International CoolSculpting: Prospective, Multi-Country, Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Phase: NA
Conditions: Non-invasive Fat Reduction
Sponsor: Allergan

 
   
 
 
 
         NCT03909100 
 
Study ID: CMO-MA-PLS-0602 
 
 
Title: International CoolSculpting: Prospective, Multi-Country Study to 
Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen 
and/or Flanks (iCool) 
 
                Protocol Date: November 20, 2019 
NCT03909100

CLINICAL INVESTIGATION PLAN
International CoolSculpting: Prospective, Multi-Country Study to Evaluate 
Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks
(iCOOL)
Protocol Number:
CMO-MA-PLS-0602
Protocol Amendment Number:
2
Investigational Product:
CoolSculpting®
Phase:
Post-Marketing
Sponsor:
Allergan Sales, LLC 
5 Giralda Farms
Madison, NJ 07940
USA
Protocol Date:
20 November 2019
Protocol Version:
Version 3.0
CONFIDENTIAL
This protocol may not be reproduced or communicated to a third party without the 
written permission of Allergan Sales, LLC.

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3
SYNOPSIS
Protocol Number: CMO-MA-PLS-0602
Title:
International CoolSculpting: Prospective, Multi-Country Study to Evaluate Patient Satisfaction for 
Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)
Investigational Product:
CoolSculpting®
Study Sites:
Approximately 8 study sites
Phase:
Post-marketing
Objectives:
Primary Objective: 
To evaluate overall patient satisfaction for non-invasive fat reduction in CoolSculpting subjects.
Secondary Objectives: 
1.
To evaluate overall satisfaction for non-invasive fat reduction in abdomen alone, flank alone, and 
abdomen and flanks combined in CoolSculpting subjects.
2.
To evaluate overall satisfaction for non-invasive fat reduction in CoolSculpting subjects by 
number of treatment cycles.
3.
To evaluate overall satisfaction for non-invasive fat reduction in CoolSculpting subjects by body 
mass index (BMI) (normal: 18.5 to < 25, overweight: 25 to ≤ 30).
4.
To evaluate change in volume of fat after CoolSculpting treatment(s) using three-dimensional
(3D) photography.
5.
To determine frequency of adverse events (AEs) including serious AEs (SAEs); and adverse 
device effect (ADEs) including serious ADEs (SADEs).
Study Design:
Study CMO-MA-PLS-0602 is a multi-country, multi-center, non-randomized, open-label, single-arm, 
medical device post-marketing study. 

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Number of Subjects: 
Approximately 100 subjects will be enrolled at approximately 8 sites.
Treatment:
Subjects will undergo CoolSculpting treatment session(s) in an outpatient clinical setting. A treatment 
session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual
massage. Treatments will be administered according to the User Manual CoolSculpting System.
Study Duration:
The study will be up to 20 weeks with up to 2 treatments sessions 8 weeks apart and final follow-up 
12 weeks after the final treatment session (measured at Week 12 for subjects who receive 1 treatment
session, or Week 20 for 2 treatment sessions).
Study Population:
Inclusion Criteria
1.
Subject (healthy volunteers) has read and signed the study written informed consent form (ICF).
2.
Male or female ≥22 years and ≤65 years of age.
3.
Subject has clearly visible fat in the flanks and/or abdomen, which in the investigator’s opinion, 
may benefit from the treatment.
4.
Subject has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the 
preceding month.
5.
Subject has a BMI of 18.5 to 30. A BMI is defined as weight in kilograms divided by height in 
meters squared (kg/m2). 
6.
Subject agrees to maintain weight (ie, within 5% of body weight) by not making any changes in 
diet or exercise routine during the course of the study.
7.
Subject agrees to have photographs taken of the treatment area(s) during the scheduled time 
periods.
Exclusion Criteria
1.
Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended 
treatment.
2.
Subject has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of 
intended treatment within the past 12 months.
3.
Subject needs to administer, or has a known history of subcutaneous injections into the area(s) of 
intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
4.
Subject is pregnant or intending to become pregnant.
5.
Subject is lactating or has been lactating in the past 6 to 9 months.
6.
Subject is unable or unwilling to comply with study requirements.

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7.
Subject is currently enrolled in a clinical study of any unapproved investigational device, 
investigational product, or any other type of medical research judged not to be scientifically or 
medically compatible with this study.
8.
Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system 
or any other metal containing implant.
9.
Subject with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold 
hemoglobinuria.
10. Subject with known sensitivity to cold or has any condition with a known response to cold 
exposure that limits blood flow to the skin such as cold urticaria or Raynaud’s disease, or 
Chilblains (pernio).
11. Subject with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene 
glycol.
12. Subject with impaired peripheral circulation in the area(s) to be treated
13. Subject with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
14. Subject with impaired skin sensation.
15. Subject with open or infected wounds.
16. Subject with bleeding disorder, or concomitant use of blood thinners, or is taking any medication 
that in the investigator’s opinion may increase the subject’s risk of bruising.
17. Subject with recent surgery or scar tissue in the area(s) to be treated.
18. Subject has history of hernia in or adjacent to the treatment area(s) site.
19. Subject with skin conditions such as eczema, dermatitis, or rashes in the area(s) to be treated.
20. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in 
the location of the treatment sites that may interfere with the treatment or evaluation (stretch 
marks is not an exclusion).
21. Subject is taking or has taken diet pills or supplements within the past 6 months.
22. Any other condition or laboratory value that would, in the professional opinion of the investigator, 
potentially affect the subject’s response or the integrity of the data or would pose an unacceptable 
risk to the subject.
23. Subject diagnosed with fibrosis.
Primary Endpoint:
The primary endpoint will be Cryolipolysis Satisfaction Questionnaire (CSQ) Item #1 measured at 
Week 12 for subjects who receive 1 treatment session and at Week 20 for subjects who receive 
2 treatment sessions. 

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Safety
Frequency of AEs including SAEs and ADEs including SADEs will be summarized.
Statistical Analysis
The primary endpoint of the study will be the overall patient satisfaction based on the CSQ Item #1 at 
12 weeks after the final treatment session (measured at Week 12 for subjects who receive 1 treatment
session, Week 20 for 2 treatment sessions) for non-invasive fat reduction in CoolSculpting subjects who
receive treatment in abdomen alone, flanks alone, or both abdomen and flanks. Subjects who have 
reported ‘Very satisfied’ and ‘Satisfied’ will be categorized as ‘Satisfied.’ The counts and percentage will
be summarized and the 95% confidence interval (CI) on the percentage will be calculated with normal 
approximation.
Secondary efficacy endpoints related to overall patient satisfaction rate on CSQ Item #1 at 12 weeks after 
the final treatment session will also be summarized along with 95% CIs. Descriptive summary statistics 
for change in volume of fat from baseline and 
 
Safety endpoints will be presented as summary tables describing frequency and type of events. 
Sample Size
The sample size will be based on providing reasonable precision for the estimate of the overall 
satisfaction rate. 
Previous studies conducted on subjects undergoing flank or abdominal fat reduction using CoolSculpting 
products reported moderately high overall satisfaction rate. The mean overall satisfaction rate was 65.8% 
from the study (Protocol: ZA15-004) based on 19 subjects, and 63.3% from another study 
(Protocol: ZA10-001) based on 60 subjects. The weighted average of rates from the 2 studies, which is 
63.9%, is now used as the initial estimate of the mean overall satisfaction rate for this planned study. A 
sample size of 98 subjects would provide a 10% margin of error (associated with 95% CI) for the estimate 
of the 63.9% expected rate. Allowing a 10% dropout during the study period, approximately 108 subjects 
will be needed for recruitment into the study.

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TABLE OF CONTENTS
1
PROTOCOL APPROVAL SIGNATURE ...........................................................................2
2
PROTOCOL AMENDMENT SUMMARY OF CHANGES .............................................3
3
SYNOPSIS ..............................................................................................................................5
TABLE OF CONTENTS ............................................................................................................10
List of In-text Tables..............................................................................................................13
4
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS .....................................14
5
INTRODUCTION................................................................................................................15
5.1
Background ................................................................................................................15
Abdominal Only Studies ................................................................................16
5.1.1
Flank Only Studies .........................................................................................17
5.1.2
Abdominal and Flank Studies ........................................................................18
5.1.3
5.2
Rationale.....................................................................................................................18
Benefit and Risks............................................................................................19
5.2.1
5.2.1.1
Benefits.........................................................................................19
5.2.1.2
Risks.............................................................................................19
6
STUDY OBJECTIVES AND ENDPOINTS ......................................................................21
6.1
Objectives...................................................................................................................21
6.2
Endpoints....................................................................................................................21
7
INVESTIGATIONAL PLAN..............................................................................................24
7.1
Overall Study Design and Plan: Description..............................................................24
Schedule of Assessments................................................................................25
7.1.1
7.2
Discussion of Study Design .......................................................................................26
7.3
Selection of Study Population ....................................................................................26
Number of Planned Subjects ..........................................................................26
7.3.1
Inclusion Criteria............................................................................................26
7.3.2
Exclusion Criteria...........................................................................................26
7.3.3
Removal of Subjects from Therapy or Assessments......................................28
7.3.4
7.4
CoolSculpting System ................................................................................................29
CoolSculpting Description .............................................................................29
7.4.1
Identity of CoolSculpting System ..................................................................30
7.4.2

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9.2.1.1
Serious Adverse Events................................................................46
9.2.1.2
Unanticipated Serious Adverse Device Effect .............................48
Warnings and Precautions..............................................................................48
9.2.2
Other Laboratory Variables............................................................................48
9.2.3
9.3
Data Safety Monitoring Board ...................................................................................48
Appropriateness of Measurements .................................................................48
9.3.1
10
STATISTICAL METHODS................................................................................................49
10.1
Determination of Sample Size....................................................................................49
10.2
Populations for Analyses............................................................................................49
10.3
Statistical Analyses.....................................................................................................49
Disposition, Baseline and Study Information.................................................49
10.3.1
10.3.1.1
Patient Disposition .......................................................................50
10.3.1.2
Patient Baseline and Characteristics.............................................50
10.3.1.3
Concomitant Therapy...................................................................50
10.3.1.4
Treatment Compliance .................................................................50
Efficacy Analyses...........................................................................................50
10.3.2
10.3.2.1
Primary Analyses .........................................................................50
10.3.2.2
Secondary Analyses .....................................................................50
10.3.2.3
Exploratory Analyses ...................................................................51
Safety Analyses ..............................................................................................52
10.3.3
Subgroup Analyses.........................................................................................52
10.3.4
Interim Analyses.............................................................................................52
10.3.5
10.4
Protocol Deviations ....................................................................................................52
11
QUALITY ASSURANCE AND QUALITY CONTROL .................................................53
11.1
Audit and Inspection ..................................................................................................53
12
QUALITY ASSURANCE AND QUALITY CONTROL .................................................54
12.1
Audit and Inspection ..................................................................................................54
12.2
Monitoring..................................................................................................................54
12.3
Data Management and Coding...................................................................................54
13
RECORDS AND SUPPLIES...............................................................................................55
13.1
Device Accountability................................................................................................55
13.2
Financing and Insurance.............................................................................................55

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14
ETHICS.................................................................................................................................56
14.1
Independent Ethics Committee or Institutional Review Board..................................56
14.2
Regulatory Authorities ...............................................................................................56
14.3
Ethical Conduct of the Study......................................................................................56
14.4
Informed Consent.......................................................................................................56
14.5
Subject Confidentiality...............................................................................................57
15
REPORTING AND PUBLICATION, INCLUDING ARCHIVING...............................58
16
REFERENCES .....................................................................................................................59
17
APPENDICES ......................................................................................................................60
17.1
Investigator Signature Page........................................................................................61
17.2
Allergan iCOOL (CMO-MA-PLS-0602) Questionnaire Schedule............................62
17.3
Cryolipolysis Satisfaction Questionnaire – Belly and Love Handles ........................63
17.4
Cryolipolysis Satisfaction Questionnaire (CSQ) - Belly............................................65
17.5
Cryolipolysis Satisfaction Questionnaire (CSQ) – Love Handles .............................67
17.6
Cryolipolysis General Procedure Questionnaire Belly and/or Love Handles............69
17.7
Cryolipolysis Psychosocial Impact Questionnaire - Midsection (CPIQ – M) ...........71
List of In-text Tables
Table 1.
Schedule of Activities.....................................................................................25

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4
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
LIST OF ABBREVIATIONS
3D
three-dimensional
AE
adverse event
ADE
adverse device effect
BMI
body mass index
CI
confidence interval
CRF
case report form
CSQ
Cryolipolysis Satisfaction Questionnaire
eCRF
electronic case report form
EDC
electronic data capture
FDA
Food and Drug Administration
GCP
Good Clinical Practice
ICF
informed consent form
IEC
independent ethics committee
IRB
institutional review board
ISO
International Organization for Standardization
PRO
patient-reported outcome
SADE
serious adverse device effect
SAE
serious adverse event

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dissatisfaction; 2 subjects requested refunds, and 4 subjects who were initially dissatisfied with 
their fat reduction received follow-up cryolipolysis treatments without charge and were 
subsequently satisfied with their results. The investigators believe this represents a high level of 
patient satisfaction (Stevens et al, 2013).
A retrospective chart review study was conducted on 27 males and 98 females (n = 125) who 
received 554 cryolipolysis treatment cycles at the Washington Institute of Dermatologic Laser 
Surgery. Subjects who received cryolipolysis treatment during a 12-month consecutive period 
(September 1, 2013 to August 29, 2014) were evaluated. Treatment sites included the lower 
(n = 203, 36.6%) and upper abdomen (n = 66, 11.9%), flanks, back, thighs, and chest. Once the 
treatment applicator was positioned on the patient, the 60-minute treatment cycle was initiated. 
Subjects were noted as developing delayed post-treatment pain if the patient experienced at least 
2 of the following symptoms after cryolipolysis: neuropathic symptoms such as stabbing, 
burning, and shooting pain within treatment areas; increased pain causing sleep disruption; and 
discomfort unresponsive to analgesic medications. Females (mean age of 39 years) undergoing 
abdominal cryolipolysis were at greatest risk of experiencing delayed post-treatment pain, which 
developed, on average, 3 days after treatment and was self-limited and resolved completely 
without long-term sequelae within 11 days. The number of treatment cycles did not impact 
whether a patient developed delayed post-treatment pain. (Keaney et al, 2015).
In a Chinese population study, investigators compared the clinical efficacy and patient 
satisfaction of a novel cryolipolysis device (ZELTIQ®) for body contouring after a single 
treatment and after 2 treatments in a commercial setting. Twenty-one subjects received a single 
treatment lasting 60 minutes, and 12 subjects received 2 treatments lasting 60 minutes each, on 
average of 3 months apart. The thickness of fat at the treatment site is measured using a calliper, 
as well as standardized clinical photos, that were collected at baseline and 2 months 
post-treatment. There was a significant improvement (p < 0.0001) in the first group of subjects 
and after both treatments compared to the baseline in the second group of subjects for treatment 
on the abdomen. Fifty-seven percent of patients thought the treatment reached or exceeded their 
expectations, whereas 43% expected a more dramatic effect. Subjectively, 80% felt satisfied to 
very satisfied, and the rest were indifferent. Eighty-six percent would consider having non-
invasive cryolipolysis performed on another part of their body and would consider 
recommending this treatment to family and friends (Shek et al, 2012).
Based on these studies, cryolipolysis is well tolerated, has a high patient satisfaction, and is 
effective in reducing fat in the abdominal region.
Flank Only Studies
5.1.2
Cryolipolysis received US FDA clearance for the reduction of fat in the flank area in 2010 
(Klein et al, 2017).
In addition to the Klein et al, 2017 and Dierickx et al, 2013 papers described above, there are 2 
other flank studies that describe safety and efficacy of cryolipolysis.
To test the safety and efficacy of a new sharply contoured cryolipolysis vacuum applicator, a 
study was conducted that treated 20 flanks on female subjects, with 2 treatment cycles 

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(60 minutes each) delivered sequentially to each flank. Efficacy was evaluated 12 weeks 
post-treatment by physicians performing a blinded, independent review of clinical photographs. 
Safety was assessed by the treating physician who monitored subjects for side effects and AEs. 
Four blinded, independent physician reviewers properly identified the pre- and post-treatment 
photographs 94.4% of the time. Improvement results, scored from 0 (none) to 10 (complete), 
showed an average score of 4.3 points (43%). Side effects were limited to erythema, edema, 
bruising, and numbness or tingling at the treatment site and resolved without intervention before
the 12-week follow-up visit (Bernstein et al, 2014).
Another study investigated whether fat reduction in humans caused by cold exposure is 
associated with alteration in local sensory function or nerve fibers. Ten subjects were treated 
with a prototype cooling device on 1 of their flanks, and the other side was left untreated as a 
control. Fat reduction was assessed in 9 of the 10 subjects via ultrasound before treatment and at 
the 2- and 6-month follow-up visits. Clinical observations documented immediately after 
treatment were consistent with those anticipated for local inflammation (eg, edema, minor pain, 
erythema), the majority of which resolved within a few days after treatment; no clinical findings 
were reported for any of the treatment sites at the 2- or 6-month follow-up visits. Treatment 
resulted in a normalized fat-layer reduction of 20.4% at 2 months after treatment and 25.5% at 
6 months after treatment. While transient reduction in sensation occurred in 6 of 9 subjects 
assessed by neurologic evaluation, all sensation returned by a mean of 3.6 weeks after treatment; 
biopsies showed no long-term change in nerve fiber structure. There were no lasting sensory 
alterations or observations of skin damage in any of the evaluated subjects (Coleman et al, 2009).
Based on these studies, cryolipolysis is well tolerated and is effective in reducing fat in the flank 
region.
Abdominal and Flank Studies
5.1.3
A study of 8 adult males and 27 females (n = 35) assessed multiple same-day treatments on the 
lower abdomen and 2 flanks and effects on serum lipid levels and liver tests. Treatment consisted 
of 1 cycle each to the lower abdomen and simultaneous treatment of both flanks. The time 
between the abdomen and flanks procedures was not to exceed 30 minutes. Erythema, numbness, 
and edema were experienced by the majority of subjects immediately after the procedures. In 
most cases, these signs and symptoms were considered by the investigator to be minor or 
moderate in severity, and, in all cases, they resolved without treatment. At the Week 12 
examination, all treatment sites appeared normal, and no subjects reported any associated 
symptoms. Immediately after the procedures, the mean pain score was 4 on a scale of 1 to 10. 
There were no reports of late-onset pain. There were no clinically meaningful changes from 
baseline to any subsequent time point in either the serum lipid tests or liver tests. Three subjects
experienced AEs, all judged by the investigator to be unrelated to the procedures. Therefore, 
multiple cycles of same-day cryolipolysis treatment of the lower abdomen and both flanks are
well tolerated and safe (Klein et al, 2017).
5.2
Rationale
Most clinical studies on CoolSculpting have been conducted at US sites; therefore, only a limited 
number of subjects have been treated and studied at international sites. There is also insufficient 

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information regarding patient-centric outcomes related to the CoolSculpting procedure and the 
psychosocial impact of localized fat. A literature search was performed to assess psychosocial 
impact tools for body contouring, but nothing relevant was found. Therefore, Allergan has 
developed a de novo research instrument, 
 to assess the psychosocial impact of 
treating subjects with CoolSculpting on the abdomen and flank.
Benefit and Risks
5.2.1
5.2.1.1
Benefits
Fat reduction in the treatment area is anticipated to provide an aesthetic benefit and the use of 
this non-invasive system will eliminate the need for an invasive procedure that requires 
anesthesia or recovery time.
5.2.1.2
Risks
Although this study presents minimal risks to the subject, there is the potential for some risk 
when any medical procedure is performed. 
Anticipated Device Effects
These are known effects of the CoolSculpting Procedure, previously recorded in prior studies as 
transient and/or temporary effects related to the cold application and/or vacuum pressure inherent 
in the treatment. Anticipated effects of the device which will not be considered AEs include: 

inflammation of the subcutaneous fat layer, which is a desired effect of the procedure;

sensations of coldness, stinging, burning, pinching, or pressure associated with placement 
of the applicator and the initiation of the cold treatment;

known skin effects (eg, blanching; erythema, bruising, purpura, petechiae, swelling, 
discomfort, tenderness, or soreness at the treatment site, all mild to moderate in nature), 
which are temporary effects that resolve spontaneously shortly after the procedure; and

localized sensory changes (eg, numbness, tingling) at the treatment area resolving within 
12 weeks of the procedure.
If the severity of these anticipated effects causes disruption to the subject’s daily activities, then 
they will be evaluated as a potential adverse effect.

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Potential Adverse Effects
Potential Adverse Effect
Description
Severe Bruising
The appearance of bruising (purple discoloration); purpura (purple colored spots 
or patches); or petechiae (pin point red dots) that is rated as severe by the 
investigator.
Prolonged Bruising
Bruising lasting longer than 1 month.
Severe Erythema
The appearance of erythema (redness) that is rated as severe by the investigator.
Prolonged erythema
Erythema lasting longer than 2 weeks.
Severe Swelling
The appearance of swelling (edema) that is rated as severe by the investigator.
Prolonged swelling
Swelling lasting longer than 1 month.
First Degree Burn
Skin damage from burns may be due to hot or cold. A first degree burn is 
superficial and causes local inflammation of the skin. The inflammation is 
characterized by pain, redness, and mild swelling. The skin may be very tender to 
touch.
Second Degree Burn
Second degree burns are deeper and, in addition to the pain, redness, and
inflammation, there is also blistering of the skin. 
Third Degree Burn
Third degree burns are deeper still, involving all layers of the skin. Because the 
nerves and blood vessels are damaged, third degree burns appear white, leathery, 
and tend to be relatively painless.
Cold-induced Panniculitis
Severe inflammation which requires medical or surgical intervention.
Skin Pigment Changes
The appearance of hyperpigmentation or hypopigmentation in the treatment area.
Infection
Infection at the treatment site, diagnosed by a physician and requiring medical 
intervention.
Discomfort During Procedure
Discomfort reported during the procedure that is intolerable to the subject and 
results in an interruption or discontinuation of the procedure.
Discomfort Post Procedure
Significant discomfort, pain, cramping, tenderness, soreness, muscle spasm 
following the procedure which results in medical intervention (physician visit 
and/or prescription pain reliever).
Prolonged Sensory Alteration 
Post Procedure
Sensory changes (numbness, tingling, burning sensation) that are prolonged (ie, 
lasting longer than 12 weeks).
Sensory Alteration Requiring 
Medical Intervention
Sensory changes (pain, burning, stinging, hypersensitivity) with a severity 
warranting medical intervention.
Vasovagal Symptoms
The occurrence of symptoms of anxiety, light-headedness, dizziness, nausea, 
sweating, near syncope, or syncope (fainting).
Gastrointestinal Symptoms
Nausea, bloating, or diarrhea temporally related to the procedure (within the first 
few hours after the procedure).
Contour Irregularity
Significant indentation or contour irregularity in the treatment area that would 
require surgical intervention.
Allergic/Irritant Contact 
Dermatitis
Itchy rashes and skin peeling that may result from prolonged exposure to gel pad 
or applicator pressure.
Subcutaneous Induration
Hardness within the treatment area, either as general firmness or discrete 
nodules.
Paradoxical Hyperplasia
Visibly enlarged tissue volume within the treatment area which may develop 
2-5 months after treatment. 
Hernia
Creation or exacerbation of hernia. Hernia is defined as a protrusion of an organ 
or the fascia of an organ through the wall of the cavity that normally contains it.
Other
Any other untoward medical event determined by the investigator to be an AE, 
regardless of the relationship to the device or treatment.

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6
STUDY OBJECTIVES AND ENDPOINTS
6.1
Objectives
Primary Objective
To evaluate overall patient satisfaction for non-invasive fat reduction in CoolSculpting subjects.
Secondary Objectives
1. To evaluate overall satisfaction for non-invasive fat reduction in abdomen alone, flank 
alone, and abdomen and flanks combined in CoolSculpting subjects. 
2. To evaluate overall satisfaction for non-invasive fat reduction in CoolSculpting subjects 
by number of treatment cycles.
3. To evaluate overall satisfaction for non-invasive fat reduction in CoolSculpting subjects 
by BMI (normal: 18.5 to < 25, overweight: 25 to ≤ 30).
4. To evaluate change in volume of fat after CoolSculpting treatment(s) using 3D
photography.
5. To determine frequency of AEs including SAEs; and ADEs including SADEs.
6.2
Endpoints
Primary Endpoint
The primary endpoint will be CSQ Item #1 measured at Week 12 for subjects who receive 
1 treatment session and at Week 20 for subjects who receive 2 treatment sessions.
The analysis on the primary endpoint will be the proportion of subjects with “satisfied” or “very 
satisfied” on CSQ Item #1.

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All individual items and the total score are transformed to a 0 (no impact) to 100 (highest 
impact) point scale.

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7
INVESTIGATIONAL PLAN
7.1
Overall Study Design and Plan: Description
Study CMO-MA-PLS-0602 is a multi-country, multi-center, non-randomized, open-label, single-
arm, medical device post-marketing study. See Table 1 Schedule of Assessments.

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7.2
Discussion of Study Design
The background and rationale that led to the study design is described in Section 5.1.
7.3
Selection of Study Population
Number of Planned Subjects 
7.3.1
Approximately 100 subjects will be enrolled at approximately 8 sites.
Refer to the statistical considerations on which the numbers are based in Section 10.1.
Inclusion Criteria
7.3.2
To be eligible for study entry, subjects must satisfy all of the following criteria:
1. Subject (healthy volunteers) has read and signed the study written ICF as described in 
Section 14.4.
2. Male or female ≥22 years and ≤65 years of age.
3. Subject has clearly visible fat in the flanks and/or abdomen, which in the investigator’s 
opinion, may benefit from the treatment.
4. Subject has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) 
in the preceding month.
5. Subject has a BMI of 18.5 to 30. A BMI is defined as weight in kilograms divided by 
height in meters squared (kg/m2). 
6. Subject agrees to maintain weight (ie, within 5% of body weight) by not making any 
changes in diet or exercise routine during the course of the study.
7. Subjects agree to have photographs taken of the treatment area(s) during the scheduled 
time periods.
Exclusion Criteria
7.3.3
Subjects will be excluded from the study if one or more of the following criteria are applicable:
1. Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of 
intended treatment.
2. Subject has had a non-invasive fat reduction and/or body contouring procedure in the 
area(s) of intended treatment within the past 12 months.

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3. Subject needs to administer, or has a known history of subcutaneous injections into the 
area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.
4. Subject is pregnant or intending to become pregnant.
5. Subject is lactating or has been lactating in the past 6 to 9 months.
6. Subject is unable or unwilling to comply with study requirements.
7. Subject is currently enrolled in a clinical study of any unapproved investigational device, 
investigational product, or any other type of medical research judged not to be 
scientifically or medically compatible with this study
8. Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery 
system or any other metal containing implant.
9. Subject with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal 
cold hemoglobinuria.
10. Subject with known sensitivity to cold or has any condition with a known response to cold 
exposure that limits blood flow to the skin such as cold urticaria or Raynaud’s disease, or 
Chilblains (pernio).
11. Subject with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or 
propylene glycol.
12. Subject with impaired peripheral circulation in the area(s) to be treated
13. Subject with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.
14. Subject with impaired skin sensation.
15. Subject with open or infected wounds.
16. Subject with bleeding disorder, or concomitant use of blood thinners, or is taking any 
medication that in the investigator’s opinion may increase the subject’s risk of bruising.
17. Subject with recent surgery or scar tissue in the area(s) to be treated.
18. Subject has history of hernia in or adjacent to the treatment area(s) site.
19. Subject with skin conditions such as eczema, dermatitis, or rashes in the area(s) to be 
treated.
20. Subject has any dermatological conditions, such as moderate to excessive skin laxity, or 
scars in the location of the treatment sites that may interfere with the treatment or 
evaluation (stretch marks is not an exclusion).

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21. Subject is taking or has taken diet pills or supplements within the past 6 months.
22. Any other condition or laboratory value that would, in the professional opinion of the 
investigator, potentially affect the subject’s response or the integrity of the data or would 
pose an unacceptable risk to the subject.
23. Subject diagnosed with fibrosis.
Removal of Subjects from Therapy or Assessments
7.3.4
Notification of early participant discontinuation from the study and the reason for
discontinuation will be provided to the sponsor and will be clearly documented on the
appropriate case report form (CRF).
Reasons for discontinuation from the study may include the following:

Completed

Other

Physician decision

Protocol deviation

Screen failure

Site terminated by sponsor

Study terminated by sponsor

Technical problems

Withdrawal by subject

Lost to follow-up
Subjects who do not comply with the protocol or who withdraw consent will not be replaced. 
Subjects who stop study treatment for any other reason will not be replaced. Subjects are free to 
withdraw from the study at any time without providing reason(s) for withdrawal and without 
prejudice to further treatment. The reason(s) for withdrawal will be documented in the CRF.
Subjects withdrawing from the study will be encouraged to complete the same final evaluations 
as subjects completing the study according to this protocol, particularly safety evaluations. The 
aim is to record data in the same way as for subjects who completed the study.
Reasonable efforts will be made to contact subjects who are lost to follow-up. These efforts must 
be documented in the subject’s file. 

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The sponsor has the right to terminate the study at any time in case of SAEs or if special 
circumstances concerning the CoolSculpting procedure or the company occur, making further 
treatment of subjects impossible. In this event, the investigator(s) will be informed of the reason 
for study termination.
Pregnancy
Female patients will be instructed that known or suspected pregnancy occurring during the study
should be confirmed and reported to the investigator, who fill out a provided pregnancy 
surveillance form. The form needs to be sent to the sponsor within 24 hours of awareness of a 
confirmed pregnancy to the following contact information: 
CoolSculptingProductSurveillance@allergan.com
Once pregnancy is confirmed, the subject will be immediately withdrawn from the study. Upon 
discontinuation from the study, only those procedures that would not expose the subject to undue 
risk will be performed. The investigator should also be notified of pregnancy occurring during 
the study but confirmed after completion of the study. In the event that a subject is subsequently 
found to be pregnant after inclusion in the study, any pregnancy will be followed to term, and the 
status of mother and child will be reported to the sponsor after delivery using the second page of 
the pregnancy surveillance form. 
Full details will be recorded on the withdrawal page of the CRF.
7.4
CoolSculpting System
CoolSculpting Description
7.4.1
Patients will undergo CoolSculpting treatment in an outpatient clinical setting. A treatment
session on any given day(s) comprises one or more timed segments of cooling called treatment 
cycles, which overall comprise the treatment plan for the patient. Treatments will be 
administered according to the User Manual CoolSculpting System that has been prepared for 
specific countries. The CoolSculpting System, also labelled as the ZELTIQ System or the 
ZELTIQ Breeze System (system), is a non-invasive cooling and heating device that applies 
controlled cooling to a treatment site on the patient’s skin. 
Uses of the system in cooling mode include: 

Fat-layer reduction through cold-assisted lipolysis. 

Minimizing pain and thermal injury during laser and dermatological treatments. 

Acting as a local anesthetic for procedures that induce minor local discomfort. 
The system can also provide localized thermal therapy (hot or cold) to minimize pain for post-
traumatic and/or post-surgical pain and to temporarily relieve minor aches and pains and muscle 
spasms. 

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The massage function can also be used for temporary:

relief of minor aches and spasms

improvement in local circulation 

reduction in the appearance of cellulite
The investigator or his/her designee is responsible for the following:

explaining the procedure to the patient 

verifying that instructions are followed properly

maintaining accurate records 
Identity of CoolSculpting System
7.4.2
The CoolSculpting System is comprised of a control unit, a surface or vacuum applicator, and 
supplies such as cards, foam borders, gel pads, liners, pre-treatment skin wipes, and securement 
systems. The applicators, foam borders, gel, gel pads, liners, pre-treatment skin wipes, and 
securement systems are patient-applied parts.
During a treatment, the operator applies a gel/gel pad and applicator to the patient’s skin. The 
vacuum applicator draws tissue into the applicator cup and holds the tissue against the cooling 
surfaces of the applicator; the surface applicator does not use vacuum pressure. The operator 
starts the treatment. Sensors in the cooling surfaces of the applicator monitor the skin surface, 
providing feedback that controls the rate of heat flux. The gel/gel pad protects the skin by 
providing thermal coupling at the interface between the cooling surfaces of the applicator and the 
skin. The card provides cycles and profiles for use with the system.
The CoolSculpting System operates at temperatures below 0°C, which can freeze tissue. 
Therefore, the system monitors tissue during cooling and employs multiple safety features, 
including the Freeze Detect system, to minimize the risk of damage to tissue. In spite of these 
multiple safety features, on rare occasions, a possible freeze condition may occur that can be 
detected by the Freeze Detect System.
The Freeze Detect system is comprised of several features, including thermal sensors and 
proprietary algorithmic software. Freeze Detect is an integral part of the CoolSculpting System 
and is automatically employed when a treatment is initiated. When the Freeze Detect system 
detects a possible freeze condition, it stops the treatment and displays a Z409 message. If this 
message is received, remove the applicator and gel pad or gel, and assess the tissue before taking 
further action. The current recommended practice is to wait at least 24 hours before retreating the 
area relating to a Z409 error message. Failure to follow instructions could result in injury to the 
participant, including first- or second-degree burns. Second-degree burns or complications of 
second-degree burns may result in hyperpigmentation.

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7.4.2.1
Control Unit
Control Unit - Front View
Components - Front View
1. Rail: When the applicator is resting on top of the control unit, the rail helps keep the 
applicator in place. In addition, the rail is used as a handle to move the system.
2. Vents: Vents provide airflow that reduces heat build-up inside the control unit. Ensure all 
vents are free from obstructions when the control unit is in operation.
3. Drawer: The drawer provides storage space for supplies and user documentation.
4. Casters and Locks: The control unit has four casters that swivel. Each caster has a lock. 
Always engage the locks on all four casters before you use the control unit.
5. Screen: The screen displays system controls, information about the status of the system, 
information about the treatment, and messages for the operator.

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Control Unit - Rear View
Components: Control Unit, Rear View
1. Rail: When the applicator is resting on top of the control unit, the rail helps keep the 
applicator in place. In addition, the rail is used as a handle to move the system.
2. Vents: Vents provide airflow that reduces heat build-up inside the control unit. Ensure that 
all vents are free from obstructions when the control unit is in operation.
3. Latches: The latches lock the upper and lower modules of the control unit together.
4. Antenna: The antenna and data modem send data to ZELTIQ (availability and use of the 
data modem are subject to regional limitations).
5. Casters and locks: The control unit has four casters that swivel. Each caster has a lock. 
Always engage the locks on all four casters before you use the control unit.
6. Cleats: When the power cord is not in use, wrap it loosely around the cleats.
7. Chiller tank cap: The chiller tank cap provides access to the chiller tank for checking the 
coolant level and adding coolant.
8. Support Arm: Drape the applicator cable over the support arm to minimize drag on the 
connections and to keep the cable out of your way. Use the Velcro ® straps to secure the 
cable to the support arm.
7.4.2.2
Applicator
The applicator delivers controlled cooling to the treatment site.
The applicator consists of the applicator connector, the applicator cable, and the applicator head.
The applicator is used with supplies provided by ZELTIQ, an Allergan affiliate.

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7.5
7.6
Method of Assigning Subjects to Treatment Groups
At screening, after the study participant has signed the ICF, the study participant will be assigned 
a subject number sequentially based on the order in which the study participant is screened into 
the study. This subject number will serve as the study participant identification number on all 
study documents.
7.7
Blinding
This is an open-label study.
7.8
Prior and Concomitant Therapy
All concomitant therapies that are part of routine care are allowed and can be used during the 
study.
7.9
Treatment Compliance
The study investigators are responsible for performing the study in compliance with the protocol. 
Non-adherence to the protocol is to be classified as a protocol violation, protocol deviation, or 
protocol exemption, as defined below.
Protocol Violation
A violation is any non-adherence to the protocol that may result in significant additional risk to 
the subject (eg, enrollment of a subject who does not meet the study criteria). A protocol 
violation can also be an event of non-adherence to Good Clinical Practices (GCPs) that may 
impact subject safety (eg, failure to obtain proper consent before performing study procedures). 
Violations should be reported to the study sponsor and the institutional review board (IRB)
within 5 working days if they occur.
Protocol Deviation
A deviation is any non-adherence to study procedures that does not result in additional risk to the 
subject (eg, subject missed visit). Protocol deviations are not required to be reported to the IRB; 
however, they must be recorded on the study CRFs and may be reported and reviewed in 
conjunction with the progress report as part of the annual review process.

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8.3
Duration of Treatment
Each treatment session will comprise a number of treatment cycles, each lasting up to 
45 minutes, depending on the applicator used. Subjects will have up to 2 treatment sessions, with 
the second treatment session approximately 8 weeks after the first one.

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9.2
Safety Assessments
Adverse Events
9.2.1
Throughout the course of the study, all AEs will be reported and monitored on an AE CRF, 
including event name, duration, seriousness, relatedness, severity, action taken, and outcome. If 
AEs occur, the first concern will be the safety of the study participants.
All events and device deficiencies are to be recorded on the corresponding CRF for the patient 
upon the site becoming aware of said event.
AEs will be collected throughout the study once there is a signed ICF. At each visit, the 
investigator or designated study staff will solicit and assess the patient for AEs. Previously 
recorded AEs and changes in therapy/concomitant medications are to be updated as necessary. 
All reportable AEs and clinically significant abnormal laboratory findings will be documented on 
the appropriate electronic CRF (eCRF).
Adverse Event Definition
An AE is defined in accordance with International Organization for Standardization (ISO) 14155 
as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users, or other persons, if related to the 
investigational medical device. This definition includes events related to the investigational 
medical device or comparator and events related to the procedures involved. Disease signs and 
symptoms that existed before the study treatment are not considered AEs unless the condition 
recurs after the participant has recovered from the pre-existing condition or the condition 
worsens in intensity or frequency during the study.
AEs will be monitored throughout the study once the subject has signed the informed consent 
form. At each post-baseline visit, the investigator will begin querying for AEs by asking each 
participant a general, non-directed question such as “Have you had any changes to your 
condition since your last visit?” Previous AEs and changes in therapy/concomitant medications 
are to be updated. Directed questioning and examination will then be done as appropriate. All 
reportable AEs and clinically significant abnormal laboratory findings will be documented on the 
appropriate eCRF.
Adverse Device Effect
An ADE is defined in accordance with ISO 14155 as “an AE related to the use of an 
investigational medical device.” This definition includes any AEs resulting from insufficient or 
inadequate instructions for use, deployment, implantation, installation, or operation, or any 
malfunction of the investigational medical device as well as any event resulting from use error 
(per ISO 62366) or from intentional misuse of the investigational medical device. 

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Device Deficiency or Complaints
A device deficiency is defined in accordance with ISO 14155 as inadequacy of a medical device 
including issues with respect to its identity, quality, durability, reliability, safety, or performance. 
Device deficiencies include malfunctions, use errors, and inadequate labelling.
If a device deficiency occurs, the investigator will notify Allergan using the CRF. Device 
deficiencies shall be documented throughout the study and appropriately managed by Allergan. 
The Clinical Trial Site will enter all the information regarding device deficiency into the 
appropriate CRFs. Allergan shall review all device deficiencies and determine and document in 
writing whether they could have led to a SADE. These shall be reported to the regulatory 
authorities and IRBs as required by Federal regulations.
Assessment of Severity
Severity is a clinical determination of the intensity of an AE. The severity assessment for a 
clinical AE will be assigned a category by the investigator as follows:
Mild
An AE that is easily tolerated by the subject, causes minimal discomfort, may 
require only minimal treatment and does not interfere with everyday activities.
Moderate
An AE that is sufficiently discomforting to interfere with normal everyday 
activities; intervention may be needed, but poses no significant or permanent 
risk of harm.
Severe
An AE that prevents normal everyday activities; treatment or other intervention 
usually needed.
If there is a change in severity of an AE, it must be recorded as a separate event.
Assessment of Causality
Relationship to a device refers to a determination of the relationship (if any) between an AE and 
the device. A causal relationship is present if the investigator determines that there is a 
reasonable possibility that the AE may have been caused by the device.
An AE could be considered procedure-related when, in the judgment of the investigator, it is 
reasonable to believe that the event is associated with the procedure, regardless of the 
relationship to the study device. Procedure-related causes that contribute to the occurrence of the 
event can be attributed to other products, surgical techniques, or medications required 
specifically for the procedure.
Every effort will be made by the investigator to assess the relationship of the AE, if any, to the 
device and/or study procedure. Causality should be assessed using the categories presented in the 
following table:

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Not related
Clinical event of which the relationship to the device and/or procedure 
can be excluded, such as if the event is incompatible time relationship to 
study procedure and/or use of the device, involves a body part or organ 
not expected to be affected by the device or procedure, could be 
explained by underlying disease or other drugs or chemicals or is 
incontrovertibly not related to the study device, and is not due to use 
error.
Unlikely
Clinical event whose time relationship to use of the device and/or study 
procedure makes a causal connection improbable, but that could plausibly 
be explained by underlying disease or other drugs or chemicals.
Possible
Clinical event with a reasonable time relationship to the use of the device 
and/or study procedure, but that could also be explained by concurrent 
disease or other drugs or chemicals. Cases were relatedness cannot be 
assessed or no information has been obtained should also be classified as 
possible.
Probable
Clinical event with a reasonable time relationship to the use of the device 
and/or study procedure, and is unlikely to be attributed to concurrent 
disease or other drugs or chemicals.
Causal relationship
Clinical event with plausible time relationship to the use of the device 
and/or study procedure, is a known side effect of the product category the 
device belongs to or of similar devices and procedures; follows a known 
response pattern to the medical device; involves a body-site or organ that 
the device or procedures are applied to and/or influence; harm is due to 
error in use, and that cannot be explained by concurrent disease or other 
drugs or chemicals.
Follow-up of Adverse Events
All investigators should follow up with subjects with AEs until the event is resolved or until, in 
the opinion of the investigator, the event is stabilized or determined to be chronic. Details of AE 
resolution must be documented in the CRF.
Documentation and Reporting of Adverse Events
AEs should be reported and documented in accordance with the procedures outlined below. All 
AEs occurring during the study must be documented on the relevant CRF pages. The following 
data should be documented for each AE in the appropriate CRF fields:

Description of the symptom event.

Classification of ‘serious’ or ‘not serious.’

Severity.

Date of first occurrence and date of resolution (if applicable).

Action taken.

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
Causal relationship.

Outcome of event.
9.2.1.1
Serious Adverse Events
Serious Adverse Event Definition
An SAE is defined as an AE that: 

led to death

led to serious deterioration in the health of the subject, that either resulted in:
o
a life-threatening illness or injury; or
o
a permanent impairment of a body structure or a body function, or
o
in-patient or prolonged hospitalization; or
o
medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function; or
o
if a subject becomes pregnant, then spontaneous abortion, fetal distress, fetal 
death, or a congenital abnormality or birth defect is considered an SAE
In addition, medical and scientific judgment is required to decide if prompt notification is 
required in situations other than those defined for SAEs above. This may include any event that 
the investigator regards as serious that did not strictly meet the criteria above but may have 
jeopardized the subject or required intervention to prevent one of the outcomes listed above, or 
that would suggest any significant hazard, contraindication, side effect, or precaution that may be 
associated with the use of the investigational product.
Serious Adverse Device Effect (SADE)
An ADE that resulted in a SAE or that might have led to any SAE consequences if a suitable 
action had not been taken or intervention had not been made.
All device or surgical related SAEs must be entered into the electronic data capture (EDC)
system within 24 hours of being notified of the event. The sponsor will be notified by EDC 
system once the SAE electronic form has been submitted.

The relationship of the clinical event to the devices and procedure should be reported on 
the Form and will be determined by the investigator.

Following evaluation of each SAE, the responsible ethics committee will be notified as 
appropriate based on national regulations.

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
All SAEs that occur from the time the ICF is signed through to their final study visit must 
be reported to the sponsor. In addition to entering the information into the EDC system, 
the investigator must:
o
Notify the sponsor immediately (within 24 hours) by emailing the Allegan 
Product Surveillance team at: 
CoolSculptingProductSurveillance@allergan.com using SAE form.
The following SAE information should be provided:

Description of the symptom event (including treatment dates, areas treated, event 
description, etc.)

Applicator(s) and Serial Number used during treatment

Classification of ‘serious’ or ‘not serious’

Severity

Date of first occurrence and date of resolution (if applicable)

Action taken

Causal relationship

Outcome of event Report as much information within 24 hours regardless of the amount 
of information available, although the investigator is expected to provide as much 
information as possible.
Obtain and maintain in his/her files all pertinent medical records, information, and medical 
judgments from colleagues who assisted in the treatment and follow-up of the subject.
Provide the sponsor with a complete, written case history (AE report form) that includes a 
statement as to whether the event was or was not related to the use of the investigational device 
or procedure.
The sponsor (or its representative) will report all SAEs associated with the use of the study 
device to the regulatory agencies (Ethics Committee, Competent Authorities) as appropriate 
according to relevant standard operating procedures and to the national laws of the country 
where the trial is performed.
In every SAE, appropriate measures should be taken to treat/resolve and monitor the subject. The 
investigator should keep Allergan closely informed of the progress as related to the SAE. Any 
subjects who are withdrawn from the study due to an AE shall still be followed until the outcome 
is resolved.
Details of the procedures to be followed if a pregnancy occurs are provided in Section 7.3.4.

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9.2.1.2
Unanticipated Serious Adverse Device Effect 
Unanticipated Serious Adverse Device Effect Definition
An unanticipated serious ADE is a SADE effect that by its nature, incidence, severity, or
outcome has not been identified in the current version of the risk analysis report. 
Warnings and Precautions 
9.2.2
Unauthorized modification or repair of the control unit, its components, or supplies may result in 
unsafe conditions and/or impaired performance. No modification of this equipment is allowed 
without express authorization from ZELTIQ. Any unauthorized modification or repair will void 
the warranty.
CoolSculpting System use has not been studied in children, those who are pregnant or lactating, 
or who have:

Known sensitivity to cold such as cold urticaria, Raynaud’s disease, or Chilblains (pernio)

Known sensitivity or allergy to fructose, glycerine, isopropyl alcohol, or propylene glycol

Impaired peripheral circulation in the area to be treated

Neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy

Impaired skin sensation

Open or infected wounds

Bleeding disorders or concomitant use of blood thinners

Recent surgery or scar tissue in the area to be treated

Hernia in or adjacent to the treatment site

Skin conditions such as eczema, dermatitis, or rashes in the area to be treated
Other Laboratory Variables
9.2.3
Screening for pregnancy will be performed (urine β-HCG at Screening, Treatment 1, and at 
Treatment 2 only).
9.3
Data Safety Monitoring Board
Not applicable.
Appropriateness of Measurements
9.3.1
The efficacy and safety assessments planned for this study are widely used and generally 
recognized as reliable, accurate, and relevant to the disease condition.

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10
STATISTICAL METHODS
The purpose of the study is to obtain PROs and have more subjects treated and studied at
international sites. There is no statistical hypothesis to prove in this study. More details on the 
methods of statistical analysis, on statistical summary, and on the derivation of some statistical 
variables can be found from the statistical analysis plan.
10.1 Determination of Sample Size
The primary objective of this Phase IV study is to estimate the overall satisfaction rate, which is 
the proportion of subjects who report overall satisfaction with CoolSculpting treatment in 
real-world clinical settings. Consequently, the sample size will be based on providing reasonable 
precision for the estimate of overall satisfaction rate.
Previous studies conducted on subjects undergoing flank or abdominal fat reduction using 
CoolSculpting products reported moderately high overall satisfaction rate. The mean overall 
satisfaction rate was 65.8% from the study (protocol: ZA15-004) based on 19 subjects, and 
63.3% from another study (Protocol: ZA10-001) based on 60 subjects. The weighted average of 
rates from the 2 studies, which is 63.9%, is now used as the initial estimate of the mean overall 
satisfaction rate for this planned study. A sample size of 98 subjects would provide a 10% 
margin of error (associated with 95% CI) for the estimate of the 63.9% expected rate. Allowing a 
10% dropout during the study period, approximately 108 subjects will be needed for recruitment 
into the study.
10.2 Populations for Analyses
For purposes of analysis, the following populations are defined:
Population
Description
Enrolled 
All participants who sign informed consent
Evaluable
All participants who sign the ICF, have at least one of the procedures conducted, and also report
the CSQ Item #1 at 12 weeks after the final treatment (measured at Week 12 for participants who 
receive 1 treatment session and at Week 20 for participants who receive 2 treatment sessions).
Safety
All participants who have at least one of the procedures conducted.
10.3 Statistical Analyses
The statistical analysis plan will be developed and finalized before database lock and will 
describe the participant populations to be included in the analyses. This section is a summary of 
the planned statistical analyses of the primary, secondary endpoints, exploratory endpoints, and
safety parameters.
Disposition, Baseline and Study Information
10.3.1
In general, the disposition data, patient baseline and characteristics data, and concomitant 
therapy data will be summarized descriptively. The categorical variables will be presented with 

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count and percentage and the continuous variables will be presented with mean, standard 
deviation, median, minimum, and maximum.
10.3.1.1
Patient Disposition
The number of subjects who have enrolled into the study, the number and percentage of subjects
who have had the procedure, and the number and percentage of subjects who have had all 
follow-up visits will be summarized.
The number and percentage of subjects who are evaluable and the number of subjects who are in 
safety population will be also summarized.
10.3.1.2
Patient Baseline and Characteristics
Demographics (age, sex, and race) of subjects will be summarized. 
A summary on height, weight, and BMI will be also provided. The number and percentage of 
subjects by BMI category (18.5 to < 25; 25 to ≤ 30) will also be provided.
10.3.1.3
Concomitant Therapy 
Concomitant therapy that a patient has during the study will be recorded and summarized.
10.3.1.4
Treatment Compliance 
Treatment compliance will not be applicable in the study.
Efficacy Analyses
10.3.2
The evaluable patient population will be the analysis population used for efficacy.
10.3.2.1
Primary Analyses
The primary endpoint will be CSQ Item #1 measured at Week 12 for subjects who receive 
1 treatment session and at Week 20 for subjects who receive 2 treatment sessions.
Subjects who have reported ‘Very satisfied’ and ‘Satisfied’ will be categorized as ‘Satisfied.’ 
The counts and percentage will be summarized and the 95% CI on the percentage will calculated 
with normal approximation.
10.3.2.2
Secondary Analyses
All secondary endpoints will be measured at Week 12 for subjects who receive 1 treatment
session and at Week 20 for subjects who receive 2 treatment sessions. The analyses on the 
secondary endpoints will include:

Proportion of subjects by treated area(s) (abdomen alone, flanks alone, and both abdomen 
and flanks) with “satisfied” or “very satisfied” on CSQ Item #1.

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Safety Analyses
10.3.3
The safety population will be the analysis population used for safety analyses.
Frequency of AEs including SAEs and ADEs including SADEs will be summarized. 
Subgroup Analyses
10.3.4
Subgroup analysis for the primary and secondary endpoints will be summarized by selected race 
groups. Additional subgroup analyses will be discussed in the study statistical analysis plan.
Interim Analyses
10.3.5
No interim analyses are planned for this study.
10.4 Protocol Deviations
The incidence of major protocol deviations will be summarized for the evaluable population. 
Major protocol deviations will be determined before database lock. Details can be found in the 
statistical analysis plan.

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11 QUALITY ASSURANCE AND QUALITY CONTROL
11.1 Audit and Inspection
Study centers and study documentation may be subject to Quality Assurance audit during the 
course of the study by the sponsor or its nominated representative. In addition, inspections may 
be conducted by regulatory authorities at their discretion.

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12 QUALITY ASSURANCE AND QUALITY CONTROL
12.1 Audit and Inspection
Study centers and study documentation may be subject to Quality Assurance audit during the 
course of the study by the sponsor or its nominated representative. In addition, inspections may 
be conducted by regulatory authorities at their discretion
12.2 Monitoring
Data for each subject will be recorded on a CRF. Data collection must be completed for each 
subject who signs an ICF and is administered study treatment.
In accordance with current GCP and, the study monitor will carry out source document 
verification at regular intervals to ensure that the data collected in the CRF are accurate and 
reliable. 
The investigator must permit the monitor, the independent ethics committee (IEC)/IRB, the 
sponsor’s internal auditors, and representatives from regulatory authority’s direct access to all 
study-related documents and pertinent hospital or medical records for confirmation of data 
contained within the CRFs
12.3 Data Management and Coding
The sponsor or sponsor’s agent will be responsible for activities associated with the data 
management of this study. This will include setting up a relevant database and data transfer 
mechanisms, along with appropriate validation of data and resolution of queries. Data generated 
within this clinical study will be handled according to the relevant standard operating procedures 
of the data management and biostatistics departments of sponsor or agent.
Study centers will enter data directly into an EDC system by completing the CRF via a secure 
internet connection. Data entered into the eCRF must be verifiable against source documents at 
the study center. Data to be recorded directly on the eCRF will be identified and the eCRF will 
be considered the source document. Any changes to the data entered into the EDC system will be 
recorded in the audit trail and will be FDA Code of Federal Regulations 21 Part 11 compliant.
Missing or inconsistent data will be queried in writing to the investigator for clarification. 
Subsequent modifications to the database will be documented.

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13 RECORDS AND SUPPLIES
13.1 Device Accountability
Not applicable.
13.2 Financing and Insurance
Financing and insurance of this study will be outlined in a separate agreement between the 
sponsor and investigator’s site.

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14 ETHICS
14.1 Independent Ethics Committee or Institutional Review Board
Before initiation of the study at each study center, the protocol, the ICF, other written material 
given to the subjects, and any other relevant study documentation will be submitted to the 
appropriate IEC/IRB. Written approval of the study and all relevant study information must be 
obtained before the study center can be initiated. Any necessary extensions or renewals of 
IEC/IRB approval must be obtained for changes to the study such as amendments to the protocol, 
the ICF, or other study documentation. The written approval of the IEC/IRB together with the 
approved ICF must be filed in the study files.
The investigator will report promptly to the IEC/IRB any new information that may adversely 
affect the safety of the subjects or the conduct of the study. The investigator will submit written 
summaries of the study status to the IEC/IRB as required. On completion of the study, the 
IEC/IRB will be notified that the study has ended.
14.2 Regulatory Authorities
Relevant study documentation will be submitted to the regulatory authorities of the participating 
countries, according to local/national requirements, for review and approval before the beginning 
of the study. On completion of the study, the regulatory authorities will be notified that the study 
has ended.
14.3 Ethical Conduct of the Study
The investigator(s) and all parties involved in this study should conduct the study in adherence to 
the ethical principles based on the Declaration of Helsinki, GCP, and the applicable national and 
local laws and regulatory requirements.
14.4 Informed Consent
The process of obtaining informed consent must be in accordance with applicable regulatory 
requirement(s) and must adhere to GCP.
The investigator is responsible for ensuring that no subject undergoes any study-related 
examination or activity before that subject has given written informed consent to participate in 
the study.
The investigator or designated personnel will inform the subject of the objectives, methods, 
anticipated benefits, and potential risks and inconveniences of the study. The subject should be 
given every opportunity to ask for clarification of any points s/he does not understand and, if 
necessary, ask for more information. At the end of the interview, the subject will be given ample 
time to consider the study. Subjects will be required to sign and date the ICF. After signatures 
are obtained, the ICF will be kept and archived by the investigator in the investigator’s study file. 
A signed and dated copy of the subject ICF will be provided to the subject or their authorized 
representative.

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It should be emphasized that the subject may refuse to enter the study or to withdraw from the 
study at any time, without consequences for their further care or penalty or loss of benefits to 
which the subject is otherwise entitled. Subjects who refuse to give or who withdraw written 
informed consent should not be included or continue in the study.
If new information becomes available that may be relevant to the subject’s willingness to 
continue participation in the study, a new ICF will be approved by the IEC(s)/IRB(s). The study 
subjects will be informed about this new information and reconsent will be obtained.
14.5 Subject Confidentiality
Monitors, auditors, and other authorized agents of the sponsor and/or its designee, the 
IEC(s)/IRB(s) approving this research, as well as that of any other applicable agency(ies), will be 
granted direct access to the study subjects’ original medical records for verification of clinical 
study procedures and/or data, without violating the confidentiality of the subjects to the extent 
permitted by the law and regulations. In any presentations of the results of this study or in 
publications, the subjects’ identity will remain confidential.

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15 REPORTING AND PUBLICATION, INCLUDING ARCHIVING
Essential documents are those documents that individually and collectively permit evaluation of 
the study and quality of the data produced. After completion of the study (end of study defined as 
the date of the last visit of the last subject), all documents and data relating to the study will be 
kept in an orderly manner by the investigator in a secure study file. This file will be available for 
inspection by the sponsor or its representatives. Essential documents should be retained for 2 
years after the final marketing approval or for at least 2 years since the discontinuation of clinical 
development of the investigational product. It is the responsibility of the sponsor to inform the 
study center when these documents no longer need to be retained. The investigator must contact 
the sponsor before destroying any study-related documentation. In addition, all subject medical 
records and other source documentation will be kept for the maximum time permitted by the 
hospital, institution, or medical practice.
The sponsor must review and approve any results of the study or abstracts for professional 
meetings prepared by the investigator(s). Published data must not compromise the objectives of 
the study. Data from individual study centers in multicenter studies must not be published 
separately.

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16
REFERENCES
Beacham BE, Cooper PH, Buchanan CS, Weary PE. Equestrian cold panniculitis in 
1.
women. Arch Dermatol 1980;116(9):1025–1027.
Bernstein EF, Bloom, JD, Basilavecchio LD, Plugis J M. Non-invasive fat reduction of the 
2.
flanks using a new cryolipolysis applicator and overlapping, two-cycle treatments. Lasers 
in Surgery and Medicine. 2014; 46(10):731-735. doi:10.1002/lsm.22302.
Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical Efficacy of 
3.
Noninvasive Cryolipolysis and Its Effects on Peripheral Nerves. Aesthetic Plastic Surgery, 
2009;33(4):482-488. doi:10.1007/s00266-008-9286-8.
Dierickx CC, Mazer J, Sand M, Koenig S, Arigon V. Safety, Tolerance, and Patient 
4.
Satisfaction With Noninvasive Cryolipolysis. Dermatologic Surgery, 2013;39(8), 1209-
1216. doi:10.1111/dsu.12238.
Epstein EH, Jr., Oren ME. Popsicle Panniculitis. N Engl J Med 1970;282(17):966–967.
5.
Keaney TC, Gudas AT, Alster TS. Delayed Onset Pain Associated With Cryolipolysis 
6.
Treatment. Dermatologic Surgery, 2015;41(11):1296-1299. 
doi:10.1097/dss.0000000000000502.
Klein KB, Bachelor EP, Becker EV, Bowes LE. Multiple same day cryolipolysis 
7.
treatments for the reduction of subcutaneous fat are safe and do not affect serum lipid 
levels or liver function tests. Lasers in Surgery and Medicine. 2017;49(7), 640-644. 
doi:10.1002/lsm.22674.
Manstein D. Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective 
8.
cryolysis: A Novel Method of Non-Invasive Fat Removal. Lasers Surg Med 2008;40:595-
604.
Shek SY, Chan NP, Chan HH. Non-invasive cryolipolysis for body contouring in Chinese-
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a first commercial experience. Lasers in Surgery and Medicine, 2012;44(2): 125-130. 
doi:10.1002/lsm.21145.
Stevens WG, Pietrzak LK, Spring MA. Broad Overview of a Clinical and Commercial 
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Experience With CoolSculpting. Aesthetic Surgery Journal. 2013;33(6): 835-846. 
doi:10.1177/1090820x13494757.

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17 APPENDICES

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17.1 Investigator Signature Page
Protocol Title:
International CoolSculpting: Prospective, Multi-Country, Study to 
Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in 
Abdomen and/or Flanks
Protocol Number:
CMO-MA-PLS-0602
Confidentiality and Current GCP Compliance Statement
I, the undersigned, have reviewed this protocol (and amendments), including appendices, and I 
will conduct the study as described in compliance with this protocol (and amendments), GCP, 
and relevant regulatory guidelines.
Once the protocol has been approved by the IEC/IRB, I will not modify this protocol without 
obtaining prior approval of Allergan and of the IEC/IRB. I will submit the protocol amendments 
and/or any ICF modifications to Allergan and IEC/IRB, and approval will be obtained before any 
amendments are implemented.
I understand that all information obtained during the conduct of the study with regard to the 
subjects’ state of health will be regarded as confidential. No subjects’ names will be disclosed. 
All subjects will be identified by assigned numbers on all CRFs, laboratory samples, or source 
documents forwarded to the sponsor. Clinical information may be reviewed by the sponsor or its 
agents or regulatory agencies. Agreement must be obtained from the subject before disclosure of 
subject information to a third party.
Information developed in this clinical study may be disclosed by Allergan, to other clinical 
investigators, regulatory agencies, or other health authority or government agencies as required.
Investigator Signature
Date
Printed Name
Institution

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