A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study to Evaluate the Effectiveness and Safety of Restylane Kysse Versus a Control in the Augmentation of Soft Tissue Fullness of the Lip
Phase: NA
Conditions: Lip Augmentation
Sponsor: Galderma R&D



Page 16 of 75
Abbreviations and Definitions of Terms
AE
Adverse event 
BDDE
1,4-butanediol diglycidyl ether
CE
“Conformité  Européenne” the quality and branding mark for products 
made or sold within the European Union.
CFR
Code of Federal Regulations
CIP
Clinical Investigational Plan
Childbearing 
Potential
The ability of a pre-menopausal female to become pregnant. This 
includes women using oral, injectable or barrier contraception; women 
who have had a tubal ligation; women who are single; and women whose 
male partners have been vasectomized or utilize barrier contraceptive 
methods.
CTA
Clinical trial agreement
CTN
Clinical trial number
CV
Curriculum vitae
Device 
deficiency
Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance (includes malfunctions, use 
errors, and inadequate labelling)
DMP
Data management plan
eCRF
Electronic case report form
ET
Early termination
FDA
United States Food and Drug Administration
First subject in
First subject screened, i.e. who signs the informed consent form
First subject out
First subject who completed their last study visit
FST
Fitzpatrick Skin Type
G
Gauge
GCP
Good clinical practice
HA
Hyaluronic acid
HIPAA
Health Insurance Portability and Accountability Act
ICH
International Conference on Harmonization
IFU
Instructions for use
Investigational 
Product
Medical device being assessed for safety or performance in a study. 
“Investigational product” is the same as “study device”, “investigational 
device”, or “investigational medical device”.

Page 17 of 75
Institution
Any public or private entity or agency or medical or dental facility where 
a clinical study is conducted.
Investigator
The Principal Investigator (PI) or other qualified person, i.e. sub-
investigator, designated and supervised by the PI at a study site to 
perform critical study-related procedures or to make important study-
related decisions as specified on the signature and delegation log
Investigator file
Essential documents relating to a clinical study as defined in applicable 
GCP guidance document and maintained by the Investigator.
IRB
Institutional review board
ISO
International Organization for Standardization
ITT
Intention-to-treat
Last subject in
Last subject who entered the study
Last subject out
Last subject who completed their last study visit
MedDRA
Medical dictionary for regulatory activities
NSAID
Non-steroidal anti-inflammatory drugs
PI
Principal Investigator; qualified person responsible for conducting the 
study at a study site
PP
Per protocol
PT
Preferred term
QA
Quality assurance
RA
Regulatory authority
ROPI
Report of Prior Investigations, i.e. compilation of the current clinical and 
non-clinical information on the investigational product, relevant to the 
clinical study
SAE
Serious adverse event
SAP
Statistical Analysis Plan
SDV
Source data verification
SOC
System Organ Class
Sponsor file
Essential documents relating to a clinical study as defined in applicable 
GCP guidance document and maintained by the Sponsor.
Study files
The Investigator file and the Sponsor file
Study products
The investigational product and the reference product under study
Study site
Institution or site where the study is carried out
TC
Telephone Call

Page 18 of 75
Touch-up
Repeated injection to be performed after treatment if necessary to achieve 
optimal correction 
Tx
Treatment
WAS
Wrinkle Assessment Scale
WHO
World Health Organization

Page 19 of 75
Table of Contents
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
2
SIGNED AGREEMENT OF THE CLINICAL INVESTIGATIONAL PLAN
4
SYNOPSIS
5
ABBREVIATIONS AND DEFINITIONS OF TERMS
16
LIST OF TABLES
22
LIST OF FIGURES
22
LIST OF APPENDICES
22
ETHICAL CONSIDERATIONS
23
1.1
Statement of ethical compliance
23
1.2
Application to independent ethics committee and/or regulatory authorities
23
2.
BACKGROUND INFORMATION
23
2.1
Indication and population description
23
2.2
Investigational and comparator product descriptions
23
2.2.1
Clinical documentation
24
2.3
Study rationale
24
2.4
Justification for the design of the study
25
2.5
Risks and benefits
25
3.
OBJECTIVE(S) AND ENDPOINT(S)
26
3.1.1
Primary objective and endpoint
26
3.1.2
Secondary objectives and endpoints
26
3.1.3
Safety objectives and endpoints
27
3.1.4
Exploratory objectives
27
4.
DESIGN OF THE STUDY
27
4.1
General outline
27
4.2
Number of subjects
30
4.3
Duration of subject participation
30
4.4
Randomization and blinding
30
4.4.1
Randomization
30
4.4.2
Blinding
30
4.4.3
Emergency unblinding
30
4.5
Medical history
30
4.6
Concomitant medications, treatments, and procedures
30
4.7
Schedule of events
32

Page 21 of 75
8.
SAFETY ASSESSMENTS
56
8.1
Assessment of AEs by direct question to subject and evaluation of subject
56
8.2
Pre-defined, expected, post-treatment events
56
8.3
Product palpability
57
8.4
Evaluation of lip texture and symmetry
57
8.5
Evaluation of lip movement, function and sensation
57
8.6
Laboratory Assessments
57
8.7
Adverse events
58
8.7.1
Definition of an adverse event
58
8.7.2
Definition of a serious adverse event
58
8.7.3
Recording instructions
58
8.7.4
Reporting of adverse events
60
8.7.5
Reporting of serious adverse events
60
8.7.6
Follow up of ongoing related events after termination of the study and events with onset after termination of 
study (subject last visit)
61
8.7.7
Pregnancy
61
8.7.8
Anticipated adverse events
61
8.8
Device deficiencies
62
8.8.1
Definition of a device deficiency
62
8.8.2
Recording instructions
62
8.8.3
Reporting of device deficiencies
62
9.
DATA HANDLING AND MANAGEMENT
62
9.1
Data management
62
9.2
Electronic case report forms
63
9.2.1
Data entry
63
9.2.2
The query process
64
9.2.3
User identification
64
9.2.4
Audit trail
64
9.3
Source documents
64
9.4
Record keeping and access to source data
64
9.5
Document and data retention
65
10.
STATISTICAL METHODS
65
10.1
General
65
66
10.3
Demographics, baseline assessments, and subject characteristics
66

Page 22 of 75
10.4
Efficacy analysis
66
10.5
Safety analysis
67
10.6
Handling of missing data
67
10.7
Interim analysis
68
10.8
Withdrawals and deviations
68
10.9
Sample size
68
11.
PROTECTION OF PERSONAL DATA
69
12.
QUALITY CONTROL AND QUALITY ASSURANCE
69
12.1
Quality control
69
12.2
Quality assurance
70
12.3
Changes to the clinical study protocol
70
13.
FINANCING, INDEMNIFICATION, AND INSURANCE
70
14.
PUBLICATION POLICY
70
15.
SUSPENSION OR PREMATURE TERMINATION
71
16.
REFERENCES
72
17.
APPENDICES
73
List of Tables
List of Figures
List of Appendices

Page 28 of 75
Investigator blinding will be accomplished by using a Treating Investigator to administer the 
treatments and a Blinded Evaluator, to whom randomization and treatment are concealed, to 
conduct the blinded assessments.  Safety assessments will be performed by non-blinded 
personnel.
Eligible subjects randomized to receive treatment will be injected by the Treating Investigator 
at Day 1.  The method of injection is at the discretion of the Treating Investigator and will be 
recorded.  Sufficient amount of product should be injected to achieve optimal correction of 
the lips, in the opinion of the Treating Investigator and subject.  Optimal appearance is 
defined as at least 1 MLFS step improvement from Baseline and best correction that can be 
achieved as agreed by the Treating Investigator and the subject.  Touch-up treatment may be 
administered after 4 weeks if deemed necessary to obtain optimal aesthetic result; this 
decision should be agreed upon by the Treating Investigator and the subject.  Touch-up 
treatment will not be performed if the subject has a disease or condition described in the 
exclusion criteria, or an ongoing treatment-related AE that in the opinion of the Treating 
Investigator would be worsened by a touch-up.  It is recommended that the dose should not 
exceed 1.5 mL in each lip (including vermillion, vermillion border and cupid’s bow) per 
treatment session. The study product may also be injected for optimal correction of the upper 
perioral rhytids, philtral columns, and/or oral commissures.  The recommended maximum 
injected volume per subject and treatment is 6 mL (i.e. 3 mL for lips and 3 mL for perioral 
area).   
Subjects will have in-clinic follow up visits at 2, 4, 8, 16, 24, 32, 40, and 48 weeks after the 
last injection.    If a touch-up is performed, a second 2-week and 4-week follow-up visits
should be scheduled.  At the 48-week visit after all study procedures for the visit are 
completed, subjects can receive an optional additional treatment if optimal aesthetic 
improvement is not maintained with Restylane® Kysse. If re-treatment is performed, a second 
2-week and 4-week follow-up visits should be scheduled.  In addition to the clinic visits, 
phone visits will also occur as specified in the study flow chart below.
A Study Flow Chart is provided on the next page.

Page 34 of 75
 
  
Effective date:
Effective
 2017-08-17 12:21
4.0
Print date:
 2019-12-11 18:57

Page 43 of 75
4.8.18 Unscheduled Visits
•
When necessary, unscheduled visits could take place (in particular because of an AE 
needing a specific treatment).  Unscheduled visits related to the study should be 
documented and all adverse events captured. 
5. Subjects
5.1
Subject information and informed consent
The Investigator or his/her authorized designee must always use the IRB-approved subject 
information and informed consent form and it must not be changed without prior discussion 
with the Sponsor and approval from the applicable IRB.
It is the responsibility of the Investigator or his/her authorized designee to give each subject 
prior to inclusion in the study, full and adequate verbal and written information regarding all 
aspects of the clinical study that are relevant to the subject’s decision to participate 
throughout the study, e.g. explain the purpose and procedures of the study, the duration and 
number of expected participants, possible risks involved, and the opinion of the IRB.  The 
subject shall be informed that the participation is confidential and voluntary and that the 
subject has the right to withdraw from the study at any time, without any effect on his/her 
future medical care, treatment or benefits to which the subject is otherwise entitled.  The 
information shall be provided in a language clearly and fully understandable to the subject. 
The subject shall be given sufficient time to read and understand the informed consent form 
and to consider participation in the study.  Before any study-related activities are performed, 
the informed consent form shall be personally signed and dated by the subject and the 
Investigator or his/her authorized designee responsible for conducting the informed consent 
process.  
All original signed informed consent forms shall be filed in the Investigator file.  The subject 
shall be provided with a copy of the signed and dated informed consent form and any other 
written information.
The Investigator shall ensure that important new information is provided to new and existing 
subjects throughout the study.
5.2
Inclusion criteria
The subjects must meet the following criteria to be eligible for the study:

Page 58 of 75
8.7
Adverse events
8.7.1 Definition of an adverse event
An AE is any untoward medical occurrence, unintended disease or injury, or untoward 
clinical signs (including abnormal laboratory findings) in subjects, users or other persons1, 
whether or not related to the study product. 
This definition includes:
a) events related to the investigational product or the reference product
b) events related to the procedures involved
8.7.2 Definition of a serious adverse event
A serious adverse event (SAE) is an AE that:
a) led to death,
b) led to serious deterioration in the health of the subject, that either resulted in
1. a life-threatening2 illness or injury, or
2. a permanent impairment of a body structure or body function, or
3. in-patient or prolonged hospitalization3, or
4. medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
c) led to fetal distress, fetal death, or a congenital abnormality or birth defect
An AE does not need to be recorded as a SAE if it only represents a relapse or an expected 
change or progression of the condition that was the cause of the treatment, without the 
development of new symptoms and signs.
In cases of doubt, whether an AE fulfils a serious criterion or not, there should be a 
predisposition to report as a SAE rather than not report as such
8.7.3 Recording instructions
Each subject with an AE occurring after signing of the informed consent form through 
study exit should be fully recorded in the source document for further transcription to the 
eCRF.  Each subject should be questioned about AEs at each study visit following the 
screening visit. The question asked should be: “Since your last clinical visit have you had 
any health problems?” Information on AEs can also be obtained from signs and symptoms 
detected during each examination.  
                                                
1For users or other persons, this definition is restricted to events related to the investigational product.
2The term “life-threatening” in the definition of “serious” refers to an event in which the patient was at risk of 
death at the time of the event; it does not refer to an event which hypothetically might have caused death if it 
were more severe. (Source: ICH-E2A clinical safety data management: definitions and standards for expedited 
reporting).
3Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without serious 
deterioration in health, is not considered a SAE. (Source: ISO14155:2011).

Page 59 of 75
When an AE is related to a device deficiency including technical device malfunction, the 
AE should be recorded in the AE eCRF and technical complaint should be reported 
separately on the study complaint form.  
Investigators, or other study site personnel, shall record all AEs in the eCRF, including:
a) Event term (recorded in standard medical terminology and avoiding abbreviations)
b) Description of event and affected area 
c) Start date (first day with symptoms)
d) Stop date (last day with symptoms)
e) Intensity (mild, moderate, or severe according to definition in Section 8.5.3.1)
f)
Seriousness (serious or not serious, according to definition in Section 8.5.3.2)
g) Causal relationship to study product or study product injection procedure (yes or no)
h) Action taken (none, medication treatment, non-medication treatment, or other 
procedures/tests, subject withdrawn)
i)
Outcome of the AE (ongoing, recovered, recovered with sequelae, death, chronic/ 
stable, not recovered at the end of the study)
The pre-defined, expected post-treatment events shall be assessed separately. These events 
shall be collected by subjects in a diary used daily for 30 days after the treatment.
8.7.3.1 Intensity
Intensity will be recorded for each reported AE. The following definitions of intensity are to 
be used:
Mild:
Awareness of symptoms or signs, but easily tolerated (acceptable)
Moderate:
Enough discomfort to interfere with usual activity (disturbing) 
Severe:
Incapacity to work or to do usual activity (unacceptable) 
If the intensity changes within one day, the maximum intensity of the AE during that day 
shall be recorded.
8.7.3.2 Causal relationship and seriousness
Each AE, serious as well as non-serious, shall be assessed by the Investigator for causal 
relationship with the study product and its use (the injection procedure) and for seriousness
(Yes or No) of the event. 
A two-point scale (Yes or No response) shall be used for the causality assessments. The 
Investigators shall be asked to indicate a response to each of the following questions in the 
eCRF:

“Do you consider that there is a reasonable possibility that the event may have been 
caused by the study product?”, and 

“Do you consider that there is a reasonable possibility that the event may have been 
caused by the device injection procedure?”
If any of these questions is answered ‘Yes’, the AE is considered related.

Page 63 of 75
management, data entry and verification, data validation, and documentation of the 
performed activities including information of discrepancies in the process. The data 
management process will be described in detail in the data management plan (DMP).
The database, the data entry screens and program will be designed in accordance with the CIP 
and the eCRF. Data validation will be performed by computerized logical checks and manual 
review. Drugs and events will be coded in accordance with World Health Organization 
(WHO) Drug and medical dictionary for regulatory activities (MedDRA) dictionaries as 
specified in the DMP. SAEs in the clinical database will be reconciled against the data in the 
safety database.
When all efforts have been made to ensure that the data recorded in the eCRFs and entered in 
the database is as correct and complete as possible, the clinical database will be locked. Study 
data will be transferred to SAS datasets which thereafter will be write-protected. Statistical 
analyses will be generated in SAS using data from the locked datasets.
9.2
Electronic case report forms
A 21 Code of Federal Regulations Part 11-compliant electronic data capture application will 
be used to collect, modify, maintain, archive, retrieve, and transmit study data.  An eCRF is 
required and shall be completed electronically for each screen failure as well as enrolled 
subjects. 
The eCRF includes password protection and internal quality checks, such as automatic range 
checks, to identify data that appear inconsistent, incomplete, or inaccurate.  Study data shall 
be entered directly from the source documents, which are to be defined at each site before 
inclusion of the first subject.
Authorized study site personnel designated by the Investigator shall complete data collection. 
Appropriate training and security measures shall be completed with all authorized 
investigation site personnel prior to the study being initiated and any data being entered into 
the system for any subject.
The study data is the sole property of the Sponsor and shall not be made available in any form 
to third parties, except for authorized representatives of appropriate RA, without written 
permission from the Sponsor.  At the end of the study, electronic data are kept at the Sponsor 
and a copy (provided by the vendor) at the study site as part of the Investigator file.
Any delegation of collection of data shall be specified in a signature and delegation log.
9.2.1 Data entry
All data shall be entered in English. The eCRFs should always reflect the latest 
observations on the subjects participating in the study. Therefore, the eCRFs shall be 
completed as soon as possible during or after the subject’s visit. The subject’s identity must 
always remain confidential, i.e. the name and address of the subjects must not be registered 
in the eCRFs or in the database. The Investigator must verify that all data entries in the 
eCRFs are accurate and correct. If some assessments are not done, or if certain information 
is not available, not applicable or unknown, the Investigator shall indicate this in the eCRF. 
The Investigator shall electronically sign off the study data. By signing, the Investigator 
takes responsibility for the accuracy, completeness, and legibility of the data reported to the 
Sponsor in the eCRF. 

Page 64 of 75
9.2.2 The query process
The monitor shall review the eCRFs and evaluate them for completeness and consistency. 
Each eCRF shall be compared with the respective source documents to ensure that there are 
no discrepancies between critical data. All entries, corrections, and alterations shall be 
made by the PI or his/her authorized designee. The monitor cannot enter data in the eCRFs. 
Once study data have been submitted to the central server via the eCRF, corrections to the 
data fields will be audit trailed, meaning that the reason for change, the name of the person 
who made the change, together with time and date will be logged. Roles and rights of the 
site personnel responsible for entering study data into the eCRF shall be determined in 
advance. If discrepant data is detected during review of the data, either by the Sponsor or its 
representatives, the responsible data manager or monitor shall raise a query in the electronic 
data capture application. The query shall state the question or data to be changed and shall 
be resolved in the system by the PI or his/her authorized designee. The appropriate study 
site personnel shall answer the queries in the eCRF. This will be audit trailed by the 
electronic data capture application meaning that the name of study site personnel, time, and 
date is logged.
9.2.3 User identification
eCRF records will be automatically appended with the identification of the creator, by 
means of their unique User ID. Specified records shall be electronically signed by the 
Investigator to document his/her review of the data and acknowledgement that the data are 
accurate. This will be facilitated by means of the Investigator’s unique User ID and 
password; date and time stamps will be added automatically at time of electronic signature. 
If an entry in an eCRF requires change, the correction shall be made in accordance with the 
relevant software procedures. 
9.2.4 Audit trail
All changes will be fully recorded in a protected audit trail and a reason for the change shall 
be stated. Once all data have been entered, verified, and validated, the database will be 
locked.
9.3
Source documents
Source documents are all documents used by the Investigator or hospital that relate to the 
subject’s medical history, that verifies the existence of the subject, the inclusion and 
exclusion criteria, and all records covering the subject’s participation in the study.  They 
include laboratory notes, memoranda, material dispensing records, subject files, etc.
The Investigator is responsible for maintaining source documents.  These shall be made 
available for inspection by the monitor at each monitoring visit.  The Investigator must 
submit a completed eCRF for each subject for whom signed informed consent has been 
collected.  All supportive documentation submitted with the eCRF, such as laboratory or 
hospital records, shall be clearly identified with the CTN and subject number. Any personal 
information, including name, shall be removed or rendered illegible to preserve individual 
confidentiality.
9.4
Record keeping and access to source data
The Investigator/Institution shall permit study-related monitoring, audits, IRB review, and 
RA inspections and shall provide direct access to the source data/medical record including 

Page 70 of 75
12.2 Quality assurance
The study site may be subject to quality assurance audit by the Sponsor as well as inspection 
by appropriate RA.  It is important that the Investigator and other relevant study site 
personnel are available during the monitoring visits, possible audits, and inspections, and that 
sufficient time is devoted to the monitoring process.
Each participating member of the study site team shall provide a curriculum vitae (CV) or 
equivalent that demonstrates their qualifications to conduct the study.  
It is the responsibility of the Investigator to ensure that all personnel involved in the study are 
fully informed of all relevant aspects of the study, including detailed knowledge of and 
training in all procedures to be followed.  All Investigators and other responsible persons 
shall be listed together with their function in the study on a signature and delegation log.
12.3 Changes to the clinical study protocol
The Investigator and other site personnel involved in the study must not implement any 
deviation from or changes to the CIP without agreement with the Sponsor and prior review 
and documented approval from the IRB, except where necessary to eliminate an immediate 
hazard to the subjects. All changes to the final CIP must be documented in a written protocol 
amendment.  However, administrative changes are to be documented in the Sponsor file 
without requiring a protocol amendment.  The Sponsor will assess if the changes require prior 
FDA approval, and inform the Investigator when such approval has been received.
13. Financing, Indemnification, and Insurance
The CTA outlines the compensation and payment terms of the study.  The CTA must be 
signed before the first subject is screened in the study.  If there are differences between the 
CTA and the CIP regarding certain rights and obligations, the CTA is the prevailing
document.
The Sponsor’s obligations in this clinical study are covered by Galderma’s global general 
liability program.
An
insurance
certificate
will
be
provided
upon
request.  The
Institution/Investigator is obligated to maintain insurance coverage for their obligations in
the clinical study according to the CTA.
14. Publication Policy
The Investigator’s, Institution’s, and Sponsor’s obligations regarding intellectual property 
rights, confidentiality, and publications are described in detail in the CTA.
This study will be displayed on clinicaltrials.gov in accordance with local regulations.  The
aim is to submit the results of this study for publication.  Everyone who is to be listed as an 
author 
of 
the 
publication 
shall 
have 
made 
a 
substantial, 
direct, 
intellectual 
contribution to the work.  Authorship will be based on (1) substantial contributions to the 
conception or design of the work; or the acquisition, analysis, or interpretation of data for
the work; and (2) drafting the work or revising it critically for important intellectual content;
and (3) final approval of the version to be published; and (4) agreement to be accountable for 
all aspects of the work in ensuring that questions related to the accuracy or integrity of any 

Page 71 of 75
part of the work are appropriately investigated and resolved1.  Conditions 1, 2, 3, and 4 must
all be met in order to be designated as author. Those who do not meet all four criteria will
be acknowledged.  Among the authors that fulfil the above mentioned criteria, one author
will be appointed by Q-Med AB to take primary responsibility for the overall work as 
primary author.
15. Suspension or Premature Termination
The Sponsor will suspend or terminate the study when so instructed by the IRB or FDA, or if
it is judged that the subjects are subjected to unreasonable risks, or for valid scientific or 
administrative reasons.
The Sponsor may also decide to close a single study site due to unsatisfactory subject
enrollment or non-compliance with the CIP, GCP, or applicable regulatory requirements.
In the event of premature termination, the Sponsor will provide information on the handling
of currently enrolled subjects who have not completed the study.
                                                
1Defining the role of authors and contributors, compiled by the International Committee of Medical 
Journal Editors (ICMJE) (http://www.icmje.org).

Page 72 of 75
16. References
1. https://www.verywell.com/fitzpatrick-classification-scale-1069226
2. Alam M, Gladstone H, Kramer EM, et al.  ASDA guidelines of care: injectable fillers.  
Dermatol Surg.  2008; 34 (suppl 1): S115-S148.
3. Carruthers J, Fagien S, Dolman P. Retro or PeriBulbar Injection Techniques to 
Reverse Visual Loss After Filler Injections. Dermatol Surg. 2015 Dec; 41 Suppl 
1:S354-7.
4. Cohen JL, Biesman BS, Dayan SH, et al. Treatment of Hyaluronic Acid Filler-
Induced Impending Necrosis With Hyaluronidase: Consensus Recommendations. 
Aesthet Surg J. 2015 Sep; 35 (7):844-9.
5. Fitzpatrick T.B. (1988). The validity and practicality of sun-reactive skin types I 
through VI. Arch. Dermatol. 124, 869 871.
6. Kane MA, Lorenc ZP, Lin X, Smith SR. Validation of a lip fullness scale for 
assessment of lip augmentation. PlastReconstrSurg. 2012;129(5):822e-8e
7. Lemperle, G. A Classification of Facial Wrinkles. Plastic Reconstructive Surgery. 
2001:1735-1750.
8. Restylane® Silk (SPHAL study) PMA P040024/S072.
9. Signorini M, Liew S, Sundaram H, et al. Global Aesthetics Consensus Group. Global 
Aesthetics Consensus: Avoidance and Management of Complications from 
Hyaluronic Acid Fillers-Evidence- and Opinion-Based Review and Consensus 
Recommendations. Plast Reconstr Surg. 2016 Jun; 137(6):961e-71e.

Page 73 of 75
17. Appendices