded in the eCRF will be clearly identified in the section(s) of the protocol that describes the 
assessment(s). 
In addition, any contact with the subject via telephone or other means that provide significant 
clinical information must be documented in source documents as described above. 
22.2. 
Study Documentation 
Upon study completion, the Investigator will be provided with complete electronic copies of the 
CRF data for his/her files.  
 

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23. 
REPORTING AND PUBLICATION 
All data generated in this study are the property of Endo. An integrated clinical and statistical 
report will be prepared at the completion of the study. 
Publication of the results by the Investigator will be subject to mutual agreement between the 
Investigator and Endo. 

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24. 
INVESTIGATOR OBLIGATIONS 
24.1. 
Regulatory Documents 
The Investigator is responsible for creating and/or maintaining all study documentation required 
by 21CFR 50, 54, 56 and 312, ICH, E6 section 8, as well as any other documentation defined in 
the protocol or the Investigator Agreement. The Investigator must maintain the documentation 
relating to this study and permit Endo Pharmaceuticals Inc. or a member of a regulatory agency 
access to such records. 
The Investigator must provide the following key documents to Endo Pharmaceuticals Inc. prior 
to the start of the study: 
x A completed and signed Form FDA1572. If during the course of the study any 
information reported on the Form FDA 1572 changes, a revised Form FDA1572 must 
be completed and returned to Endo Pharmaceuticals Inc. for submission to the FDA. 
For studies executed outside the United States, documentation required by the 
governing regulatory authority may be substituted for the Form FDA 1572. 
x A fully executed contract 
x The Investigator’s Statement page in this protocol signed and dated by the 
Investigator and any subsequent amendment signature pages 
x The IB acknowledgment of receipt page 
x Curricula vitae for the Principal Investigator and all Sub-Investigators listed on Form 
FDA 1572, including a copy of each physician’s license (if applicable) 
x A copy of the original IRB/IEC approval for conducting the study. If the study is 
ongoing, renewals must be submitted at yearly intervals or shorter intervals defined 
by the IRB/IEC. All subsequent modifications must be submitted and approved by the 
IRB, as described in section 21.1  
x A copy of the IRB/IEC-approved informed consent form 
x A list of IRB/IEC members or DHHS Assurance Number 
x Laboratory certifications and normal ranges (if local labs are required by the protocol) 
x A financial disclosure agreement completed and signed by the Investigator and all 
Sub-Investigators listed on Form FDA 1572. Investigator site staff that submitted an 
initial financial disclosure are also responsible for informing Endo Pharmaceuticals 
Inc. of any changes to their initial financial disclosure form 1 year after the 
completion of the study. 
A complete list of required regulatory documents will be supplied by Endo Pharmaceuticals Inc. 
or its representative. 

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24.2. 
Delegation of Responsibilities and Adequate Resources 
The Investigator should have adequate time to conduct the study properly and should have an 
adequate number of qualified staff to assist with the conduct of the study. The Investigator shall 
delegate tasks only to individuals qualified by education, training and experience to perform the 
delegated tasks. The Investigator shall have direct oversight of all delegated activities and shall 
document delegation of responsibilities. The Investigator is responsible for ensuring all delegated 
staff have been properly trained on the protocol and their assigned study responsibilities. 
24.3. 
Medical Care of Study Subjects 
The Investigator and/or a qualified sub-investigator shall be responsible for the subjects’ medical 
care. Any unrelated medical condition discovered during the course of the study should be 
communicated to the subject so that they may seek appropriate medical care. The Investigator 
will report all AEs as required by the protocol (section 14.5). The Investigator will inform study 
subjects of new information regarding the study drug as it becomes available. 
24.4. 
Use of Investigational Materials 
The Investigator will acknowledge that the study drug supplies are investigational and as such 
must be used strictly in accordance with the protocol and only under the supervision of the 
Principal Investigator or Sub-Investigators listed on Form FDA1572 (or other regulatory 
document, depending on region). Study drug must be stored in a safe and secure location. At 
study initiation, a representative from Endo Pharmaceuticals Inc. will inventory the study drug at 
the site. The Investigator must maintain adequate records documenting the receipt and 
disposition of all study supplies. Endo Pharmaceuticals Inc. or its representative will supply 
forms to document total inventory as well as subject specific accountability. The Investigator is 
responsible for monitoring subject’s use of the study drug to ensure compliance with the 
protocol. All study supplies shall be returned to Endo Pharmaceuticals Inc. or its designee (this 
may include empty packaging such as bottles and blister cards). It is the Investigator’s 
responsibility to ensure that subjects return their medication. 
24.5. 
Retention of Records 
Federal and local regulations require that the Investigator retain a copy of all regulatory 
documents and records that support the data for this study (eg, informed consents, laboratory 
reports, source documents, study drug dispensing records) for whichever of the following is the 
longest period of time: 
x A period of 2 years following the final date of approval by the FDA or other 
regulatory agency of the study drug for the purposes that were the subject of the 
investigation; or 
x A period of 5 years following the date on which the results of the investigation were 
submitted to the FDA or other regulatory agency in support of, or as part of, an 
application for a research or marketing permit for the study drug for the purposes that 
were the subject of the investigation 
Endo will notify Investigators once one of the above 2 timeframes has been satisfied. 

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If the investigation does not result in the submission of the data in support of, or as part of, an 
application for a research or marketing permit, records must be retained for a period of 2 years 
following notification by Endo Pharmaceuticals Inc. that the entire clinical investigation (not 
merely the Investigator’s portion) is completed, terminated, or discontinued or 2 years following 
withdrawal of the Investigational New Drug application (IND).  
If the Investigator retires, relocates, or for other reasons withdraws from the responsibility of 
keeping the study records, custody must be transferred to a person who will accept the 
responsibility. Endo must be notified in writing of the name and address of the new custodian. 
Study records should not be destroyed without consultation with Endo Pharmaceuticals Inc. 
24.6. 
Subject Confidentiality 
All subject records submitted to Endo Pharmaceuticals Inc. or its designee will be identified only 
by initials and code number. Subjects’ names are not to be transmitted to Endo Pharmaceuticals 
Inc. The Investigator will keep a Master Subject List on which the identification number and the 
full name, address, and telephone number of each subject are listed. It is the Investigators’ 
responsibility to inform study subjects that representatives of the Sponsor, FDA, or other 
regulatory agencies may review all records that support their participation in the study. The 
Investigator will adhere to all privacy laws to which she is subject. 
 

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25. 
TERMINATION OF STUDY 
The Sponsor has the right to suspend or terminate the study at any time. The study may be 
suspended or terminated for any reason. 

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26. 
INVESTIGATOR’S AGREEMENT 
I agree to conduct the study in accordance with the protocol, and with all applicable government 
regulations and Good Clinical Practice guidance. 
 
 
 
 
_____/_____/______ 
Investigator’s Signature 
Date 
 
 
 
Typed Name of Investigator 
 

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27. 
REFERENCES 
1. Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part I. Pathophysiology. 
J Am Acad Dermatol 2010;62(3):361-370. 
2. Hexsel D, de Oliveira Dal’Forno T, Mazzuco R. Definition, clinical aspects, 
classifications, and diagnostic techniques. In: Goldman MP, Hexsel D, eds. Cellulite: 
Pathophysiology and Treatment. 2nd ed. New York, NY: Informa Healthcare; 
2010:13-21. 
3. Rawlings AV. Cellulite and its treatment. Int J Cosmetic Sci. 2006;28(3):175-190. 
4. Terranova F, Berardesca E, Maibach H. Cellulite: nature and aetiopathogenesis. Int J 
Cosmetic Sci. 2006;28(3):157-167. 
5. Avram MM. Cellulite: a review of its physiology and treatment. J Cosmet Laser Ther. 
2004;6(4):181-185. 
6. Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part II. Advances and 
controversies. J Am Acad Dermatol 2010;62(3):373-384. 
7. Collis N, Elliot LA, Sharpe C, Sharpe DT. Cellulite treatment: a myth or reality: a 
prospective randomized, controlled trial of two therapies, endermologie and 
aminophylline cream. Plast Reconstr Surg. 1999;104(4):1110-1114. 
8. Hexsel DM, Mazzuco R. Subcision: a treatment for cellulite. Int J Dermatol. 
2000;39(7):539-544. 
9. Boyce S, Pabby A, Chuchaltkaren P, Brazzini B, Goldman MP. Clinical evaluation of a 
device for the treatment of cellulite: Triactive. Am J Cosmet Surg. 2005;22:233-237. 
10. DiBernardo BE. Treatment of celllulite using a 1440-nm pulsed laser with one-year 
follow-up. Aesthet Surg J. 2011;31(3):328-341. 
11. Dagum AB, Badalamente MA. Collagenase injection in the treatment of cellulite. Plas 
Reconst Surg. 2006;118(suppl 4):53. 
12. Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity scale. 
J Eur Acad Dermatol Venereol. 2009;23(5):523-528. 
13. Nürnberger F, Müller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol. 
1978;4(3):221-229. 
 

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LIST OF APPENDICES 
Appendix A  Documents Required Prior to Initiation of the Study 
Appendix B  Hexsel DM, Dal’Forno T, Hexsel CL. A validated photonumeric cellulite severity 
scale. J Eur Acad Dermatol Venereol. 2009;23(5):523-528. 
Appendix C  Reference Images for Hexsel Severity Ratings 
Appendix D 
Patient’s Instructions for Use of the PR-PCSS 

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APPENDIX A. DOCUMENTS REQUIRED PRIOR TO INITIATION OF 
THE STUDY 
As a Sponsor of a clinical study, Endo Pharmaceuticals Inc. has an obligation to ensure that the 
study will be conducted by a qualified Investigator with sufficient resources of time, personnel, 
and physical facilities to conduct the study and to ensure that the Investigator understands and 
agrees to comply with the protocol, applicable regulations, policies, and procedures. The 
following documentation is required: 
From the Principal Investigator 
1. A signed agreement to perform the study per protocol (the signature page will suffice). 
2. A signed Letter of Financial Agreement (including confidentiality statement). 
3. Name(s) of the Principal Investigator and of all sub-Investigator(s) 
4. All address(es) of the clinical site(s). 
5. A current medical license valid where he/she practices and a current curriculum vitae for 
the Principal Investigator (signed and dated) and all sub-investigators, to contain at least 
the following elements: 
a. For physicians: 
i. Date of degree in Medicine 
ii. Name of the Institution granting the degree in Medicine. 
iii. Previous clinical postings with dates. 
b. For non-physician allowed by national law or regulations to act as clinical 
Investigators: 
i. Date and description of most advanced degree. 
ii. Name of the Institution granting the degree in number (i). 
iii. Other accreditation or qualifications relevant to the study. 
iv. Previous postings with dates. 
v. Name and qualification (see 5a above) of the physician or dentist in charge of 
study subjects. 
Note: If a non-physician is serving as Principal Investigator, then a qualified physician 
must be assigned as a sub-Investigator for the trial, to be responsible for all trial-related 
medical decisions. 
6. Written notification of Institutional Review Board/Independent Ethics Committee/Human 
Research Ethics Committee (IRB/IEC/HREC) approval. The minimum requirements are 
as follows: 
a. Dated letter, including: 
i. The date on which the meeting for the review of the study protocol took place. 
ii. Study protocol/amendment number, and version date 

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iii. A clear statement of approval of the protocol and the informed consent text with 
version date, and authorization for the study to proceed. 
iv. If the Investigator or any sub-Investigator is a part of the IRB/IEC/HREC 
Review Board, assurance that the Investigator abstained from voting at the 
meeting(s) when the study was discussed.  
b. A dated list of the members and their occupations. 
c. A specimen copy of the Committee-approved informed consent text to be used in the 
study. 
7. Food and Drug Administration (FDA) Form 1572 (for studies submitted under a US 
Investigational New Drug application [IND]). 
8. Financial Disclosure Certification or Certification of Non-Disclosure (for studies to be 
submitted for a US New Drug Application/Biologics License Application [NDA/BLA]). 
Other 
Any other documentation required by national law or regulations to be in the possession of the 
Sponsor or the Investigator for study participation or study initiation. 
 

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APPENDIX B. HEXSEL DM, DAL’FORNO T, HEXSEL CL. A 
VALIDATED PHOTONUMERIC CELLULITE SEVERITY 
SCALE. J EUR ACAD DERMATOL VENEREOL. 
2009;23(5):523-528. 
 

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APPENDIX D. PATIENT INSTRUCTIONS FOR USE OF PATIENT-
REPORTED PHOTONUMERIC CELLULITE SEVERITY 
SCALE (PR-PCSS) 
 

Protocol: EN3835-202 
SAP Module 1 
Version: 1.0 
 
 
1-Aug-2018 
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Page 2 
 
 
 
TABLE OF CONTENTS 
0. 
REVISION HISTORY .................................................................................................7 
1. 
STUDY DESIGN .........................................................................................................7 
1.1. 
Description of Study Design .........................................................................................7 
1.2. 
Schedule of Study Assessments....................................................................................8 
1.3. 
Study Objectives .........................................................................................................14 
1.3.1. 
Primary Objective .......................................................................................................14 
1.3.2. 
Secondary Objectives .................................................................................................14 
1.4. 
Study Medication ........................................................................................................14 
1.5. 
Randomization and Unblinding ..................................................................................15 
1.6. 
Interim Analysis ..........................................................................................................15 
1.7. 
Sample Size Justification ............................................................................................15 
2. 
ANALYSIS POPULATIONS AND PHASES ...........................................................15 
3. 
STATISTICAL METHODS AND CONSIDERATIONS .........................................16 
3.1. 
Descriptive Statistics ..................................................................................................16 
3.2. 
Baseline Considerations ..............................................................................................17 
3.3. 
Protocol Deviation Subjects Handling ........................................................................17 
3.4. 
Reporting Precision ....................................................................................................17 
4. 
SUBJECT DISPOSITION ..........................................................................................17 
5. 
DEMOGRAPHICS AND OTHER BASELINE CHARACTERISTICS ...................18 
6. 
EFFECTIVENESS ANALYSES................................................................................18 
6.1. 
Cellulite assessments ..................................................................................................18 
6.2. 
Effectiveness Analysis ................................................................................................18 
6.2.1. 
Composite Endpoints ..................................................................................................18 
6.2.2. 
Other Cellulite Assessment Endpoints .......................................................................19 
6.2.3. 
Observation Endpoints ................................................................................................19 
6.3. 
Durability of Treatment Effect ...................................................................................20 
7. 
SAFETY ANALYSES ...............................................................................................20 
7.1. 
Prior, Concomitant, and Follow-up Medications .......................................................21 
7.2. 
Study Drug Exposure ..................................................................................................21 
7.3. 
Treatment Administration and Compliance ................................................................21 
7.4. 
Adverse Events ...........................................................................................................22 

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7.5. 
Vital Signs ..................................................................................................................22 
7.6. 
Clinical Laboratory Parameters ..................................................................................23 
7.7. 
Immunogenicity Analyses ..........................................................................................23 
8. 
HANDLING OF MISSING DATA ............................................................................24 
8.1. 
Handling Missing Data on Efficacy Variable .............................................................24 
8.2. 
Handling Partial or Missing Dates on AE, CM, and MH ...........................................24 
9. 
CHANGES TO PLANNED ANALYSES..................................................................24 
APPENDIX A. PCI CRITERIA..................................................................................................25 
 
 

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LIST OF TABLES 
Table 1: 
Abbreviations ................................................................................................................5 
Table 2: 
Schedule of Observation Assessments .........................................................................9 
Table 3: 
Treatment Session Assessments .................................................................................11 
Table 4: 
Assessments for Durability (Beyond Day 360) ..........................................................13 
Table 5: 
EN3835 Administration ..............................................................................................15 
Table 6: 
Clinical Laboratory Parameters ..................................................................................23 
 
 

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LIST OF ABBREVIATIONS 
Table 1: 
Abbreviations 
Abbreviation 
Definition 
AE 
Adverse event 
AESI 
Adverse Events of Special Interest 
ALT 
Alanine aminotransferase 
AST 
Aspartate aminotransferase 
AUX-I 
Clostridial Class I Collagenase 
AUX-II 
Clostridial Class II Collagenase 
BMI 
Body mass index 
bpm 
Beats per minute 
brpm 
Breaths per minute 
BUN 
Blood urea mitrogen 
CR-PCSS 
Clinician Reported Photonumeric Cellulite Severity Scale 
CSS 
Cellulite Severity Scale 
ECG 
Electrocardiogram 
eCRF 
Electronic Case Report Form 
EFP 
Edematous fibrosclerotic panniculopathy 
EN3835 
Collagenase clostridium histolyticum 
EOS 
End of Study 
EOT/ET 
End of Treatment/Early Termination 
GAIS 
Global Aesthetic Improvement Scale 
I-GAIS 
Investigator Global Aesthetic Improvement Scale 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
MH 
Medical history 
mL 
Milliliter 
mmHg 
Millimeters of mercury 
mmol 
Millimoles 
PCI 
Potentially clinically importance/important 
PR-PCSS 
Patient Reported Photonumeric Cellulite Severity Scale 

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Table 1: 
Abbreviations (Continued) 
Abbreviation 
Definition 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
S-GAIS 
Subject Global Aesthetic Improvement Scale 
TEAE 
Treatment-emergent adverse event  
ULN 
Upper limit of normal 
ȝmol 
Micromoles 
WHO 
World Health Organization 
 

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0. 
REVISION HISTORY 
1. 
STUDY DESIGN 
1.1. 
Description of Study Design 
This clinical study is a multicenter, open-label extension study. Subjects who completed the 
entire double-blind, placebo-controlled, parent trial (EN3835-201) and sign an informed consent 
form will be eligible to participate in this study. 
After the Sponsor has broken the EN3835-201 study drug blind, subjects enrolled in the open-
label study will have the following options: 
x To have no EN3835 treatments in study EN3835-202 
x If received EN3835 in study EN3835-201, may elect to have a qualifying quadrant 
other than the one treated with EN3835 in study EN3835-201 (termed re-dosing) 
x If received EN3835 in study EN3835-201 and the cellulite severity scores of the 
treated quadrant have returned to or are higher than EN3835-201 baseline scores, may 
elect to have the previously treated quadrant retreated with EN3835 (termed 
re-treatment) 
x If received placebo in study EN3835-201, may elect to have a qualifying quadrant 
treated with EN3835; also may elect to have a second qualifying quadrant treated 
with EN3835 after completing the treatment course  
Following completion of safety and cellulite assessments at Day 71 of the double-blind study 
(EN3835-201), subjects will be asked if they wish to continue in the open-label extension to the 
double-blind study (Screening A). Subjects enrolled in study EN3835-202 who elect to receive 
EN3835 treatment (either re-treatment, re-dosing, or a first treatment) must meet specific 
inclusion and exclusion criteria for eligibility during re-screening (Screening B) prior to EN3835 
dosing.  
Previously placebo-treated subjects will have the option to receive a second course of EN3835 in 
the same or different qualifying quadrant after at least 28 days following the end of the first 
treatment course (eg, the Screening B visit of second quadrant could be performed on Day 71 
after treating the first quadrant). The selected quadrant can be re-treatment or re-dosing. 
At each treatment course, subjects will receive 3 treatment sessions (Day 1, Day 22, and Day 43) 
unless the chosen quadrant has no further treatable edematous fibrosclerotic panniculopathy 
(EFP) dimples and the Investigator rates the quadrant a score of 0 on the Clinician Reported 
Photonumeric Cellulite Severity Scale (CR-PCSS). The same dimples within a quadrant or 
different dimples within a quadrant may be treated at each session but injections must all be 
within the selected quadrant for all 3 sessions. Each treatment session will be separated by 
approximately 21 days. Day 71 visit (end of treatment/early termination [EOT/ET]) will be 
performed for each subject. After Day 71, the subjects will be observed every 3 months from 
their first exposure to EN3835 up to a maximum of 1 year in each treated quadrant (including 

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both open-label and double-blind treated quadrants, if different quadrants were treated across 
both studies). Durability beyond Day 360 will be assessed in subjects who received active 
treatment in EN3835-201 and showed a composite improvement of at least 1 level on both the 
CR-PCSS and the Patient Reported Photonumeric Cellulite Severity Scale (PR-PCSS). In these 
subjects, the original quadrant treated in EN3835-201 will be assessed until the end of the current 
study, in addition to any treated quadrants occurring in the current study. Assessments of 
durability beyond Day 360 may also include subjects who opted not to receive additional 
treatments in EN3835-202. 
1.2. 
Schedule of Study Assessments 
Table 2 lists the schedule of observation assessments, Table 3 lists the schedule of treatment 
session assessments, Table 4 lists the schedule of long-term durability assessments.  
The schedule of observation assessments is applicable for both observation only and treated 
subjects in current study. For example, if subjects received treatments (ie, re-treatment, 
re-dosing, or a first treatment) in current study may be scheduled for observation assessments up 
to maximum of 1 year for each treated quadrant.  
NOTE: Observation visits (Table 2) in the open-label extension study begin after completion of 
double-blind study (Day 71). Treatment sessions (Table 3), if elected, will begin after study drug 
blind is broken in study EN3835-201while observation visits continue concurrently. Durability 
visits (Table 4) are for the subjects who received active treatment in EN3835-201 and scored an 
improvement of at least 1 level on both the CR-PCSS and the PR-PCSS at the same visit on or 
before Day 71 in the double-blind study EN3835-201. 
 

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a Informed consent for open-label observation assessments and optional treatment election. 
b Four (4) visits at 3-month periods begin 90 days after Day 1 of the double-blind study (EN3835-201) (ie, within 20 days ± 4 days of completion of double-blind 
study). 
c Only the treated quadrant(s) is photographed. For subjects participating in observation-only visits, the quadrant treated in the double-blind study (EN3835-201) 
is photographed; for subjects with open-label treatment (treated with EN3835 in study EN3835-202), the treated quadrant is photographed. 
d Assessment made via viewing digital image photograph. 
e Assessment of treated quadrant(s) only. 
f For subjects treated with active EN3835 in the double-blind study and having a different quadrant treated in the open-label study, refer to Table 4 for continued 
assessments of the double-blind treated quadrant for durability beyond Day 360. NOTE: Subject cellulite assessments must be completed before the 
Investigator cellulite assessments are conducted at each visit.  
NOTE: Subject cellulite assessments must be completed before the Investigator cellulite assessments are conducted at each visit. 
 

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a After the study drug blind is broken in study EN3835-201, eligible subjects may elect to receive EN3835 treatments. 
b Upon completion of treatment, subject will be followed at 3-month intervals as in Table 2; if study terminates early, subject will be followed through Visit 4 
(Day 71). If subject received placebo in the double-blind study (EN3835-201), she may be eligible for a total of 2 courses of treatment (a total of 6 treatment 
sessions) in this study. 
c All 4 quadrants are photographed at screening; at other visits, the selected quadrant only is photographed. 
d Before and after marking the dimples. 
e Before injection. 
f Up to 4 hours before injection; approximately 15 and 30 minutes after injection. Vital signs must be stable before the subject is discharged. 
g Assessment made via photograph (if treatment session, use photograph taken before marking dimples). 
h All 4 quadrants are assessed at the Screening B visit; at other visits, the selected quadrant only is assessed. 
i ,QLWLDO+H[VHO&66DWVFUHHQLQJPXVWEHRQVHOHFWHGTXDGUDQW 
j To qualify for treatment, the selected quadrant must have a score of 3 or 4 (moderate or severe) in both the CR-PCSS and PR-PCSS, and a Hexsel CSS score 
WRTXDOLI\DTXDGUDQWWKDWKDGEHHQSUHYLRXVO\WUHDWHGZLWK(1LQVWXG\(1-201, the quadrant must have CR-PCSS and PR-PCSS scores equal to 
or greater than study EN3835-EDVHOLQHVFRUHVDQGD+H[VHO&66VFRUH 
k Medical history and prior medications will be based on EN3835-201 eCRF; only updates and concomitant medications need to be captured at Screening B visit. 
l Do not conduct if Screening B visit date is within 12 months of obtaining an ECG during the double-blind study (EN3835-201). 
m Do not conduct on subjects eligible and opting-in for a second course of treatment in the current study (EN3835-202) if Screening B visit or Day 1 visit for 
second treatment course is the same day as Day 71 of the first treatment course in this study or previous study EN3835-201. 
ECG=Electrocardiogram; eCRF=Electronic case report form; EFP=Edematous fibrosclerotic panniculopathy; Tx=Treatment 
NOTE: Subject cellulite assessments must be completed before the Investigator cellulite assessments are conducted at each visit. 

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1.3. 
Study Objectives 
1.3.1. 
Primary Objective 
The primary objective of this study is to assess long-term safety of EN3835 0.84 mg at scheduled 
intervals over 1 year (12 months) or more in all subjects with EFP who elect to enroll in this 
open-label trial regardless of their decision to receive treatment (re-treatment or re-dosing) of 
open-label EN3835 or opt to receive no treatment.  
1.3.2. 
Secondary Objectives 
The secondary objectives of this study are: 
x To evaluate safety and immunogenicity of re-treating or re-dosing a subject that had 
previously received treatment with EN3835 
x To evaluate the durability of response to EN3835 in EFP severity over the 12-month 
post initial dosing of EN3835 in subjects previously receiving active treatment in 
study EN3835-201 using the PR-PCSS and the CR-PCSS  
x To evaluate the durability of response to EN3835 in EFP severity beyond 12-month 
post initial dosing of EN3835 in subjects previously receiving active treatment in 
study EN3835-201 using the PR-PCSS and the CR-PCSS 
x To evaluate long-term response to EN3835 in assessments of EFP including subject 
satisfaction, Investigator Global Aesthetic Improvement Scale (I-GAIS), and Subject 
Global Aesthetic Improvement Scale (S-GAIS) 
x To assess cellulite severity assessments in quadrants treated in this study with 
EN3835 
x To evaluate immunogenicity after exposure to EN3835 
1.4. 
Study Medication 
Subjects will be administered a maximum of EN3835 0.84 mg from a total of up to 12 injections. 
Up to 12 injections will be administered at each treatment session to treat the selected quadrant. 
Each of the injections will be administered as three 0.1-mL aliquots (total injection volume per 
injection is 0.3 mL; total injection volume per treatment session is 3.6 mL [12 injections × 
0.3 mL], see Table 5 below). 
Subjects will receive 3 treatment sessions (Day 1, Day 22, and Day 43) separated at least 21 days 
unless the chosen quadrant has no further treatable EFP dimples and the Investigator rates the 
quadrant a score of 0 on the CR-PCSS.  

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Table 5: 
EN3835 Administration 
Dose per 
Each Injectiona 
Injection 
Volume per 
Each Injection 
Maximum 
Number of 
Injections per 
Each Treatment 
Session 
Maximum Dose 
(mg) per Each 
Treatment 
Session 
Maximum 
Injection Volume 
(mL) per Each 
Treatment 
Session 
Maximum 
Cumulative EFP 
Dose 
EN3835 0.07 mg 
0.3 mL 
12 injections  
0.84 mg 
(12 injections  
× 0.07 mg) 
3.6 mL 
(12 injections  
× 0.3 mL) 
2.52 mg 
(3 treatment sessions 
× 0.84 mg) 
a Each injection of EN3835 is 0.3 mL administered as three 0.1-mL aliquots.  
The complete Schedule of Events is provided in Section 1.2 (Table 2, Table 3 and Table 4).  
1.5. 
Randomization and Unblinding 
This study will be conducted as an open-label investigation; no randomization and blinding of 
assigned treatment will occur. 
1.6. 
Interim Analysis 
No interim analysis is planned for this study. 
 
Sample Size Justification 
Approximately 350 subjects that completed the EN3835-201 study will enroll in the current 
study. This sample size should be adequate to determine long term safety and cellulite 
assessments of EN3835.  
2. 
ANALYSIS POPULATIONS AND PHASES 
The following populations will be considered in the statistical analysis of the study: 
x Observation Population: The Observation population includes all subjects rolled over 
from study EN3835-201. The cellulite assessment evaluations and safety analyses on 
data collected during observation phase will be performed using this population. 
x Safety Population: The Safety population will include all subjects who receive at least 
1 dose of EN3835 in the current study. All safety analyses for the treatment phase 
will be performed using this population. For by region summaries, safety population 
is considered within each treatment course. 
x Effectiveness Population: The Effectiveness population includes all safety subjects 
who have a baseline and at least 1 post-baseline assessment on both the CR-PCSS and 
PR-PCSS on the quadrant selected for treatment in the current study. All analysis of 
effectiveness for the treatment phase will be based on this population. For by region 
summaries, effectiveness population is considered within each treatment course. 
x Durability Population: This population is defined as all active responders who have 
both CR-PCSS and PR-PCSS at 180 days or above. The active responders are 
subjects treated with EN3835 with improvements of at least 1 level on each 

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scale (CR-PCSS and PR-PCSS) at Day 71 visit compared to the baseline. Analysis of 
durability of treatment effect will be performed using this population. 
 Durability Population for Double-blind Treated Subjects: This population is 
defined as all subjects in the durability population who showed an improvement 
of at least 1 level on each scale (CR-PCSS and PR-PCSS) at Day 71 visit 
compared to the baseline for the quadrant treated with EN3835 in double-blind 
study EN3835-201. 
 Durability Population for Open-label Treated Subjects: This population is defined 
as all subjects in the durability population who showed an improvement of at least 
1 level on each scale (CR-PCSS and PR-PCSS) at Day 71 visit compared to the 
baseline for the quadrant treated with EN3835 in the open-label study 
EN3835-202 study, who did not have the same quadrant treated with EN3835 in 
double-blind study EN3835-201. For by region summaries, this population is 
considered within each treatment course. 
The following 2 phases will be summarized in the statistical analysis of the study: 
x Observation phase: Observation phase is defined as the time period from Screening A to 
the first treatment date of the same quadrant in study EN3835-202 or the end of study 
EN3835-202 if there is no treatment received for the same quadrant in study 
EN3835-202. Observation phase is defined within each treated quadrant, unless the 
summary is for subject level only and cannot be differentiated by the treated quadrant, 
ie, disposition, adverse event (AE). For subject level summaries, observation phase is 
defined as the time period from Screening A to the first treatment date in study 
EN3835-202 or the end of study EN3835-202 if there is no treatment received in study 
EN3835-202.  
x Treatment phase: Treatment phase is defined as the time period from the first treatment 
date of certain quadrant in study EN3835-202 to the end of study EN3835-202. 
Treatment phase is defined within each treated quadrant, unless the summary is for 
subject level only and cannot be differentiated by the treated quadrant, ie, disposition, 
AE. For subject level summaries, treatment phase is defined as the time period from the 
first treatment date to the end of study EN3835-202.  
3. 
STATISTICAL METHODS AND CONSIDERATIONS 
3.1. 
Descriptive Statistics 
All analysis results will be presented in summary table using appropriate descriptive statistics, 
unless otherwise stated. The statistics include the number (count) and percentage for all 
categorical variables. The denominator will be based on the number of subjects in each column 
group in the summary table, unless otherwise stated. All continuous variables will be 
summarized with observed count, mean, standard deviation, median, minimum, and maximum 
value. 

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3.2. 
Baseline Considerations 
The baselines for all cellulite assessments, including CR-PCSS, PR-PCSS, and Hexsel CSS will 
be the observed values at visit Day 1 before subjects receive EN3835 treatment. If the values at 
Day 1 are missing, the values at Screening will be used for those assessments. For observation 
phase before EN3835 treatment in current study, the baselines will be the values at Day 1 for 
study EN3835-201. The reference values will be the observed scores at Day 71 in study 
EN3835-201 for those assessments. For the potentially clinically importance (PCI) calculation 
for vital sign values, the baseline refers to the latest vital sign assessment values before the first 
treatment in study EN3835-202. 
All baselines for safety measures, ie, vital signs, clinical laboratory parameters, will use the latest 
values before subjects receive the first treatment in study EN3835-202. 
3.3. 
Protocol Deviation Subjects Handling 
A listing of protocol deviations will be provided. Before database lock, the statistical team will 
programmatically check against the pre-specified criteria provided in a separate document, 
ie, Protocol Deviation Checklist, and produce a list of protocol deviations. The data review team 
will review the outputs and the protocol deviation tracker obtained during the study conduct, 
then determine the major/minor category for each deviation. If any data points or subjects are 
excluded from the analysis, they will be documented in the data review meeting minutes and also 
be presented in a data listing. 
3.4. 
Reporting Precision 
Summary statistics will be presented to the following degree of precision, unless otherwise 
specified: 
Statistics 
Degree of Precision 
Mean, Geometric Mean, Median, Quartiles, 
Confidence Limit Boundaries 
One (1) decimal place more than the raw data 
Standard Deviation, Standard Error 
Two (2) decimal places more than the raw data 
Minimum, Maximum 
The same as the raw data 
Percentage 
One (1) decimal place. A percentage of 100% will be 
reported as 100.0. Percentages of zero will be reported 
as 0.0. 
Up to 3 decimal places will be presented. Fractional numeric values will be presented with a zero 
to the left of the decimal point (for example, 0.12 – 0.30). 
4. 
SUBJECT DISPOSITION 
The number of subjects included in each study population will be summarized. The number and 
percentage of subjects completed and discontinued will be presented by observation and 
treatment phase. Reasons for discontinuation as recorded on the eCRF will be summarized 
(number and percentage) and listed for all subjects. 

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5. 
DEMOGRAPHICS AND OTHER BASELINE 
CHARACTERISTICS 
Demographic and baseline characteristics, including age, age group, race, and some other 
baseline values will be summarized for the Safety population and the Effectiveness population 
using appropriate descriptive statistics. Demographic and baseline characteristics will also be 
listed. 
6. 
EFFECTIVENESS ANALYSES 
6.1. 
Cellulite assessments 
x PR-PCSS: 5-level ratings ranging from 0 (none) to 4 (severe). It will be assessed at 
Screening B, Days 22, Day 43, Day 71 and observational visits Day 90, Day 180, 
Day 270, Day 360 and Long-term Durability Visits, ie, Day 450, Day 540, Day 630, 
and Day 720. 
x CR-PCSS: 5-level ratings ranging from 0 (none) to 4 (severe). It will be assessed at 
Screening B, Days 22, Day 43, Day 71 and observational visits Day 90, Day 180, 
Day 270, Day 360 and Long-term Durability Visits, ie, Day 450, Day 540, Day 630, 
and Day 720. 
x Investigator rating of cellulite severity using the total scores from the Hexsel CSS 
scale: scores can range from 0 to 15. It will be assessed at Screening B, Day 71, 
Day 360 and Long-term Durability Visits. 
x I-GAIS: 7-level ratings ranging from 3 (very much improveGWRíYHU\PXFK
worse). This will be assessed at Day 71 and Day 360. 
x S-GAIS: 7-level ratings UDQJLQJIURPYHU\PXFKLPSURYHGWRíYHU\PXFK
worse). This will be assessed at Day 71 and Day 360. 
x Subject satisfaction with cellulite treatment assessment: 5-level ratings ranging from 
+2 (very much satisfied) WRíYHU\PXFKGLVVDWLVILHG. This will be assessed at 
Day 71 and Day 360. 
All cellulite assessments will be done by treated quadrant and overall. For initial treatment 
subjects who have 2 quadrants treated, each quadrant will be evaluated separately. In the 
observation phase, those assessments will be also done corresponding to the treated quadrant. 
6.2. 
Effectiveness Analysis 
6.2.1. 
Composite Endpoints 
The composite endpoints for cellulite severity are the proportions of composite responders 
defined as subjects with an improvement in severity from baseline of at least 2 (or 1) levels of 
severity in the CR-PCSS and an improvement in severity from baseline of at least 2 (or 1) levels 
of severity in the PR-PCSS. 

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These endpoints will be summarized by treated quadrant and overall (buttocks and thighs) and by 
study day using appropriate descriptive statistics. 
6.2.2. 
Other Cellulite Assessment Endpoints 
Other endpoints for treated quadrants in study EN3835-202 include: 
x Change from baseline for PR-PCSS 
x Proportion at each level of improvement in the PR-PCSS: 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels on the PR-PCSS 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 1 level on the PR-PCSS 
x Change from baseline for CR-PCSS 
x Proportion at each level of improvement in the CR-PCSS: 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels on the CR-PCSS (Investigator rated) 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 1 level on the CR-PCSS (Investigator rated) 
x Proportion of responders at each level of the I-GAIS: 
 Proportion of subjects at each level of the I-GAIS ranging from 3 (very much 
LPSURYHGWRíYHU\PXFKZRUVH,WZLOOEHDVVHVVHGDW'D\DQG'D\ 
x Proportion of responders at each level of the S-GAIS: 
 Proportion of subjects at each level of the S-GAIS ranging from 3 (very much 
LPSURYHGWRíYHU\PXFKZRUVH,WZLOOEHDVVHVVHGDW'D\DQG'D\ 
x Proportion of responders at each level of the subject satisfaction with cellulite 
treatment  
x Change in the Hexsel CSS total score from screening visit  
All endpoints will be summarized by treated region (buttock or thigh) and overall and by study 
day using appropriate descriptive statistics, unless specified otherwise (eg, by treatment course). 
6.2.3. 
Observation Endpoints 
Observational endpoints for treated quadrant in study EN3835-201 include: 
x Change from baseline for PR-PCSS 
x Proportions of composite responders defined as subjects with an improvement in 
severity from baseline of at least 2 (or 1) levels of severity in the CR-PCSS and an 
improvement in severity from baseline of at least 2 (or 1) levels of severity in the 
PR-PCSS 

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x Proportion at each level of improvement in the PR-PCSS: 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels on the PR-PCSS 
 Proportion of patient responders defined as subjects with an improvement in 
severity from baseline of at least 1 level on the PR-PCSS 
x Change from baseline for CR-PCSS 
x Proportion at each level of improvement in the CR-PCSS: 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 2 levels on the CR-PCSS (Investigator rated) 
 Proportion of Investigator responders defined as subjects with an improvement in 
severity from baseline of at least 1 level on the CR-PCSS (Investigator rated) 
x Proportion of responders at each level of the subject satisfaction at Day 360 
x Hexsel CSS total score changed from the study EN3835-201 baseline at Day 71 of 
study EN3835-201 and Day 360 or Day 360 Beyond long-term durability visits.  
These endpoints will be summarized by treatment groups assigned in study EN3835-201 and 
treated region (buttock or thigh) and overall and by study day using appropriate descriptive 
statistics. 
6.3. 
Durability of Treatment Effect 
The durability of treatment effect will be accessed based on the longitudinal responses of 
cellulites assessments of CR-PCSS and PR-PCSS. The number and percentage of responders at 
each level (ie, 1 level or 2 levels improvements) for CR-PCSS, PR-PCSS and their combinations 
(ie, composite score, 1 level or 2 levels improvements for both scores) associated with treated 
quadrants will be summarized by study day. The treatment failure is defined as active responders 
whose CR-PCSS and PR-PCSS return to the baseline or worse in an EN3835-treated quadrant 
during a certain follow-up period. The number and percentage will be summarized by study day, 
ie, Day 180, Day 360, Day 540, and Day 720. 
Since there are 2 groups of responders, one group was subjects who were treated with EN3835 in 
the double-blind EN3835-201 study and followed up in the current EN3835-202 study up to 
2 years. The durability analysis described above for this group will be based on the durability 
population in double-blind treated subjects. The other group will be subjects who will be treated 
with EN3835 and then followed up to 1 year in the current EN3835-202 study. The durability 
analysis for this group will be based on the durability population in open-label treated subjects. 
 
SAFETY ANALYSES 
The following variables are safety endpoints. 
x AEs 

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well as the number of subjects that didn’t receive 12 injections for all treatment sessions will be 
tabulated by treatment region. Subjects with protocol deviation will be listed. In addition, 
subjects who did not receive 3 treatment sessions and subjects who didn’t receive 12 injections at 
a treatment session will also be listed separately. 
 
Adverse Events 
Treatment-emergent adverse events (TEAEs) is defined as any AE with onset date on or after the 
treatment start date in each treatment course in study EN3835-202. TEAEs are defined within 
each treatment course in study EN3835-202. AEs with missing or partial onset date and cannot 
be determined in which treatment course it occurred with its onset and end dates will be 
considered as TEAEs in treatment course 1. AEs with missing or partial onset date and cannot be 
determined in which treatment session it occurred with its onset and end dates will be considered 
as earliest treatment course and earliest treatment session possible. 
Treatment-related adverse events are TEAEs with a relationship to study medication of possible, 
probable, or missing. 
AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), 
Version 19.0.  
Overall AE summaries for observation phase as well as overall TEAE summaries for treatment 
phase will be tabulated. Descriptive statistics (the number and percentage) for subjects reporting 
AEs, TEAEs, and Adverse Events of Special Interest (AESI) will be tabulated by system organ 
class (SOC) and preferred term (PT); by SOC, PT, and severity; and by SOC, PT, severity and 
relationship to study drug. TEAE will also be summarized by SOC, PT, and treatment course. 
The duration of treatment related AE descriptive statistics will be summarized within each PT 
under each SOC. The TEAE tables will be sorted by SOC and PT in decreasing frequency of the 
number of subjects in the overall column. 
If there are more than 1 AE coded to the same SOC or PT for the same subject under a certain 
column in the summary table, the subject will be counted only once for that SOC or PT under 
that column. If there are more than 1 AE coded to the same PT for the same subject, the subject 
will be counted only once for that PT using the most severe and most related occurrence for the 
summarization by severity and by relationship to the study drug. If there are more than 1 AE 
coded to the same PT, the longest AE will be used for that PT for the duration descriptive 
statistics. 
Serious adverse events (SAEs) and AEs leading to premature discontinuation of study drug will 
be summarized. Listings will be presented for subjects with AEs, SAEs, AESI, AEs leading to 
discontinuation, and subjects who die (if any). 
 
Vital Signs 
Descriptive statistics for vital signs (body weight, body mass index [BMI], systolic and diastolic 
blood pressure, pulse rate, respiratory rate, and temperature) and their changes from baseline at 
each visit and at the end of treatment visit will be presented.  
Vital sign values are potentially clinically important (PCI) if they meet both the observed value 
criteria and the change from baseline criteria. The criteria for PCI vital sign values are detailed 

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in Appendix A. The baseline in PCI rules refers to the latest vital sign assessment values before 
the first treatment in study EN3835-202. 
A listing of all subjects with PCI vital signs will also be provided. 
 
Clinical Laboratory Parameters 
Table 6 lists all testing parameters for clinical laboratory in this study. 
Descriptive statistics for clinical laboratory values in International System of Units (SI) and 
changes from baseline will be presented for each clinical laboratory parameter.  
Table 6: 
Clinical Laboratory Parameters 
Hematology 
Clinical Chemistry 
Urinalysis 
Hematocrit 
Hemoglobin 
Red blood cell count 
Red blood cell morphology 
White blood cell count 
Neutrophils 
Lymphocytes 
Monocytes 
Basophils 
Eosinophils 
Platelets 
Blood urea nitrogen 
Creatinine 
Total bilirubin 
Alanine aminotransferase (ALT) 
Aspartate aminotransferase (AST) 
Alkaline phosphatase 
Sodium 
Potassium 
Calcium 
Chloride 
Phosphate 
Serum bicarbonate 
Uric acid 
Total cholesterol 
Total protein 
Glucose 
Triglycerides 
Albumin 
Specific gravity 
Ketones 
pH 
Protein 
Blood 
Glucose 
 
The number and percentage of subjects with PCI post-baseline clinical laboratory values will be 
tabulated. The criteria for PCI laboratory values are detailed in Appendix A. A listing of all 
subjects with PCI laboratory values will also be provided. 
 
Immunogenicity Analyses 
Immunogenicity variables include anti-AUX-I/anti-AUX-II binding antibody results. Binding 
antibody levels will be determined from samples collected on Day 1 Day 71 and Day 360.  
Descriptive statistics (percent of positive measurements and average antibody level) will be 
presented for anti-AUX-I and anti-AUX-II antibody levels at each time point by region treated, 
treatment course and overall. Average antibody levels will be summarized on logarithmically 
transposed titer values. 
In addition, a subset of these immunogenicity samples will be analyzed for neutralizing 
antibodies by calculating the frequency count of the positive samples and the negative samples 
and the percentage of samples in each category. 

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8. 
HANDLING OF MISSING DATA 
8.1. 
Handling Missing Data on Efficacy Variable 
Subjects may have missing data on observational visits at Day 90, Day 180, Day 270, Day 360, 
and some long-term durability visits, Day 450, Day 540, Day 630 and Day 720. The backward 
imputation method will be utilized for the values of CR-PCSS and PR-PCSS. For instance, if a 
subject missed Day 90, Day 180 visits, but he/she has values at Day 270. Then the values at 
Day 270 will be imputed for the values at Day 180, and Day 90 visits.  
No imputation will be applied to other cellulite assessments 
8.2. 
Handling Partial or Missing Dates on AE, CM, and MH 
Partial or complete missing date for AEs, concomitant medication (CM), and medical history 
(MH) will not be imputed. TEAE and prior and concomitant medication will be determined by 
using available date information. If available date information cannot determine, refer to 
section 7.1 for prior and concomitant medication, section 7.4 for TEAE. 
9. 
CHANGES TO PLANNED ANALYSES 
The EN3835-202 protocol [Section 17.2] defines the 4 different cohorts and states all efficacy 
and safety analyses will be done within the classified cohort. In this statistical analysis plan, the 
efficacy and safety analyses are summarized by different phases (observation phase, treatment 
phase, long-term durability visits) and populations (observation population, safety population, 
effectiveness population, and durability population) instead. 
The EN3835-202 protocol [Section 17.2.1] defines the observational population as including all 
subjects rolled over from the EN3835-201 study who do not receive any treatment in the current 
study. This population is renamed to “Observation Population” for this document, as described in 
section 2. It is defined as: The observation population includes all subjects rolled over from the 
EN3835-201 study. The cellulite assessment evaluations and safety analyses for the data 
collected from Screening A to Day 360 will be based on this population. This change will allow 
the data observed during observation phase to be summarized under this new population.  

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APPENDIX A. PCI CRITERIA 
Laboratory Values 
Test 
Low 
High 
Platelets (109/L) 
100 
 
Hemoglobin (g/L) 
100 
 
Hematocrit 
0.3 
0.6 
ALT 
--- 
3 × ULN 
AST 
--- 
3 × ULN 
Creatinine (μmol/L) 
--- 
 
BUN (mmol/L) 
--- 
 
Vital Signs 
Test 
Low 
High 
Systolic Blood Pressure 
PP+JDQGGHFUHDVHPP+J
from baseline 
PP+JDQGLQFUHDVHPP+J
from baseline 
Diastolic Blood Pressure 
PP+JDQGGHFUHDVHPP+J
from baseline 
PP+JDQGLQFUHDVHPP+J
from baseline 
Pulse Rate 
ESPDQGGHFUHDVHESPIURP
baseline 
ESPDQGLQFUHDVHESPIURP
baseline 
Respiratory Rate 
EUSPDQGGHFUHDVHEUSPIURP
baseline 
EUSPDQGLQFUHDVHEUSPIURP
baseline 
Temperature 
--- 
°&DQGLQFUHDVH°C from 
baseline