A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-2)
Phase: PHASE3
Conditions: Glabellar Frown Lines
Sponsor: Revance Therapeutics, Inc.

 
 
 
 
 
TITLE 
A Phase 3, Randomized, Double-Blind, Placebo 
Controlled, Multi-Center Trial to Evaluate the Efficacy 
and Safety of DaxibotulinumtoxinA for Injection to Treat 
Moderate to Severe Glabellar Lines (SAKURA-2) 
PROTOCOL NUMBER 
1620302 
SPONSOR 
Revance Therapeutics, Inc. 
7555 Gateway Boulevard 
Newark, CA  94560 
Tel.: 510.742.3400 
Fax: 510.662.4903 
DOCUMENT TYPE 
Amended Protocol 
VERSION  
Amendment 1, 07 November 2016 
 
 
The trial will be conducted in compliance with the obligations as detailed in this protocol, 
and all applicable regulations and guidelines (e.g., International Conference on 
Harmonisation [ICH] Good Clinical Practices [GCP] guidelines). 
 
 
 
CONFIDENTIALITY STATEMENT 
The information contained in this document, particularly unpublished data, is 
provided to you in confidence as an Investigator, potential Investigator, or consultant 
for review by you, your staff, and an applicable Institutional Review Board or 
Independent Ethics Committee.  The information is only to be used by you in 
connection with authorized clinical studies of the investigational product(s) described 
in the protocol.  You will not disclose any of the information to others without 
written authorization, except to the extent necessary to obtain informed consent from 
those persons to whom the investigational product(s) may be administered. 

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INVESTIGATOR’S AGREEMENT  
I have carefully read the protocol entitled: “A Phase 3, Randomized, Double-Blind, 
Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of 
DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines” and,  
I will provide copies of the protocol, any subsequent protocol amendments and access to 
all information provided by the Sponsor to the trial personnel under my supervision. I 
will discuss this material with them to ensure that they are fully informed about the 
investigational drug and the trial protocol. 
I agree to conduct this clinical trial according to the attached protocol, in compliance with 
all applicable laws and regulations, and in accordance with the ethical principles 
stipulated in the Declaration of Helsinki.  
 
 
Investigator Signature 
 
 
 
 
 
 
Printed Name 
 
Date 
Institution Name 
 
 
Address 
 
 
City, State  Postal Code, Country 
 
Phone Number 
 

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PROTOCOL SYNOPSIS 
Name of Sponsor/Company: 
Revance Therapeutics, Inc. 
Name of Finished Product: 
DaxibotulinumtoxinA for Injection  
Name of Active Ingredient: 
daxibotulinumtoxinA 
Title of Trial:  
A Phase 3, Randomized, Double-Blind, Placebo Controlled, Multi-Center Trial to Evaluate the Efficacy 
and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines (SAKURA-
2) 
Trial Center(s):  
Up to 15 centers in the United States (US) and Canada 
Number of Subjects Planned: 
Approximately 300 subjects will be enrolled 
Trial Period:  
Up to 38 weeks, including 2 weeks for screening 
Phase of Development: 
3 
Objective: 
To evaluate the efficacy and safety of a single treatment of DaxibotulinumtoxinA for Injection for the 
treatment of moderate to severe glabellar lines compared to placebo.  
Design and Methodology: 
This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial. Approximately 
300 adult subjects with moderate to severe glabellar lines will be enrolled. Subjects will be randomly 
assigned in a 2:1 ratio to DaxibotulinumtoxinA for Injection 40 U or placebo.  
All subjects will be followed for at least 24 weeks post-treatment for efficacy and safety assessments. If 
both Patient Frown Wrinkle Severity (PFWS) and Investigator Global Assessment Frown Wrinkle 
Severity (IGA-FWS) scores at maximum frown, return to baseline by the Week 24 visit or at a visit 
between Weeks 24 and 36, the visit at which that score is recorded will be the Final Evaluation Visit for 
the subject. 
After the Final Evaluation Visit, all qualified subjects will have the option to enroll into an open-label, 
trial to evaluate the long-term safety of repeat use of DaxibotulinumtoxinA for Injection for the treatment 
of moderate to severe glabellar lines. 
The Investigator, trial center staff, subjects, and Sponsor will remain blinded to study treatment 
throughout the trial. Only the statistician responsible for the randomization codes will be unblinded to the 
treatment assignments. 
 
Treatment Group 
Test Article and Dose 
No. of Subjects 
Treatment 1 
DaxibotulinumtoxinA for 
Injection 40 U 
200 
Treatment 2 
Placebo 
100 
 
Trial Visits: 
Screening (–Week 2), Treatment (Day 0), Follow-up at Weeks 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36.  
Safety Evaluations:  
 Clinical laboratory tests (hematology, chemistry, prothrombin time [PT], urinalysis)  
  
  

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Name of Sponsor/Company: 
Revance Therapeutics, Inc. 
Name of Finished Product: 
DaxibotulinumtoxinA for Injection  
Name of Active Ingredient: 
daxibotulinumtoxinA 
 Injection Site Evaluation 
 
 
 12-lead ECG 
 Concomitant medications 
 Collection of AEs 
 
 Vital Signs  
 Physical Examination 
Efficacy Evaluations:  
 Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) 
 Patient Frown Wrinkle Severity (PFWS) 
 Investigator and Patient Global Aesthetic Improvement Scale (GAIS) 
Other Evaluations: 
 Photographs of treatment area 
 Subject Global Satisfaction with Treatment Questionnaire 
 Subject diary to capture subject severity ratings for the first 2 weeks following treatment 
  
 Facial Age Self Evaluation (FASE)  
Diagnosis and Main Abbreviated Eligibility Criteria:  
Outpatient, male or non-pregnant, non-nursing females, 18–75 years of age, and in good general health 
with moderate (2) or severe (3) glabellar lines during maximum frown based on the IGA-FWS and 
PFWS. (Refer to Protocol Section 3.4 Eligibility Criteria). 
Test Article, Dose and Mode of Administration: 
DaxibotulinumtoxinA for Injection, 40 U, intramuscular injection, 0.5 mL 
Control, Dose and Mode of Administration:  
Placebo: DaxibotulinumtoxinA placebo, intramuscular injection, 0.5 mL 
Statistical Analyses: 
Primary Efficacy Endpoints   
Primary clinical efficacy will be assessed by a blinded evaluator who will grade the severity of the 
subject’s glabellar lines at maximum frown using the IGA-FWS. Also the subject will grade the severity 
of their glabellar lines at maximum frown using the PFWS. A responder will be defined as a subject who 
achieves a score of 0 or 1 (none or mild) and an improvement of at least two points from the baseline 
score, on both the IGA-FWS and PFWS scales concurrently at Week 4. 
The Proportion of Responders will be compared between daxibotulinumtoxinA and placebo at Week 4 
using the Cochran–Mantel–Haenszel (CMH) test stratified by trial center. 
 
 
 
 

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Name of Sponsor/Company: 
Revance Therapeutics, Inc. 
Name of Finished Product: 
DaxibotulinumtoxinA for Injection  
Name of Active Ingredient: 
daxibotulinumtoxinA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Sample Size and Power Considerations 
Estimates of treatment efficacy taken from trial RT002-CL002 show that a sample size of 200 and 100 for 
DaxibotulinumtoxinA 40 U for injection and placebo, respectively, 
 
 
 
 
 
 
. 

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation 
Definition 
AE 
adverse event 
ATC 
Anatomical Therapeutic Chemical 
BoNTA 
botulinum neurotoxin type A 
BP 
blood pressure 
CI 
confidence interval 
CMH 
Cochran–Mantel–Haenszel 
CRF 
case report form 
CRO 
contract research organization 
CS 
clinically significant 
ECG 
Electrocardiogram 
FASE 
Facial Age Self Evaluation  
FDA 
Food and Drug Administration 
 
  
GAIS 
Global Aesthetic Improvement Scale 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
GLSS 
Glabellar Line Severity Score 
HHS 
U.S. Department of Health and Human Services 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IGA-FWS 
Investigator Global Assessment Frown Wrinkle Severity 
IRB 
Institutional Review Board 
ITT 
intent to treat 
kDa 
Kilodalton 
Kg 
Kilogram 
KM 
Kaplan-Meier 
MedDRA 
Medical Dictionary for Regulatory Activities 
mL 
milliliter 
MRC 
Medical Research Council 
NCS 
not clinically significant 
PFWS 
Patient Frown Wrinkle Severity 
PP 
per protocol 
PT 
prothrombin time 
Revance 
Revance Therapeutics, Inc. 
 

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Abbreviation 
Definition 
RR 
respiration rate 
RT001 
DaxibotulinumtoxinA Topical Gel 
RT002 
DaxibotulinumtoxinA for Injection 
RTP004 
Novel excipient, inactive ingredient 
SAE 
serious adverse event 
SAS 
Statistical Analysis System 
SOP 
standard operating procedure 
TdP 
Torsade de Pointe 
U 
units 
UPT 
urine pregnancy test 
WHO 
World Health Organization 
WOCBP 
woman of child bearing potential 
 
 
 

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TABLE OF CONTENTS 
SIGNATURE PAGE ..........................................................................................................2 
INVESTIGATOR’S AGREEMENT ................................................................................3 
PROTOCOL SYNOPSIS ..................................................................................................4 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ................................7 
TABLE OF CONTENTS ..................................................................................................9 
LIST OF TABLES ...........................................................................................................12 
LIST OF FIGURES .........................................................................................................12 
1 BACKGROUND ........................................................................................................13 
 
 
 
 
 
 
 
 
2 TRIAL OBJECTIVE .................................................................................................16 
3 TRIAL DESIGN.........................................................................................................17 
3.1 
Overall Trial Design ...........................................................................................17 
3.1.1 Duration of Trial .....................................................................................17 
3.1.2 Control ....................................................................................................17 
3.1.3 Dosage/Dose Regimen ............................................................................17 
3.1.4 Visit Schedule .........................................................................................17 
 
 
3.3 
Trial Population ..................................................................................................18 
3.4 
Eligibility Criteria ...............................................................................................18 
3.4.1 Informed Consent and Authorization to Release Health Information ....18 
3.4.2 Inclusion Criteria ....................................................................................19 
3.4.3 Exclusion Criteria ...................................................................................20 
4 TRIAL PROCEDURES ............................................................................................23 
4.1 
Subject Entry Procedures ....................................................................................23 
4.1.1 Pregnancy................................................................................................23 
4.2 
Schedule of Visits and Procedures......................................................................24 
4.2.1 Screening Visit ........................................................................................24 
4.2.2 Treatment Visit (Day 0) ..........................................................................25 
4.2.3 Week 1 Follow-Up Visit .........................................................................27 
4.2.4 Follow-up Visits .....................................................................................28 
4.2.5 Final Evaluation Visit or Early Discontinuation.....................................29 

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4.2.6 Discontinuation/Withdrawal Procedures ................................................31 
4.3 
Variation from Scheduled Visit Days .................................................................32 
4.4 
Schedule of Visits and Procedures......................................................................32 
4.5 
Safety Assessments .............................................................................................32 
4.5.1 Clinical Laboratory Data ........................................................................32 
4.5.2 Pregnancy Testing...................................................................................33 
4.5.3 Vital Signs...............................................................................................33 
4.5.4 Physical Examination .............................................................................33 
4.5.5 12-Lead ECG ..........................................................................................34 
4.5.6 Injection Site Evaluation .........................................................................34 
 
 
 
 
 
 
4.5.10 Adverse Events .......................................................................................37 
 
4.6 
Efficacy Assessments .........................................................................................39 
4.6.1 Primary and Secondary Efficacy Assessments .......................................39 
4.6.2 Additional Assessments ..........................................................................41 
 
 
4.7 
Screen Failures ....................................................................................................42 
4.8 
Protocol Deviations.............................................................................................42 
5 
 
5.1 
Concomitant Medications ...................................................................................43 
 
 
6 EVALUATION OF ADVERSE EVENTS ...............................................................45 
6.1 
Definitions ..........................................................................................................45 
6.1.1 Clinical Laboratory Changes ..................................................................46 
6.1.2 Investigational Product Causality and Severity ......................................46 
6.2 
Reporting Adverse Events ..................................................................................47 
6.3 
Serious Adverse Events ......................................................................................47 
6.4 
Procedure for Accessing the Randomization Code ............................................47 
6.5 
Follow-up of Adverse Events .............................................................................48 
6.5.1 Follow-Up of Non-Serious Adverse Events ...........................................48 
6.5.2 Follow-Up of Post Trial Serious Adverse Events ...................................48 
7 STATISTICAL ANALYSIS .....................................................................................49 
7.1 
General Considerations .......................................................................................49 
7.2 
Analysis Populations...........................................................................................49 

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7.3 
Trial Endpoints ...................................................................................................49 
7.4 
Summaries of Trial Conduct and Treatment Group Comparability ...................51 
7.5 
Efficacy Analyses ...............................................................................................51 
7.5.1 Primary Efficacy Endpoint .....................................................................52 
 
 
 
 
 
 
7.5.5 Handling Missing Data and Other Considerations .................................56 
7.5.6 Sensitivity and Subgroup Analyses ........................................................56 
7.6 
Safety Analyses...................................................................................................57 
7.6.1 Adverse Events .......................................................................................57 
7.6.2 Laboratory Tests .....................................................................................57 
7.6.3 Vital Signs AND PHYSICAL EXAMINATION ...................................58 
7.6.4 Injection Site Evaluation .........................................................................58 
 
 
 
 
 
 
7.6.8 Concomitant Therapies/Medications ......................................................58 
7.6.9 ECG ........................................................................................................58 
7.7 
Sample Size and Power Considerations..............................................................59 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9 RECORDS MANAGEMENT ...................................................................................63 
9.1 
Data Collection ...................................................................................................63 
9.2 
File Management at the Trial Center ..................................................................65 
9.3 
Records Retention at the Trial Center.................................................................65 
10 MONITORING, COMPLIANCE, AND QUALITY ..............................................66 
 
11 ETHICS AND RESPONSIBILITY ..........................................................................68 
 
 

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LIST OF TABLES 
Table 1: Description of Treatment Groups ........................................................................17 
Table 2: Allowed Variation from Scheduled Visit Days ...................................................32 
Table 3: Clinical Laboratory Tests ....................................................................................32 
Table 4: Injection Site Evaluation......................................................................................34 
 
 
 
 
Table 9: Patient Frown Wrinkle Severity (PFWS) ............................................................39 
Table 10: Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) ............40 
Table 11: Global Aesthetic Improvement Scale ................................................................41 
Table 12: Prohibited Medications and Treatments ............................................................43 
 
LIST OF FIGURES 
Figure 1: Injection Sites .....................................................................................................74 

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1 
BACKGROUND 
The safety and effectiveness of botulinum toxin type A to act on the neuromuscular 
junction and relieve muscle spasm and its clinical effects such as strabismus, pain, and 
facial wrinkles has been well established for over 20 years (Scott, 1981; Carruthers, 
1992; Spencer, 2002). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 
TRIAL OBJECTIVE 
To evaluate the efficacy and safety of a single treatment of DaxibotulinumtoxinA for 
Injection for the treatment of moderate to severe glabellar lines compared to placebo.  
 

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3 
TRIAL DESIGN 
3.1 
OVERALL TRIAL DESIGN 
This phase 3, double blind, placebo-controlled, multi-center trial is designed to evaluate 
the efficacy and safety of a single intramuscular treatment of DaxibotulinumtoxinA for 
Injection for the temporary improvement in the appearance of glabellar lines in adults 
compared to a placebo. Approximately 300 adult subjects with moderate to severe 
glabellar lines will be enrolled. 
3.1.1 DURATION OF TRIAL 
The duration is up to 38 weeks on trial, including a screening period of up to two weeks 
followed by a single treatment and a follow-up period of up to 36 weeks post-treatment. 
All subjects will be followed for at least 24 weeks post-treatment.  
3.1.2 CONTROL 
Placebo to match DaxibotulinumtoxinA for Injection  
3.1.3 DOSAGE/DOSE REGIMEN 
Subjects will be randomized to receive one of the two treatments shown in Table 1. 
Table 1: Description of Treatment Groups 
Test Article and Dose 
No. of Subjects 
DaxibotulinumtoxinA for Injection 40 U 
200 
Placebo  
100 
 
All treatments will be intramuscular injections administered by a trained physician. 
Subjects will receive a single treatment of 
 
 
. The Investigators, trial center 
staff, subjects, and Revance will remain blinded to the treatment group assignments. Only 
the statistician responsible for the randomization scheme will be unblinded to the 
treatment assignments.  
3.1.4 VISIT SCHEDULE 
A screening visit will be conducted up to two weeks prior to randomization, and subjects 
will be treated with investigational product on Day 0. Following treatment, subjects will 
complete a paper diary for the initial 2-week period to capture their assessment of the 
appearance of the lines. Post-treatment on-site follow-up visits will occur at Weeks 1, 2, 

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4, 8, 12, 16, 20, 24, 28, 32, and 36 or when the Patient and Investigator’s Global 
Assessment Frown Wrinkle Severity (PFWS and IGA-FWS) scores return to baseline. 
All subjects should be followed up for a minimum of 24 weeks post treatment. 
 
 
 
 
 
 
 
 
 
3.3 
TRIAL POPULATION 
Approximately 300 female or male subjects, 18–75 years of age, in good general health, 
with moderate or severe glabellar lines will be enrolled. 
3.4 
ELIGIBILITY CRITERIA 
3.4.1 INFORMED CONSENT AND AUTHORIZATION TO RELEASE HEALTH 
INFORMATION 
Written informed consent will be obtained from all subjects before any study-related 
procedures (including any screening procedures) are performed. The Investigator may 
discuss the trial and the possibility for entry with a potential subject without first 
obtaining consent. However, a subject wishing to participate must give written informed 
consent prior to any study-related procedures being conducted, including those performed 
solely for the purpose of determining eligibility for study participation, and including 
withdrawal from current medication (if required prior to study entry). The Investigator 
has both the ethical and legal responsibility to ensure that each subject being considered 
for inclusion in this trial has been given a full explanation of the procedures and 
expectations for study participation. 
The site-specific informed consent must be forwarded to Revance for approval prior to 
submission to an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) 
that is registered with the US Department of Health and Human Services (HHS) or 
applicable health authority. Each subject will sign the consent form that has been 
approved by the same IRB/IEC that was responsible for protocol approval. Each 
informed consent document must adhere to the ethical principles stated in the Declaration 

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of Helsinki and will include the elements required by FDA regulations in 21 CFR Part 50, 
as well as the elements required by the International Conference on Harmonisation (ICH) 
Good Clinical Practice (GCP) guideline, and applicable federal and local regulatory 
requirements. The consent form must also include a statement that Revance, their 
designees, and auditing regulatory agencies will have direct access to the subject’s 
records and medical history for study related purposes. 
Once the appropriate essential information has been provided to the subject and fully 
explained by the Investigator (or a qualified designee) and it is felt that the subject 
understands the implications and risks of participating in the trial, the IRB/IEC approved 
consent document shall be signed and dated by both the subject and the person obtaining 
consent (Investigator or designee), and by any other parties required by the IRB/IEC or 
other regulatory authorities. The subject will be given a copy of the signed informed 
consent document with the original kept on file by the Investigator. All of the above 
activities must be completed before any study related procedures are conducted 
(including any screening study procedures).  
3.4.2 INCLUSION CRITERIA 
All subjects must meet the following inclusion criteria: 
1. Provide written informed consent including authorization to release health 
information 
2. Outpatient, male or non-pregnant, non-nursing females, 18–75 years of age, and 
in good general health  
3. Moderate (2) or severe (3) glabellar lines during maximum frown based on the 
Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale 
4. Moderate (2) or severe (3) glabellar lines during maximum frown based on the 
Patient Frown Wrinkle Severity (PFWS) scale 
5. Willing to refrain from receiving facial fillers, laser treatments, use of any product 
that affects skin remodeling, or a product that may cause an active dermal 
response in the treatment area from screening through the end of the trial 
6. Female subjects of childbearing potential must have a negative urine pregnancy 
test result at the Screening Visit and at the Treatment Visit, prior to 
investigational product administration, and practice an effective method of 
contraception throughout the trial (section 4.1.1) 
7. Able to understand the requirements of the trial and sign informed consent 
including authorization to release health information 
8. Willing and able to follow all trial procedures, attend all scheduled visits, and 
successfully complete the trial 

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3.4.3 EXCLUSION CRITERIA 
Subjects will not be enrolled if they meet any of the following exclusion criteria: 
1. Any neurological condition that may place the subject at increased risk with 
exposure to botulinum toxin type A, including peripheral motor neuropathic 
diseases such as amyotrophic lateral sclerosis and motor neuropathy, and 
neuromuscular junctional disorders such as Lambert-Eaton syndrome and 
myasthenia gravis 
2. Muscle weakness or paralysis in the area receiving study treatment; or history of 
facial nerve palsy (e.g., Bell’s Palsy) 
3. Active skin disease, infections or inflammation at the injection sites 
4. Significant facial asymmetry, eyelid ptosis or history of same, significant brow 
ptosis or history of same, excessive dermatochalasis, deep dermal scarring, thick 
sebaceous skin, or inability of investigator to completely or almost completely 
eliminate glabellar lines by physically spreading medial brows apart while at rest 
5. A score of 2 or higher in any category of the Regional House-Brackman Facial 
Nerve Grading System at screening 
6. Previous treatment with botulinum toxin type A in the face within 6 months prior 
to screening 
7. Plan to receive botulinum toxin type A anywhere in the face through the duration 
of the study 
8. Treatment with greater than 200 U botulinum toxin type A anywhere else in the 
body outside of the face within the last 3 months prior to screening and through 
the end of trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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No additional exclusions may be applied by the investigator in order to ensure that the 
trial population will be representative of all eligible subjects. 
Deviation from any entry criterion excludes a subject from enrollment into the trial. 
 

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4 
TRIAL PROCEDURES 
4.1 
SUBJECT ENTRY PROCEDURES 
Subject informed consent must be obtained prior to conducting screening procedures. 
At the screening visit, procedures including vital signs, physical examination, collection 
of samples for hematology, chemistry, prothrombin time (PT), 
 
urinalysis, urine pregnancy test (UPT) for WOCBP, collection of concomitant medication 
and medical history information, examination of the treatment area, PFWS, and IGA-
FWS must be completed. Results from clinical laboratory tests and centrally-read ECG 
must be obtained and reviewed by the Investigator. Any WOCBP having a positive 
pregnancy test pre-treatment will not be treated.  
After the required screening procedures are completed and study eligibility is confirmed 
as defined by the eligibility criteria in Sections 3.4.2 and 3.4.3, the subject will be 
randomized to treatment and the assigned blinded investigational product will be 
prepared by the blinded dose preparer and administered by the Investigator. 
4.1.1 PREGNANCY 
WOCBP must use an effective method of birth control during the course of the trial, such 
as the oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, 
intrauterine device, tubal ligation, barrier method used WITH an additional form of 
contraception (e.g., sponge, spermicide or condom), abstinence, no heterosexual 
intercourse, or has a vasectomized partner. A female is considered to be of childbearing 
potential UNLESS she is post-menopausal (no menses for 12 consecutive months) or 
without a uterus and/or both ovaries. 
Before enrolling WOCBP in this clinical trial, Investigators must review guidelines about 
study participation for WOCBP. The topics should generally include: 
 Informed consent document 
 Pregnancy prevention information 
 Risks to unborn child(ren) 
 Any drug interactions with hormonal contraceptives 
 Contraceptives in current use 
 Guidelines for the follow-up of a reported pregnancy 
Prior to study enrollment, WOCBP must be advised of the importance of avoiding 
pregnancy during participation in this clinical trial and the potential risk factors for an 

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unintentional pregnancy. The subject must sign the informed consent document stating 
that the above-mentioned risk factors and the consequences were discussed with her. 
During the trial, all WOCBP should be instructed to contact the Investigator immediately 
(within 24 hours) if they suspect they might be pregnant (e.g., missed or late menstrual 
cycle). The Investigator must immediately notify Revance or designated Contract 
Research Organization (CRO) of any female subject who becomes pregnant any time 
during study participation, record the information on the Pregnancy Notification Form 
and send the form to the CRO. The site will be asked to follow-up with the subject 
periodically during the pregnancy for ongoing health and safety information through 
term, as applicable. Subjects will remain on the trial. 
4.2 
SCHEDULE OF VISITS AND PROCEDURES 
It is recommended that trial visits be scheduled at approximately the same time of day 
throughout the trial. 
The IGA-FWS and Investigator GAIS should be performed by the same evaluator 
throughout the trial whenever possible. If it is not possible to use the same evaluator to 
follow the subject throughout the trial, two evaluators should examine the subject 
together and discuss findings for at least one prior visit. A schedule of study assessments 
is provided in Appendix J. 
4.2.1 SCREENING VISIT 
The Screening Visit must take place within 14 days prior to investigational product 
administration at Day 0 (Treatment Visit). The following procedures must be performed 
and recorded at this visit: 
1. Review trial procedures and information regarding the trial and obtain written 
informed consent 
2. Review eligibility criteria 
3. Obtain medical/surgical history, including prior toxin use, and demographic 
information, including Fitzpatrick skin type 
4. Conduct patient education: Discuss the potential effect of DaxibotulinumtoxinA 
for Injection treatment, explain the PFWS measurement and the categories of the 
severity assessment scales, and instruct the subjects to consider depth of lines for 
severity of their glabellar lines. Use the provided Patient Education Brochure 
5. Measure and record vital signs (body temperature, respiratory rate, sitting radial 
pulse, and sitting systolic and diastolic blood pressure) 
 
 
7. Obtain 12-lead ECG 

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8. Collect blood samples for clinical safety laboratory tests (hematology, chemistry, 
and PT)  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
The screening visit clinical laboratory test results, UPT and ECG report must be reviewed 
and signed by the Investigator; any abnormal results must be determined to be not 
clinically significant by the Investigator prior to randomization. 
4.2.2 TREATMENT VISIT (DAY 0) 
The Treatment Visit must be performed within 14 days of the Screening Visit. The 
following procedures must be performed and recorded:  
Prior to Investigational Product Administration 
1. Review eligibility criteria and confirm that all screening visit procedures have 
been completed, results reviewed, and recorded 
2. Update medical/surgical history 
3. Conduct patient education: Discuss the potential effect of DaxibotulinumtoxinA 
for Injection treatment, explain the PFWS measurement and the categories of the 
severity assessment scales, and instruct the subjects to consider depth of lines for 
severity of their glabellar lines. Use the provided Patient Education Brochure 

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4. Measure and record vital signs (body temperature, respiratory rate, sitting radial 
pulse, and sitting systolic and diastolic blood pressure) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16. Once the Investigator has confirmed subject eligibility, enroll the subject 
Investigational Product Preparation 
The assigned, blinded investigational product will be prepared by the blinded, trained 
dose preparer according to trial-specific instructions. The prepared investigational 
product will be provided in a syringe to the Investigator for administration. 
Investigational Product Administration 
Investigational product will be administered by the Investigator to injection site in the 
designated treatment area (Appendix A) while the subject is in a sitting position.  
1. Wear protective gloves for investigational product administration 
2. Pull subject’s hair away from the treatment area (forehead) 
3. Wipe all injection sites with alcohol 

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4. Inject a dose of 
 
 
 
 
 
After Investigational Product Administration 
1. 
 obtain 
vital signs (body temperature, respiratory rate, sitting radial pulse, and sitting 
systolic and diastolic blood pressures) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2.3 WEEK 1 FOLLOW-UP VISIT  
At Week 1, following the first treatment, the subject will return to the office for a health 
status check, concomitant therapy/medication check, and a query about AEs that may 
have occurred.  
The following procedures must be performed and recorded:  
1. Query subject about concomitant therapy/medication 
2. Query subject about any AEs 
 
 
 
 
 

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7. Conduct patient education: discuss the potential effect of DaxibotulinumtoxinA 
for Injection treatment, explain the PFWS measurement and the categories of the 
severity assessment scales, and instruct the subjects to consider depth of lines for 
severity of their glabellar lines. Use the provided Patient Education Brochure 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.2.4 FOLLOW-UP VISITS  
At Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32 the following procedures must be performed and 
recorded: 
 
 
2. Conduct patient education: discuss the potential effect of DaxibotulinumtoxinA 
for Injection treatment, explain the PFWS measurement and the categories of the 
severity assessment scales, and instruct the subjects to consider depth of lines for 
severity of their glabellar lines. Use the provided Patient Education Brochure 
3. At Week 2 only, measure and record vital signs (body temperature, respiratory 
rate, sitting radial pulse, and sitting systolic and diastolic blood pressure) 
 
 
  
 
 
 
 

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7. At Week 4 only, obtain 12-lead ECG 
 
 
 
 
  
 
 
 
12. Provide 
 and Facial Age Self 
Evaluation (FASE) (Section 4.6.2.4) questionnaires to subject for completion 
 
 
 
 
 
 
 
 
 
 
 
 
 
19. Assess AEs 
 
 
 
 
 
 
 
4.2.5 FINAL EVALUATION VISIT OR EARLY DISCONTINUATION  
The following procedures must be performed and recorded at the Final Evaluation Visit 
for each subject. Following treatment, subjects will be followed for safety until at least 
Week 24 and up to Week 36 with monthly visits until both IGA-FWS and PFWS scores 
have returned to baseline. The subject will then have a Final Evaluation Visit.  

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1. Conduct patient education: Discuss the potential effect of DaxibotulinumtoxinA 
for Injection treatment, explain the PFWS measurement and the categories of the 
severity assessment scales, and instruct the subjects to consider depth of lines for 
severity of their glabellar lines. Use the provided Patient Education Brochure 
2. Measure and record vital signs (body temperature, respiratory rate, sitting radial 
pulse, and sitting systolic and diastolic blood pressure) 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10. Provide 
 and Facial Age Self 
Evaluation (FASE) (section 4.6.2.4) questionnaires to subject for completion 
 
 
 
 
 
 
 
 
 
 
 
 
16. Assess AEs 
 
 
 
 
 
 

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If there are no safety concerns, the subject’s participation in the trial is complete at this 
visit.  
After the Final Evaluation Visit, all qualified subjects will have the option to enroll into 
an open-label, trial to evaluate the long-term safety of repeat use of DaxibotulinumtoxinA 
for Injection for the treatment of moderate to severe glabellar lines. 
4.2.6 DISCONTINUATION/WITHDRAWAL PROCEDURES 
A subject may voluntarily withdraw from study participation at any time. If the subject 
withdraws consent and discontinues from the trial, the Investigator will attempt to 
determine the reason for discontinuation and record the reason in the subject’s trial 
records and on the case report form (CRF). If a subject withdraws consent because of an 
AE, that AE should be indicated as the reason for withdrawal. In the event of early 
discontinuation, (i.e., prior to the Final Evaluation) and whenever possible, the subject 
should be asked to return to the trial center to complete the assessments specified in the 
Final Evaluation Visit. Subjects who withdraw from the trial will not be replaced. 
If at any time during the trial, the Investigator determines that it is not in the best interest 
of the subject to continue, the subject will be discontinued from participation. The 
Investigator can discontinue a subject from study participation at any time if medically 
necessary or if the subject has failed to follow trial procedures or to keep follow-up 
appointments. Appropriate documentation in the subject’s trial record and CRF regarding 
the reason for discontinuation must be completed. Prior to discontinuing a subject from 
study participation, the Investigator will discuss his/her intentions with the Medical 
Monitor or designee. 
All subjects who fail to return to the trial center for the required follow-up visits will be 
contacted by phone to determine the reason(s) why the subject failed to return for the 
necessary visit or elected to discontinue from the trial. If a subject is unreachable by 
telephone after a minimum of two documented attempts (one attempt on two different 
days), a registered letter will be sent requesting that contact be made with the 
Investigator.  
Revance has the right to terminate or to stop the trial at any time. Should this be 
necessary, both Revance and the Investigator will ensure that proper study 
discontinuation procedures are completed. 

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4.3 
VARIATION FROM SCHEDULED VISIT DAYS 
To allow for scheduling flexibility, limited variation will be permitted from the specified 
time of each visit (Table 2). 
Table 2: Allowed Variation from Scheduled Visit Days 
Scheduled Visit 
Allowed Variation 
Week 1  
+ 2 days 
Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, and 36 
+/- 3 days 
 
4.4 
SCHEDULE OF VISITS AND PROCEDURES 
A schedule of visits and procedures is provided in Appendix J. 
4.5 
SAFETY ASSESSMENTS 
4.5.1 CLINICAL LABORATORY DATA 
As outlined in Table 3, non-fasting samples for hematology, chemistry, PT and urinalysis 
will be collected at Screening, Week 4, and at the Final Evaluation Visit. 
 
 Blood and 
urine will be collected using applicable safety precautions and will be processed 
according to the central clinical laboratory’s instructions. Urinalysis will be evaluated at 
the trial center using supplies provided by the sponsor. 
Table 3: Clinical Laboratory Tests 
Serum Chemistry 
Hematology 
Urinalysis 
Additional Tests 
Glucose 
Total bilirubin 
Alanine aminotransferase 
Aspartate 
aminotransferase 
Alkaline phosphatase 
Blood urea nitrogen 
Hemoglobin 
Hematocrit 
Leukocyte Count 
(total) 
Leukocyte Count 
(differential) 
Red Blood Cell 
Count 
Platelet Count 
Specific gravity 
pH 
Glucose 
Protein 
Blood 
Bilirubin 
Ketones 
Prothrombin time (PT) 
(Screening, Week 4 and 
Final Evaluation only) 
Urine Pregnancy 
(WOCBP only)* 
 
 
 
 
 
 
*If positive at timepoints after study treatment, confirm by serum pregnancy test 
 
It is the Investigator’s responsibility to review the results of all laboratory tests as they 
become available. For each laboratory test result outside the reference range, the 
Investigator must ascertain if the abnormal lab result is a clinically significant result for 
that individual subject. Likewise, if laboratory tests are taken at follow-up visits, the 

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Investigator must ascertain if this is an abnormal and clinically significant change 
pretreatment for that individual subject. The Investigator may repeat the laboratory test or 
request additional tests to verify the results of the original laboratory test. The 
Investigator must sign and date all written laboratory results (e.g., urinalysis, hematology, 
chemistry, PT, and pregnancy tests) and note Not Clinically Significant (NCS) or 
Clinically Significant (CS) for each out of range laboratory value. If a laboratory value is 
determined to be a clinically significant result for that subject, this may be considered an 
AE. Refer to Section 6.1.1 for further information. 
 
 
 
 
4.5.2 PREGNANCY TESTING 
All WOCBP will have a UPT at the Screening Visit, Treatment Visit pre-treatment, and 
Final Evaluation Visit or Early Discontinuation, if applicable. If any result is positive 
prior to treatment, the subject will not be allowed to participate. The results of the UPTs 
for WOCBP will be evaluated at the trial center. Refer to Section 4.1.1 for further 
information. 
4.5.3 VITAL SIGNS 
Vital signs (i.e., body temperature, respiration rate, sitting radial pulse rate, and sitting 
systolic and diastolic blood pressures) will be obtained at the Screening and Treatment 
Visit (pre- and post-treatment), Week 2, Final Evaluation or Early Discontinuation Visits 
and at any visit where signs or symptoms of botulinum toxicity is reported. 
4.5.4 PHYSICAL EXAMINATION 
A physical examination, in addition to vital signs, 
 
 general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, 
heart, lungs, abdomen, lymph nodes, and extremities will be conducted at Screening, 
Week 2 and Final Evaluation or Early Discontinuation Visits. Significant physical 
examination findings that are present prior to investigational product administration are 
to be included on the Medical History page. 
Significant physical examination findings which meet the definition of an adverse event 
will be recorded on the adverse event page post-treatment. 

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4.5.5 12-LEAD ECG 
At Screening and Week 4, a single standard supine 12-Lead ECG will be obtained after a 
subject has rested quietly for at least 10 minutes using equipment provided from the 
central reader. The ECG data will be submitted to a central reader for measurement.  
4.5.6 INJECTION SITE EVALUATION 
Injection sites will be evaluated at the Screening Visit, Treatment Visit pre- and 
post-treatment (to determine if there is an immediate reaction to the investigational 
product), Follow-up Visits, and Final Evaluation Visit or Early Discontinuation Visit, if 
applicable. The assessment will be done as a global evaluation of the 5 injection sites 
(Table 4).  
Table 4: Injection Site Evaluation 
Assessment Descriptor 
Present? 
 
Yes 
No 
Erythema 
 
 
Edema 
 
 
Burning or Stinging (sensation as described by subject) 
 
 
Itching (sensation as described by subject) 
 
 
Bruising 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4.5.10 ADVERSE EVENTS 
Adverse Events (AEs) will be graded as mild, moderate, or severe as defined in 
Section 6.1.2 of this protocol. 
AEs will be evaluated at the Treatment Visit post-treatment, Follow-up Visits, and Final 
Evaluation Visit or Early Discontinuation Visit, if applicable. Section 6 outlines the 
procedures for recording and reporting AEs. 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4.6 
EFFICACY ASSESSMENTS 
4.6.1 PRIMARY AND SECONDARY EFFICACY ASSESSMENTS 
Efficacy assessments will include investigator assessment of glabellar line severity and 
glabellar line improvement, subject assessment of glabellar line severity and 
improvement. Efficacy assessments will be conducted with the subject in a sitting 
position. In order to have consistent eye positioning during the assessment, the 
investigator should ask the subject to focus on a fixed point in the examination room. The 
assessment should be conducted in a room with good overhead lighting or natural light 
from a window (but not direct sunlight). 
4.6.1.1 Patient Frown Wrinkle Severity (PFWS) 
At each clinic visit as designated in the Schedule of Trial Assessments (Appendix J), the 
subject will assess the visual appearance (at maximum frown and at rest after maximum 
frown) of the glabellar lines using the following 4 point scale for subject’s assessment of 
Patient Frown Wrinkle Severity (Appendix B, Table 9). The assessment form will be 
provided directly to the subject to complete while reviewing the glabellar treatment area 
using a handheld mirror as outlined in Appendix B. Subjects with contact lenses should 
view their glabellar lines with contacts. Subjects wearing glasses should be advised to 
view their glabellar lines without glasses if possible. If glasses are needed for the subject 
to see their glabellar lines, then glasses can be worn for the assessment. The subject 
assessment must be completed before the Investigator completes the IGA-FWS 
assessment. 
Table 9: Patient Frown Wrinkle Severity 
(PFWS) 
Rating Score  
Frown Wrinkle 
Severity  
Description  
0 
None 
No wrinkles 
1 
Mild 
Very shallow wrinkles 
2 
Moderate 
Moderate wrinkles 
3 
Severe 
Deep wrinkles 
 
 
 

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4.6.1.2 Investigator Global Assessment Frown Wrinkle Severity 
At each clinic visit as designated in the Schedule of Trial Assessments (Appendix J), the 
Investigator will assess the visual appearance (at maximum frown and at rest after 
maximum frown) of the glabellar lines using the IGA-FWS with the following 4 point 
scale (Table 10). 
Table 10: Investigator Global Assessment Frown Wrinkle Severity 
(IGA-FWS) 
Rating Score 
Frown Wrinkle Severity  
Description  
0 
None 
No wrinkles 
1 
Mild 
Very shallow wrinkles 
2 
Moderate 
Moderate wrinkles 
3 
Severe 
Deep and furrowed wrinkles 
 
 
 
 
 
 
 
 
4.6.1.3 Global Aesthetic Improvement Scale 
The Investigator and subject will assess the visual appearance (at maximum frown and at 
rest after maximum frown) of the glabellar line improvement from the baseline condition 
using the following 7 point severity Global Aesthetic Improvement Scale (GAIS, 
Table 11). Assessments will be made at the visits as designated in the Schedule of Trial 
Assessments (Appendix J).  
The Patient GAIS assessment form (Appendix E) will be provided directly to the subject 
to complete while reviewing the glabellar treatment area (at maximum frown and at rest 
after maximum frown) using the supplied handheld mirror as outlined in Appendix E. 
Subjects with contact lenses should view their glabellar lines with contacts. Subjects 
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If glasses are needed for the subject to see their glabellar lines, then glasses can be worn 
for the assessment. The subject assessment must be completed before the Investigator 
completes the IGA-FWS assessment. 
Table 11: Global Aesthetic Improvement Scale 
Rating Score 
Wrinkle Improvement  
-3 
Very Much Worse 
-2 
Much Worse 
-1 
Worse 
0 
No Change 
1 
Improved 
2 
Much Improved 
3 
Very Much Improved 
 
4.6.2 ADDITIONAL ASSESSMENTS  
4.6.2.1 Subject Diary 
At Day 0, subjects will be provided a paper diary Appendix D for the initial 2-week post 
treatment period to capture their assessment of the appearance of the lines at maximum 
frown using the 4 point severity scale. Subject’s assessment of glabellar line severity is 
described above in Section 4.6.1.1, Table 9. Instructions on how to complete the diary 
will be provided with the diary to the subjects. 
4.6.2.2 Subject Global Satisfaction with Treatment Questionnaire 
The subject will be asked to provide a rating of their satisfaction with the treatment 
results at the Week 4 visit. Following the subject’s completion of the Patient GAIS, the 
subject will be given a questionnaire to rate their satisfaction with the treatment results. 
Subjects will be asked how satisfied or dissatisfied they are with how the treated area of 
the face looks (Appendix F).  
 
 
 
 
 
 
 

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4.6.2.4 Facial Age Self Evaluation (FASE) 
At each clinic visit designated in the Schedule of Trial Assessments (Appendix J), the 
subject will be asked to rate their perceived age on a FASE questionnaire (Appendix H). 
Following the subject’s completion of the Patient GAIS, the subject will be given a 
questionnaire to rate their perception of how old they think they look following the 
treatment. Subjects will be asked how old they think they look post treatment in order to 
evaluate the psychological impact. 
 
 
 
 
 
 
 
 
 
 
 
  
4.7 
SCREEN FAILURES 
A screen failure subject will be a person from whom informed consent is obtained and is 
documented in writing (i.e., subject signs an informed consent form), but who does not 
meet the study eligibility requirements.  
4.8 
PROTOCOL DEVIATIONS 
This trial will be conducted as described in this protocol, except for an emergency 
situation in which the protection, safety, and well-being of the subject requires immediate 
intervention, based on the judgment of the Investigator (or a responsible, appropriately 
trained professional designated by the Investigator). In the event of a significant deviation 
from the protocol due to an emergency, accident, or mistake, the Investigator or designee 
must contact Revance at the earliest possible time by telephone. This will allow an early 
joint decision regarding the subject’s continuation in the trial. This decision will be 
documented by the Investigator and the Sponsor.   

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5 
PROHIBITED THERAPIES AND MEDICATIONS 
5.1 
CONCOMITANT MEDICATIONS 
Concomitant medications are any prescription or over-the-counter preparations used by 
subjects during participation in the trial. Use of concomitant medications will be recorded 
on the Concomitant Medications case report form (CRF) beginning at the Screening Visit 
until the Final Evaluation Visit. The dose and dosing regimen of all prescription and 
non-prescription therapies and medications, including herbs, vitamins, or other nutritional 
supplements administered will be documented. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
  
 
 
  
 
 
 
  
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
  
 
 
  
  
 
 

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6 
EVALUATION OF ADVERSE EVENTS 
6.1 
DEFINITIONS 
For this protocol, an adverse event (AE) is any untoward medical occurrence (e.g., sign, 
symptom, disease, syndrome, intercurrent illness, clinically significant abnormal 
laboratory finding, injury or accident) that emerges or worsens following administration 
of investigational product and until the end of trial participation that may not necessarily 
have a causal relationship to the administration of the investigational product. An AE can 
therefore be any unfavorable and/or unintended sign (including a clinically significant 
abnormal laboratory result), symptom, or disease temporally associated with the use of an 
investigational product, whether or not considered related to the investigational product. 
A treatment-emergent AE is one that occurs after any period of exposure to treatment. 
Pre-existing conditions, which increase in frequency or severity or a change in nature as a 
consequence of an investigational product use will also be considered an adverse event. 
An unexpected AE is an adverse reaction, the nature or severity of which is not consistent 
with the applicable product information (e.g., Investigator’s Brochure for an unapproved 
investigational product or package insert/summary of product characteristics for an 
approved product). 
Any clinically significant change in the study safety evaluations, (e.g., vital signs, 
injection site evaluation, 
 
 post-treatment must be reported as an AE. 
A serious adverse event (SAE) is any untoward medical occurrence that results in any of 
the following outcomes: 
 Death 
 Life-threatening, (i.e., the subject was, in the opinion of the Investigator, at 
immediate risk of death from the event as it occurred. It does not apply to an AE 
that hypothetically might have caused death if it were more severe) 
 Persistent or significant disability/incapacity or substantial disruption of the 
subject’s ability to carry out normal life functions 
 Requires in-patient hospitalization or prolongs hospitalization (i.e., a prolonged 
hospitalization beyond the expected length of stay; hospitalizations for elective 
medical/surgical procedures, scheduled treatments, or routine check-ups are not 
SAEs by this criterion) 
 Congenital anomaly/birth defect (i.e., an adverse outcome in a child or fetus of a 
subject exposed to the molecule or investigational product before conception or 
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 Does not meet any of the above serious criteria but based upon appropriate 
medical judgement may jeopardize the subject or may require medical or surgical 
intervention to prevent one of the outcomes listed above (i.e., is a significant or 
important medical event) 
6.1.1 CLINICAL LABORATORY CHANGES 
It is the Investigator’s responsibility to review the results of all laboratory tests as they 
become available. For each laboratory test result outside the reference range, the 
Investigator must ascertain if the abnormal lab result is a clinically significant result for 
that individual subject. This determination, however, does not necessarily need to be 
made the first time an abnormal value is observed; the Investigator may repeat the 
laboratory test or request additional tests to verify the results of the original laboratory 
test. If this laboratory value is determined to be a clinically significant result for that 
subject, this may be considered an AE to be assessed according to severity.  
The Investigator must sign and date all written laboratory reports (e.g., urinalysis, 
hematology, chemistry, PT, and pregnancy tests) and note Not Clinically Significant 
(NCS) or Clinically Significant (CS) for each out of range laboratory value. 
6.1.2 INVESTIGATIONAL PRODUCT CAUSALITY AND SEVERITY  
Relationship of an AE to investigational product will be assessed as follows: 
 Definite: There is a clinically plausible time sequence between the onset of 
the AE and the administration of investigational product; when the event 
responds to withdrawal of investigational product and/or recurs with re-
administration of investigational product 
 Probable: There is a clinically plausible time sequence between the onset of 
the AE and the administration of investigational product; the AE is unlikely 
to be caused by the concurrent/underlying illness, other drugs or procedures 
 Possible: There may or may not be a clinically plausible time sequence 
between the onset of the AE and the administration of investigational product 
and a cause cannot be ruled out 
 Unrelated: There is not a temporal or causal relationship to investigational 
product administration 
The Investigator is responsible for evaluating all AEs and determining the severity of the 
event. Severity will be categorized as mild, moderate or severe according to the following 
definitions: 
 Mild : Event may be noticeable to subject; does not influence daily activities; 
usually does not require intervention 

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 Moderate : Event may be of sufficient severity to make subject uncomfortable; 
performance of daily activities may be influenced; intervention may be needed  
 Severe: Event may cause severe discomfort; usually interferes with daily 
activities; subject may not be able to continue in the trial; treatment or other 
intervention usually needed  
6.2 
REPORTING ADVERSE EVENTS 
The Investigator will assess subjects post-treatment and at each subsequent trial visit for 
the occurrence of AEs. In order to avoid bias in eliciting AEs, subjects should be asked 
the following non leading question: “How have you felt since your last visit?” All AEs 
(serious and non-serious) reported by the subject must be recorded on the source 
documents and CRFs.  
In addition, an Investigator must report an SAE to Revance within 24 hours of their 
awareness of the event according to the procedure outlined below. All fatal or life-
threatening SAEs should be telephoned to Revance or the authorized representative as 
soon as the investigator learns of the event. 
6.3 
SERIOUS ADVERSE EVENTS 
An Investigator must report an SAE to Revance or the designated CRO’s authorized 
representative within 24 hours of their awareness of the event: 
 Complete and return an SAE Form with all information known to date; including 
the investigator’s assessment of causality. 
 If the event is fatal or life-threatening, telephone Revance or the authorized 
representative as soon as the investigator learns of the event. 
 Obtain and maintain all pertinent medical records (discharge summary, autopsy 
report, etc.) and medical judgments of medical personnel who assisted in subject’s 
treatment and follow-up. 
 Provide follow-up information to Revance or the authorized representative. 
Regulatory authorities, IRBs/IEC, and Investigators will be notified of SAEs in 
accordance with applicable regulations and requirements (e.g., GCPs, ICH Guidelines, 
national regulations and local requirements). 
6.4 
PROCEDURE FOR ACCESSING THE RANDOMIZATION CODE 
All subjects will receive DaxibotulinumtoxinA for Injection or placebo. The investigators 
and trial center staff do not have access to the randomization code. Unblinding 
randomization codes are maintained by the unblinded statistician in a locked location. 

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In case of a serious adverse event where knowledge of the subject’s treatment is required 
for the subject’s clinical care and safety, the identity of the treatment administered may 
be requested. The Investigator must contact Revance by telephone with an explanation of 
the need for obtaining the subject’s study treatment information. Documentation of 
accessing the randomization code should be recorded in the subject’s medical record with 
the date and time the randomization code was accessed, and the names of the personnel 
involved. 
6.5 
FOLLOW-UP OF ADVERSE EVENTS  
6.5.1 FOLLOW-UP OF NON-SERIOUS ADVERSE EVENTS 
Non-serious AEs that are identified during the last scheduled trial visit (or early 
discontinuation, if applicable) must be recorded on the AE CRF as ongoing. 
Any clinically significant abnormal test results, e.g., laboratory findings, at the final 
assessment should be followed to resolution or until determined by the Investigator to be 
stabilized. Repeat tests may be indicated to establish this. 
If a subject has any clinically significant, trial-related abnormalities at the end of the trial, 
the Medical Monitor should be notified and every effort made by the Investigator to 
arrange follow up evaluations at appropriate intervals to document the course of the 
abnormalities. 
6.5.2 FOLLOW-UP OF POST TRIAL SERIOUS ADVERSE EVENTS 
SAEs that are identified on the last scheduled contact (or early discontinuation, if 
applicable) must be recorded on the AE CRF page and reported to the CRO and Revance 
according to the reporting procedures outlined in Section 6.3. This may include 
unresolved previously reported SAEs, or new SAEs. The Investigator should follow these 
SAEs until the events are resolved, or the subject is lost to follow-up. The Investigator 
should continue to report any significant follow-up information to the Medical Monitor, 
Revance and the IRB/IEC up to the point the event has been resolved. Resolution means 
the subject has returned to the baseline state of health, or the Investigator does not expect 
any further improvement or worsening of the subject’s condition. 
Any new SAEs reported by the subject to the Investigator that occur after the last 
scheduled contact and are determined by the Investigator to be reasonably associated with 
the administration of investigational product should be reported to Revance and the 
IRB/IEC. 

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7 
STATISTICAL ANALYSIS 
7.1 
GENERAL CONSIDERATIONS 
The analysis of data from the trial will be performed when all subjects have completed 
the trial or discontinued prematurely, and all data are in the database and have been 
cleaned and verified. All statistical programming will be performed using statistical 
analysis system (SAS) version 9.4 or higher.   
A Statistical Analysis Plan, describing all statistical analyses, will be provided as a 
separate document prior to database lock and unblinding of the study treatments. 
7.2 
ANALYSIS POPULATIONS 
All subjects who are randomized and receive treatment will be included in the Intent-to-
Treat (ITT) population. The summaries will be by treatment as randomized.   
All subjects who are randomized, receive treatment, and have provided at least one post-
treatment safety assessment will be included in the safety population.  The summaries 
will be by treatment actually received. 
The Per-Protocol (PP) population will include subjects from the ITT population who 
complete the 4-week evaluation without a major protocol violation. 
 
 
 
 
 
 
 
 
 
 
 
  
 
7.3 
TRIAL ENDPOINTS 
Unless specified otherwise, all endpoints associated with IGA-FWS, PFWS, GAIS, or 
Subject’s Diary, henceforth will be based on assessments at maximum frown. 
Primary Efficacy Endpoint: 
The primary efficacy endpoint of the trial is the proportion of responders with the 
response defined as 
 Achieving a score of 0 or 1 (none or mild) and an improvement of at least two 
points from baseline on both IGA-FWS and PFWS scales concurrently at Week 4 

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Henceforth in the document, the response defined above in the primary efficacy endpoint 
will be abbreviated as “2-point composite response.” The subjects who achieve the 
2-point composite response will be abbreviated as “2-point composite responders.” 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Safety Endpoints: 
 Frequency, severity and relationship to study drug of treatment-emergent adverse 
events during the first four weeks post treatment and the overall study duration 
 Frequency, severity and relationship to study drug of treatment-emergent serious 
adverse events during the first four weeks post treatment and the overall study 
duration 
7.4 
SUMMARIES OF TRIAL CONDUCT AND TREATMENT GROUP 
COMPARABILITY 
The number of subjects randomized will be tabulated by trial center and treatment group. 
Subject disposition (the number of subjects randomized, treated, and completing each key 
trial visits) will be tabulated by treatment group. Premature study discontinuation and 
reasons for discontinuation will be summarized. Eligibility criteria deviations and other 
major protocol violations will be summarized. 
Demographic and baseline characteristics will be summarized for all randomized subjects 
by treatment groups. 
7.5 
EFFICACY ANALYSES 
Unless specified otherwise, the main method of handling missing efficacy data will be 
 
 

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. See Section 7.5.5 for details on methods of handling 
missing data. 
 
 
 
 
 
 
. 
Descriptive statistics will be provided for all efficacy variables at all timepoints by 
treatment group. The point estimate of the treatment difference and 95% confidence 
interval (CI) of the difference (or 90% CI when the comparisons are 1-sided) will be 
generated.   
 
 
 
7.5.1 PRIMARY EFFICACY ENDPOINT 
Primary clinical efficacy will be assessed by the blinded evaluator who will grade the 
severity of the subject’s glabellar lines at maximum frown using the IGA-FWS and the 
subject who will grade the severity of their glabellar lines at maximum frown using the 
PFWS. A response is defined as achieving a score of 0 or 1 (none or mild) and an 
improvement of at least two points from the baseline, on both the IGA-FWS and PFWS 
scales concurrently at the time point of evaluation. With both IGA-FWS and PFWS using 
a 4-point scale and the target population having a score of 2 or 3 (moderate or severe) at 
baseline, achieving an improvement of at least two points is inclusive in the status of 
achieving a score of 0 or 1 (none or mild). Henceforth, the response defined here will be 
abbreviated as “2-point composite response.”    
The proportion of subjects who have a 2-point composite response at Week 4 will be 
compared between daxibotulinumtoxinA and placebo using the Cochran–Mantel–
Haenszel (CMH) test stratified by trial center using a two-sided test with a Type I error 
rate of 0.05.  

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7.5.5 HANDLING MISSING DATA AND OTHER CONSIDERATIONS 
Missing Data 
 
 
 
 
 
 For endpoints that are a composite and/or derived from study assessments, 
imputation of missing data will be performed on the original assessments first.  
No imputations will be utilized for the PP analyses. 
As needed, a model-based multiple imputation approach may be explored to assess the 
impact of different imputation methods on the trial outcomes. 
Pooling Data 
Most of the efficacy endpoints are analyzed with trial center as a stratification factor. The 
trial is intended to be conducted in a manner such that a minimum of 5 ITT subjects in 
each treatment group will be enrolled at each trial center/site. In the event that there are 
too few subjects in a treatment arm at a single site, this site will be combined with 
another to achieve the desired minimum sample size per arm. 
7.5.6 SENSITIVITY AND SUBGROUP ANALYSES 
The robustness of main analysis results for the primary and secondary endpoints will be 
evaluated via sensitivity analyses on the per-protocol population and on data with missing 
values imputed using different approaches, such as no imputation (observed data only) or 
when necessary, multiple imputation.   
Statistical tests will be conducted to identify if there are extreme trial centers that could 
affect the interpretation of common statistical and clinical conclusions. A CMH test of the 
primary efficacy endpoint will be conducted with factors of treatment group stratified by 
trial center. 
 
 
  
 
 
  

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7.6 
SAFETY ANALYSES 
7.6.1 ADVERSE EVENTS 
Safety summaries and analyses will be performed on the safety population. Descriptive 
statistics will be presented to summarize the safety data. 
All AEs will be recorded and classified on the basis of MedDRA terminology. 
Treatment-emergent AEs are those AEs with an onset on or after the date and time of 
study treatment. All treatment-emergent AEs will be summarized by treatment group, 
system organ class, preferred term, severity, relationship, and seriousness.  
Comparisons between treatment groups will be made by tabulating the frequency of 
subjects with one or more treatment-emergent AEs (classified into MedDRA terms) from 
baseline (post-treatment) to Week 4 as well as from baseline (post-treatment) through the 
duration of the trial. 
Serious adverse events (SAEs) will be listed by subject. SAEs will be summarized by 
treatment group, severity, and relationship to study treatment. Each subject will be 
counted only once within a system organ class or a preferred term using the event with 
the greatest relationship and greatest severity. 
All information pertaining to AEs noted during the trial will be listed by subject, detailing 
the verbatim description given by the Investigator, preferred term, system organ class, 
start date, stop date, severity, action taken regarding study drug, corrective treatment, 
outcome, and drug relatedness. The event onset will also be shown relative (in number of 
days) to the date of first study treatment administration. In addition, a list of subjects who 
prematurely discontinue from the trial due to adverse events will also be provided. 
7.6.2 LABORATORY TESTS 
Laboratory test results will be summarized with descriptive statistics for each treatment 
group at Screening and Final Evaluation Visit. Change from Screening to Final 
Evaluation Visit also will be summarized for continuous test results. 
Shift tables will be presented to summarize laboratory test results at Screening and Final 
Evaluation Visit. Normal ranges established by the central laboratory will be used to 

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determine shifts. A listing of all out-of-range laboratory test results at any evaluation will 
also be provided. Determination of clinical significance for all out-of-range laboratory 
values will be made by each investigator and included in the listing. In addition, a listing 
of all clinically significant laboratory test results will be provided. 
 
 
UPTs will be summarized for all treated subjects in the category of WOCBP by treatment 
group and presented in the data listings. 
7.6.3 VITAL SIGNS AND PHYSICAL EXAMINATION 
Vital signs and abnormal findings from the physical examination will be summarized 
with descriptive statistics for each treatment group by visit. 
7.6.4 INJECTION SITE EVALUATION 
Outcomes of the injection site evaluations will be tabulated by visit. 
 
 
  
 
 
 
 
  
 
 
 
7.6.8 CONCOMITANT THERAPIES/MEDICATIONS 
Concomitant therapies/medications used at Screening and at each trial visit will be coded 
using the World Health Organization (WHO) drug dictionary and summarized by 
treatment group, Anatomical Therapeutic Chemical (ATC) second level term, and 
preferred name for the Safety population. 
7.6.9 ECG 
The results of the ECG data will be tabulated by visit.  

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7.7 
SAMPLE SIZE AND POWER CONSIDERATIONS 
Estimates of treatment efficacy taken from trial RT002-CL002 show that a sample size of 
200 and 100 for DaxibotulinumtoxinA 40 U for injection and placebo, respectively, 
 
 
 
 
 
 
 
 

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9 
RECORDS MANAGEMENT 
9.1 
DATA COLLECTION 
For this trial, all protocol-specified data will be recorded in the source documents, and 
data will be entered on the CRFs from the source documents. In addition to signature 
confirmation that a subject meets the study eligibility criteria, upon each subject’s 
completion of the trial, the Investigator will sign a statement indicating that all pages of 
the subject’s case report have been reviewed. Signature stamps and “per signatures” are 
not acceptable.  
It is Revance’s policy that the trial data be verifiable with the source data that necessitates 
access to all original recordings, laboratory reports, and other records for each subject. 
The Investigator must therefore agree to allow access to subjects’ records, and source 
data must be made available for all trial data. Subjects (or their legal representatives) 
must also allow access to their medical records. Subjects will be informed of the 
importance of increased record access and permission granted by signature on the 
informed consent document prior to Screening. 
Checks will be performed to ensure the quality, consistency, and completeness of the 
data. Instances of missing or un-interpretable data will be resolved with the Investigator 
or Study Coordinator. Data queries will be sent to the trial center. Site personnel will be 
responsible for providing resolutions to the data queries and for correcting the CRFs, as 
appropriate. All unused Revance source documents and binders must be returned to 
Revance upon completion of the trial. 
The Investigator must keep written or electronic source documents for every subject 
participating in the clinical trial. The subject file that identifies the study in which the 
subject is participating must include the subject’s available demographic and medical 
information including:  
 Name 
 Contact information 
 Date of birth 
 Sex 
 Medical history 
 Concomitant diseases 
 Concomitant therapies/medication 
 Study visit dates 
 Performed examinations, evaluations, and clinical findings 

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 Investigational product administration 
 AEs, SAEs, or pregnancy (as applicable) 
Additionally, any other documents with source data, especially original printouts of data 
that were generated by technical equipment must be included in the subject’s source 
document (e.g., laboratory value listings). All these documents must have at least the 
subject’s initials, trial number, and the date of the evaluation.  
The data recorded during the course of the trial will be documented in the CRF and/or the 
trial-specific forms. Before or at study termination, all data must be forwarded to 
Revance. The data will then be recorded, evaluated, and stored in anonymous form in 
accordance with data-protection regulations. 
Subjects will authorize the use of their protected health information during the informed 
consent process in accordance with the applicable privacy requirements. Subjects who 
deny permission to use and disclose protected health information will not be eligible to 
participate in the trial. The Investigator will ensure that the trial documents forwarded to 
Revance, and any other documents, contain no mention of subject names. 
Any amendments and corrections necessary will be undertaken in both the source 
documents and CRFs (as appropriate) and countersigned by the Investigator, or 
documented designee, stating the date of the amendment/correction. Errors must remain 
legible and may not be deleted with correction aids. The Investigator must state his/her 
reason for the correction of any data. In the case of missing data/remarks, the entry 
spaces provided in the CRF should be cancelled out so as to avoid unnecessary follow-up 
inquiries. 
Regulatory authorities, the IRB/IEC and/or the Revance’s Quality Assurance group (or 
designee) may request access to all source documents, CRFs, and other trial 
documentation for on-site audit or inspection. The Investigator must guarantee direct 
access to these documents. CRFs will be kept by Revance or an authorized designee in a 
secured area. Clinical data will be recorded in a computer format for subsequent 
statistical analyses. Data files will be stored on electronic media with a final master data 
file kept by Revance after descriptive and statistical analyses and reports have been 
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9.2 
FILE MANAGEMENT AT THE TRIAL CENTER 
It is the responsibility of the Investigator to ensure that the trial center file is maintained 
in accordance with ICH Guidance for Industry E6 Good Clinical Practice: Consolidated 
Guidance, Section 8 – Essential Documents for the Conduct of a Clinical Trial. 
9.3 
RECORDS RETENTION AT THE TRIAL CENTER 
It is a Revance requirement that all Investigators participating in clinical studies maintain 
detailed clinical data for one of the following periods: 
 Country-specific requirements, or 
 A period of at least 2 years following the last approval of a marketing application 
approved by a Regulatory Authority in an ICH region or until there are no 
pending or contemplated marketing applications in an ICH region, or, 
 A period of two years after Revance notifies the Investigator that the data will not 
be submitted for review by any Regulatory Authority  
The Investigator must not dispose of any records or essential documents relevant to this 
trial without either (1) written permission from Revance, or (2) providing an opportunity 
for Revance to collect such records. The Investigator shall take responsibility for 
maintaining adequate and accurate electronic or hard copy source documents of all 
observations and data generated during this trial. Such documentation is subject to 
inspection by Revance and relevant regulatory agencies. If the Investigator withdraws 
from the trial (e.g., relocation, retirement) all trial-related records should be transferred to 
a mutually agreed upon designee. Notice of such transfer will be provided to Revance in 
writing.  
 

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10 MONITORING, COMPLIANCE, AND QUALITY 
All aspects of the trial will be monitored by Revance or authorized representatives of 
Revance according to Good Clinical Practices (GCP) and Standard Operating Procedures 
(SOPs) for compliance with applicable government regulations, (i.e., Informed Consent 
Regulations and Institutional Review Board regulations). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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11 ETHICS AND RESPONSIBILITY 
This trial must be conducted in compliance with the protocol, the ICH Guidance for 
Industry E6 Good Clinical Practice: Consolidated Guidance and the applicable regulatory 
requirements. Investigators must submit all essential regulatory documentation, as 
required by local and national regulations (including IRB/IEC approval of the protocol 
and informed consent form) to Revance before investigational product will be shipped to 
the trial center.  

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