Assess the Impact of Lip Rejuvenation With Restylane® Silk on Projected First Impressions and Mood Perceptions
Phase: NA
Conditions: Lip Rejuvenation
Sponsor: DeNova Research

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STUDY PROTOCOL 
 
PROTOCOL TITLE: 
An Open-Label, Post-Market Study to Assess the Impact of 
Lip Rejuvenation with Restylane® Silk on Projected 
First Impressions and Mood Perceptions 
 
COSMECEUTICAL: 
Restylane® Silk 
SPONSOR: 
Steven H. Dayan, M.D., F.A.C.S. 
845 N. Michigan Avenue, Suite 
923E Chicago, IL 60611 
Telephone: (312) 335-2070 
Fax: (312) 335-2074 
 
INVESTIGATOR: 
Steven H. Dayan, M.D., F.A.C.S. 
845 N. Michigan Avenue, Suite 
923E Chicago, IL 60611 
Telephone: (312) 335-2070 
Fax: (312) 335-2074 
 
PROTOCOL NUMBER: 
Silk-FI-01 
 
NCT NUMBER: 
03241862  
 
PROTOCOL VERSION DATE: Version 2, 11 June 2015 
 
PROTOCOL AUTHOR: 
Nazanin Ashourian, Ph.D. 
 
INVESTIGATION SITE: 
DeNova Research 
845 N. Michigan Avenue, Suite 
923E Chicago, IL 60611 
Telephone: (312) 335-2070 
Fax: (312) 335-2074 
 

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CONFIDENTIALITY 
STATEMENT 
This study is confidential in nature. All information related to this study is considered proprietary and should not be made 
available to those not directly involved in this study. Authorized recipients of this information include investigators and co- 
investigators, other health care personnel necessary to conduct the study and institutional review boards. The above personnel 

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INVESTIGATOR AGREEMENT 
 
I have read the foregoing protocol and agree that it contains all necessary details for carrying out 
this study. I will conduct the study as outlined herein and will complete the study within the time 
designated. 
 
I will comply with Good Clinical Practice (GCP) regulations and guidelines during the 
conduct of this study. I certify that this study will be conducted in accordance with the ethical 
principles that have their origin in the Declaration of Helsinki and that they are consistent 
with Good Clinical Practice and applicable regulatory requirements. The study must be 
conducted in accordance with the regulations of the United States Food and Drug 
Administration (FDA) as described in 21 CFR 50 and 812, applicable laws, and the IRB 
requirements. 
 
I will provide copies of the protocol and all pertinent information to all individuals responsible 
to me who assist in the conduct of this study. I will discuss this material with them to ensure 
they are fully informed regarding the treatment and the conduct of the study. 
 
I will use only the informed consent form approved by the Institutional Review Board (IRB) or 
Ethics Committee (EC) and will fulfill all responsibilities for submitting pertinent information 
especially with respect to development of any serious adverse events to the Institutional Review 
Board or Ethics Committee responsible for this study. 
 
 
Principal Investigator: 
 
 
Steven H. Dayan 
Printed Name 
Signature 
Date 
 
 
845 N. Michigan Ave, Suite 923E Chicago, IL 60611 
Address 

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TABLE OF CONTENTS 
INVESTIGATOR AGREEMENT .................................................................... 2 
LIST OF APPENDICES ........................................................................ 4 
1 
LIST OF ABBREVIATIONS .............................................................. 5 
2 
PROTOCOL SYNOPSIS ......................................................................... 6 
3 
INVESTIGATOR ................................................................................... 8 
4 
BACKGROUND ..................................................................................... 8 
5 
STUDY OBJECTIVES .......................................................................... 8 
6 
STUDY DESIGN .................................................................................... 9 
7 
SUBJECT SELECTION ........................................................................... 9 
7.1 
Inclusion Criteria ..................................................................................... 10 
7.2 
Exclusion Criteria .................................................................................... 10 
8 
TREATMENT AND STUDY SUPPLIES .................................................... 10 
8.1 
Description of Study Supplies and Handling .................................................. 10 
8.2 
Packaging and Labeling ................................................................................... 11 
8.3 
Method of Application ............................................................................... 11 
8.3.1 
Pre-treatment Guidelines .............................................................................................................. 11 
8.3.2 
Treatment Procedure .................................................................................................................... 11 
8.3.3 
Injection Technique ....................................................................................................................... 11 
9 
STUDY PROCEDURES ......................................................................... 11 
9.1 
Visit 1: Screening Assessments ........................................................................ 11 
9.2 
Visit 2: Treatment .......................................................................................... 12 
9.3 
Visit 3: OCR Evaluation ............................................................................. 12 
9.4 
Visit 4: 14-Day Post-OCR .......................................................................... 13 
9.5 
Post-Visit Evaluations ............................................................................... 13 
10 RESPONSE CRITERIA ................................................................. 13 
10.1 
Primary Variable Assessments ........................................................................ 13 
10.1.1 
Assessment of First Impressions .................................................................................................. 13 
10.1.2 
Subjective Happiness Scale (SHS) Evaluation ............................................................................... 14 
10.1.3 
The Happiness Measures (HM) Evaluation .................................................................................. 14 
10.2 
Secondary Variable Assessments .................................................................... 14 
10.2.1 
Subject Global Aesthetic Improvement Scale (S-GAIS) Evaluation................................................. 14 
10.2.2 
PI Global Aesthetic Improvement Scale (PI-GAIS) Evaluation ....................................................... 14 
10.2.3 
Oral Commissure Severity Scale (OCSS) Evaluation ...................................................................... 14 
10.2.4 
Perioral Lines Severity Scale (POLSS) at Rest Evaluation ............................................................... 15 
11 
DATA MANAGEMENTS ...................................................................... 15 
11.1 
Case Report Forms........................................................................................ 15 
11.2 
Data Handling ....................................................................................... 15 
11.3 
Publication ................................................................................................... 15 
12 
STATISTICAL METHODS ................................................................... 16 

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12.1 
Sample Size ................................................................................................. 16 
12.2 
Study Population .......................................................................................... 16 
12.3 
Study Endpoints ........................................................................................... 16 
12.3.1 
Primary Endpoints ....................................................................................................................... 16 
12.3.2 
Secondary Endpoints ................................................................................................................... 16 
12.4 
Methods of Analysis ................................................................................ 16 
13 
ADVERSE EVENTS............................................................................. 16 
13.1 
Definition ............................................................................................. 16 
13.2 
Recording of Adverse Events .......................................................................... 17 
13.3 
Serious Adverse Events and Unanticipated Adverse Device Effects ........................ 17 
13.3.1 
Definition..................................................................................................................................... 17 
13.3.2 
Serious Adverse Events Recording and Reporting ........................................................................ 17 
14 
QUALITY ASSURANCE ...................................................................... 18 
14.1 
Institutional Review Board Approval .......................................................... 18 
14.2 
Informed Consent ......................................................................................... 18 
14.3 
Study Monitoring .......................................................................................... 18 
14.4 
Modification of Protocol ........................................................................... 19 
14.5 
Departure from the Protocol ........................................................................... 19 
14.6 
Confidentiality of Subject Records ............................................................. 19 
14.7 
Record Retention .......................................................................................... 19 
14.8 
Additional Principal Investigator Responsibilities .......................................... 20 
15 
APPENDICES .................................................................................... 21 
16 
REFERENCES .................................................................................... 31 
 
 
 
LIST OF APPENDICES 
 
Appendix A Schedule of Events ............................................................................ 21 
Appendix B Subjective Happiness Scale (SHS) ............................................................. 22 
Appendix C The Happiness Measures (HM) ................................................... 23 
Appendix D Subject Global Aesthetic Improvement Scale (S-GAIS) ....................... 24 
Appendix E PI Global Aesthetic Improvement Scale (PI-GAIS) ......................... 25 
Appendix F First Impressions Questionnaire (FIQ) ............................................... 26 
Appendix G Oral Commissure Severity Scale (OCSS) ........................................... 28 
Appendix H Perioral Line Severity Scale (POLSS) at Rest................................. 29 
Appendix I Standard Operating Protocol for Photo- and Videography ...................... 30 

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1 
LIST OF ABBREVIATIONS 
 
 
 
Abbreviation 
Description 
AE 
Adverse Event 
CFR 
Code of Federal Regulation 
CRF 
Case Report Form 
EC 
Ethics Committee 
FDA 
Food and Drug Administration 
FIQ 
First Impression Questionnaire 
GAIS 
Global Aesthetic Improvement Scale 
GCP 
Good Clinical Practice 
HIPAA 
Health Information Portability and Accountability Act 
HM 
Happiness Measures 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
m 
Meter 
mg 
Milligram 
ml 
Milliliter 
OCR 
Optimal Cosmetic Results 
OCSS 
Oral Commissure Severity Scale 
PI 
Principal Investigator 
POLSS 
Perioral Lines Severity Scale 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SHS 
Subjective Happiness Scale 
SOP 
Standard Operating Protocol 

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2 
PROTOCOL SYNOPSIS 
 
 
Title 
An Open-Label, Post-Market Study to Assess the Impact of 
Lip Rejuvenation with Restylane® Silk on Projected First 
Impressions and Mood Perceptions 
Indication 
Subjects with mild to severe oral commissures or none to severe 
perioral lines who request lip rejuvenation with Restylane® Silk 
Sample Size 
20 
Number of Centers One center in the United States 
Study Objectives 
The primary objective of this study is to determine if subjects 
who receive lip rejuvenation treatment with Restylane® Silk 
project a more positive first impression and report an 
improvement in mood perception. 
Subject Selection 
A total of 20 subjects who wish to receive lip rejuvenation 
treatment with Restylane® Silk and meet the specified criteria will 
be enrolled. 
Study Design 
20 subjects with mild to severe oral commissures or none to severe 
perioral lines will be enrolled and injected with Restylane® Silk. 
Photographs will be taken prior to and 14 days after Optimal 
Cosmetic Results has been achieved, as judged by the investigator. 
Changes in the projected first impression will be assessed by a total 
of 200 blinded evaluators rating the photographs of subjects from the 
baseline and from 14 days post achieving the Optimal Cosmetic 
Results. Changes in subjects’ mood will be self-assessed through 
Subjective Happiness Scale and Happiness Measures questionnaires. 
Aesthetic alterations will be assessed by the investigator via the 
Global Aesthetic Improvement Scale, Oral Commissure Severity 
Scale, and the Perioral Lines Severity Scale as well as by the self- 
assessment of subjects using the Global Aesthetic Improvement 
Scale. 
A schematic of the study design is presented in Appendix A. 

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Study Duration 
Subjects will be followed for 14 days after a treatment that 
has produced Optimal Cosmetic Results. 
Clinical Hypothesis 
Subjects who are treated with Restylane® Silk for lip rejuvenation 
project a more positive first impression as compared to their pre- 
treatment baseline. Those who are treated with Restylane® Silk will 
also report a more positive mood perception after treatment as 
compared to pre-treatment. 

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3 
INVESTIGATOR 
Steven H. Dayan, M.D., 
F.A.C.S. 845 N. Michigan Avenue, 
Suite 923E Chicago, IL 60611 
Telephone: (312) 335-2070 
Fax: (312) 335-2074 
 
4 
BACKGROUND 
A first impression can be defined as the initial judgment made of a person without a prior 
familiarity. It has been well recognized that these zero-acquaintance impressions, which are 
formed within seconds of seeing a person, are greatly influenced by physical appearances1-3. The 
perceived impression forms an image of personality, known as the physical personality, that 
induces a set of expectations and behaviors in others, which, in turn, impact the manner by 
which an individual is judged and treated in the society. 
 
It has been suggested that ‘attractive’ individuals receive better judgments and treatments4 
whereas those deemed ‘unattractive’ generally seem to elicit negative responses5. Various clinical 
studies have also linked aesthetic enhancements, through surgical or non-surgical 
procedures, with improved projected first impressions6-8. Remarkably, the self-perception of 
physical appearances also seems to affect the development of inherent personality. It has been 
elucidated that self-dissatisfaction due to craniofacial abnormalities can elicit low self-esteem5 
while non-surgical aesthetic enhancements may improve self-esteem and lead to a better quality 
of life9. Thus, improvements of physical appearances can create a better projected first 
impression as well as a better self-satisfaction. 
 
In the past decade, dermal fillers have become one of the most popular minimally invasive 
treatments for rejuvenation and body sculpturing. According to the American Society of Plastic 
Surgeons, over 1.6 million hyaluronic acid filler procedures were performed in 201310. 
Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is 
approved by the FDA for submucosal implantation for lip augmentation and dermal implantation 
for correction of perioral rhytids. The goal of this study is to determine if lip rejuvenation of 
patients with mild to severe oral commissures or none to severe perioral lines using Restylane® 
Silk would lead to an improved projected first impression and self-perception of mood. 
 
5 
STUDY OBJECTIVES 
The primary objective of this study is to determine if lip rejuvenation with Restylane® Silk 
results in an improved projected first impression as well as an improved self-perception of 
mood. 
 
The secondary objective is to evaluate aesthetic improvements after lip rejuvenation treatment 
with Restylane® Silk and assess relations to any alternations in the projected first impression 

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and mood perception. 

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6 
STUDY DESIGN 
This is an open-label, post-market study to assess the impact of lip rejuvenation with 
Restylane® Silk on the projected first impression and the self-perception of mood. 
 
20 subjects, at least 21 years of age, who display mild to severe oral commissures or none to 
severe perioral lines, as judged by the Principal Investigator (PI) utilizing the Oral 
Commissure Severity Scale (OCSS, Appendix G) or the Perioral Lines Severity Scale 
(POLSS, Appendix H), will be enrolled. 
 
The study is composed of up to 4 patient visits and a post-visit evaluation of patients’ 
photographs by blinded evaluators. A schematic of the study design is presented in Appendix A. 
 
All subjects who meet the specified criteria, listed in Section 7, will complete the Subjective 
Happiness Scale11,12 (SHS, Appendix B) and the Happiness Measures questionnaire13 (HM, 
Appendix C) prior to receiving any treatments. The PI also records the severity of subjects’ oral 
commissures and/or the perioral lines using the OCSS and/or the POLSS respectively. 
Furthermore, all subjects undergo photo- and videography, as described in Appendix I, prior to 
treatment. 
 
Subjects will then be injected with Restylane® Silk with a volume sufficient to achieve Optimal 
Cosmetic Results (OCR), per treating investigator’s discretion but not to exceed a total of 4 ml (4 syringes). 
Subjects will be assessed 14 ± 3 days after injection for achieving the OCR. If OCR has not 
been reached, as judged by the PI, a second, ‘touch-up,’ injection of Restylane® Silk will be 
performed. 
 
The final evaluation of subjects will take place 14 ± 3 days after achieving OCR. Hence, this 
would be 14 ± 3 days after the first injection for those who achieved OCR with one treatment 
but 28 ± 3 days after the first injection for those who required a ‘touch-up’ injection. Subjects will 
complete the SHS and HM questionnaires as well as self-report any aesthetic alterations 
experienced using the Global Aesthetic Improvement Scale (GAIS, Appendix D). They will 
also undergo photo- and videography, as described in Appendix I. Furthermore, the PI will 
rate the subjects on the GAIS (Appendix E) as well as on the OCSS and the POLSS. 
 
Photographs taken at pre-treatment and 14-Day Post-OCR will be randomly divided into 4 
binders, for a total of 10 photographs per binder. Each binder will be evaluated at least by 
50 blinded evaluators using the First Impressions Questionnaire (FIQ, Appendix F) to rate 
each photograph. 
 
7 
SUBJECT SELECTION 
A total of 20 subjects who meet all of following inclusion criteria and none of the 
exclusion criteria will be enrolled in this study. 

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7.1 
Inclusion Criteria 
All subjects must meet the following inclusion criteria: 
 
1. Subject is an adult of at least 21 years of age; 
2. Subject has mild to severe oral commissures or none to severe perioral lines, as 
assessed by the treating investigator; 
3. Subject is willing and able to provide written informed consent prior to the 
performance of any study related procedure; 
4. Subject is willing and able to comply with the protocol requirements; and 
5. Subject is willing and able to provide written photo consent and adhere to 
the photography and video procedures such as removal of jewelry and 
makeup. 
 
7.2 
Exclusion Criteria 
Subjects meeting any of the following criteria will be excluded from the study: 
 
1. Subjects who have received lip filler treatments in the past 12 months or 
neurotoxin injections in the past 6 months; 
2. Subjects who plan to undergo neurotoxin treatments, ablative skin treatments, 
facial cosmetic surgery, or other injectable filler treatments during the course of the 
study; 
3. Subjects with a known allergy or sensitivity to any component of the study ingredients; 
4. Subjects with a history of bleeding disorders; 
5. Female subjects who are pregnant or nursing as well as those who are of 
childbearing potential but do not employ adequate birth control methods; 
6. Subjects with severe allergies manifested by a history of anaphylaxis or presence of 
multiple severe allergies; 
7. Subjects with previous history of sensitivity to amide type local anesthetics; 
8. Current history of chronic drug or alcohol abuse; 
9. Concurrent therapy that, in the investigator’s opinion, would interfere with the evaluation of the 
safety or efficacy of the study product; 
10. Subjects who, in the investigator’s opinion, have a history of poor cooperation, non- compliance 
with medical treatment, or unreliability; and 
11. Enrollment in any active study involving the use of investigational devices or drugs. 
 
8 
TREATMENT AND STUDY SUPPLIES 
 
8.1 
Description of Study Supplies and Handling 
Restylane® Silk (Galderma Laboratories, L.P.) is a gel of hyaluronic acid produced by the 
Streptococcus species of gram-positive bacteria that is chemically crosslinked with butanediol 
diglycidyl ether (BDDE) and suspended in phosphate buffered saline (pH 7) at a concentration 
of 20 mg/ml with 0.3% lidocaine. Restylane® Silk supplies are stored in a secure cabinet at 
room temperature at the investigation site. 

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8.2 
Packaging and Labeling 
Restylane® Silk is supplied in disposable glass syringes with a Luer-Lok® fitting and is co- 
packed with a sterilized 30 G x ½ needle. Each syringe contains 1 ml of the injectable gel (20 
mg/ml of hyaluronic acid) with 0.3% lidocaine. Each package is for single patient use. A 
patient record label, which is included in the syringe label, will be attached to each patient’s records for product 
traceability. 
 
8.3 
Method of Application 
8.3.1 
Pre-treatment Guidelines 
Prior to treatment, the patient is advised to avoid taking aspirin, nonsteroidal anti-inflammatory 
medications, St. John’s Wort, and high doses of vitamin E supplements 14 days prior to the day of 
treatment, as these agents may increase bruising and bleeding at the injection site. 
8.3.2 
Treatment Procedure 
   The patient’s face is washed with soap and water and dried with a clean towel. The treatment 
area is cleansed with alcohol or Benzalkonium Chloride. 
   Topical anesthetic (30% lodocaine) is applied to the injection area. Alternatively, at 
patient’s request, an infraorbital/mental nerve block with 3% mepivacaine is used to anesthetize 
the treatment area. 
   Restylane® Silk is administered using a thin gauge needle (30 G x ½) or a 22 gauge 
cannula. The needle is inserted at an approximate angle of 30° parallel to the length of 
the wrinkle, fold, or lip. For rhytids, Restylane® Silk is injected into the mid-to-deep 
dermis. 
   A maximum dose of 4.0 ml is used per treatment. 
8.3.3 
Injection Technique 
Restylane® Silk may be injected by a number of different techniques depending on the treating 
physician’s experience and preference as well as the specific characteristics and needs of each patient 
(Restylane® Silk Package Insert14). The appropriate injection method will be employed per 
treating investigator’s discretion. 
 
9 
STUDY PROCEDURES 
 
9.1 
Visit 1: Screening Assessments 
The PI and/or designee is responsible for keeping a record of all subjects screened for entry 
into the study as well those who did not meet the criteria, as described in Section 7, and hence 
were excluded. 
 
The following procedures will be performed: 
 
1. The PI or designee evaluates and confirms that the subject fulfills all 
the inclusion/exclusion criteria, as described in Section 7. 

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2. A written informed consent, signed by the subject as well as by the investigator 
or designee, is obtained. 
3. Demographic information and medical history are obtained. 
4. List of concomitant medications is collected. 
5. Vital signs (blood pressure and pulse rate) are measured. 
6. If the subject is a female of child bearing potential, a urine collection for in-
clinic pregnancy test will be conducted. 
7. Subject completes the SHS questionnaire 
8. Subject completes the HM questionnaire. 
9. Subject undergoes standardized digital photography and video of full face in accordance 
with the site’s SOP (described in Appendix I). 
 
9.2 
Visit 2: Treatment 
Visit 2 will take place no later than 14 days after the screening assessments. If the period 
between the screening assessments and the treatment is greater than 14 days, the in-clinic urine 
pregnancy test will be repeated for females of childbearing potential. The following procedures 
will be performed: 
 
1. Subject’s medical history and concomitant medications are reviewed for changes since Visit 
1, Screening Assessments. 
2. PI rates the subject on the OCSS and POLSS at rest. 
3. The injection area is wiped with a Benzalkonium Chloride towelette. 
4. A topical anesthetic containing 30% lidocaine is applied to the injection areas. 
Alternatively, subject may choose to receive a nerve block, infraorbital/mental with 
3% mepivacaine, to numb the treatment area. 
5. Subject is injected with Restylane® Silk with a volume sufficient to deliver satisfactory 
cosmetic results per treating investigator’s discretion but not to exceed a total of 4 ml (4 syringes). 
6. The volume injected is recorded. 
7. The subject is monitored for any Adverse Events (AEs) 
 
9.3 
Visit 3: OCR Evaluation 
The following procedures will be performed 14 ± 3 days after Visit 2, Treatment: 
 
1. PI assesses the subject for achieving the OCR. 
2. At PI’s discretion, subject may receive a touch-up treatment in order to achieve OCR (not to 
exceed a total dose of 4 ml of Restylane® Silk). 
3. A report of any AEs and changes in concomitant medications is obtained from the 
subject. 
 
Subjects who require a touch-up injection will be instructed to return for the forth and final 
visit in 14 ± 3 days. For those who have achieved OCR, and hence do not require a touch-
up injection, the following procedures will be performed: 
 
1. Subject completes the SHS questionnaire. 

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2. Subject completes the HM questionnaire. 
3. Subject completes a self-reported GAIS (S-GAIS). 
4. PI completes the GAIS form (PI-GAIS). 
5. PI rates the subject on the OCSS and POLSS at rest. 
6. Subject undergoes standardized digital photography and video of full face in accordance 
with the site’s SOP (described in Appendix I); 
 
9.4 
Visit 4: 14-Day Post-OCR 
Visit 4 will take place 14 ± 3 days after Visit 3, OCR Evaluation only for subjects who required 
a touch-up injection in Visit 3 in order to achieve OCR. 
 
The following procedures will be performed: 
 
1. Subject completes the SHS questionnaire. 
2. Subject completes the HM questionnaire. 
3. Subject completes a self-reported GAIS (S-GAIS). 
4. PI completes the GAIS form (PI-GAIS). 
5. PI rates the subject on the OCSS and POLSS at rest. 
6. Subject undergoes standardized digital photography and video of full face in accordance 
with the site’s SOP (described in Appendix I); 
7. A report of occurrence of any AEs and changes in concomitant medications is obtained 
from the subject. 
 
9.5 
Post-Visit Evaluations 
Photographs of subjects taken at Visit 1, Screening Assessments and at Visit 4, 14-Day 
Post- OCR will be used to assess alterations in the projected first impression (see Section 
10.1.1 for further details). 
 
10 RESPONSE CRITERIA 
 
10.1 Primary Variable Assessments 
The primary assessment of this study is to determine if subjects who receive lip rejuvenation 
treatment with Restylane® Silk would project a more positive first impression as well as 
experience a more positive mood perception as compared to their baseline. The primary efficacy 
will be established by comparing the projected first impression of subjects at 14-Day Post-OCR 
with that of the baseline. The change is mood perception will be determined by comparing the 
SHS and HM results from 14-Day Post-OCR with those from the baseline. 
10.1.1 Assessment of First Impressions 
Upon completion of the study, a minimum of 200 blinded evaluators will assess one of four 
binders, for a minimum of 50 blinded evaluators per binder, each comprised of 10 
photographs selected randomly from Visit 1 (baseline) or Visit 4 (14-Day Post-OCR) for 
each subject. The 

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FIQ will be completed by each evaluator for each photo (see Appendix F). Each photograph 
will be graded based on a 10-point numerical rating scale for each of the 8 categories listed 
below: 
 
   Social skills: Social desirability, temperament, positive mood, getting along with others, 
friendliness 
Academic performance: Intelligence, educational skills 
Dating success: Frequently invited, lack of dating anxiety, thought of positively after 
dating encounter 
   Occupational success: Job performance, competence, motivation for success, suitability as 
potential employee 
Attractiveness: Pleasing appearance 
Financial success: Has achieved or is a member of an elevated socioeconomic status 
Relationship success: Willingness to compromise put the relationship health before their 
own desires or gain, Ability to maintain long term friendships 
   Athletic skills: Ability to excel at athletic events, including individual and team sports 
10.1.2 Subjective Happiness Scale (SHS) Evaluation 
Changes in subjects’ mood will be determined partially through the SHS questionnaire (Appendix B) 
completed by subjects at Visit 1, Screening Assessments (baseline) and at Visit 4, 14-Day 
Post-OCR. 
10.1.3 The Happiness Measures (HM) Evaluation 
Changes in subjects’ mood will be determined partially through the HM questionnaire (Appendix 
C) completed by subjects at Visit 1, Screening Assessments (baseline) and at Visit 4, 14-
Day Post-OCR. 
 
10.2 Secondary Variable Assessments 
The secondary variables evaluated in this study include changes in the overall aesthetic 
improvements, determined as described below. 
10.2.1 Subject Global Aesthetic Improvement Scale (S-GAIS) Evaluation 
Changes in global aesthetics will be determined through subjects’ self-assessments utilizing the GAIS 
(Appendix D) at Visit 4, 14-Day Post-OCR. 
10.2.2 PI Global Aesthetic Improvement Scale (PI-GAIS) Evaluation 
Changes in global aesthetics will be determined partially by the PI’s assessment of subjects at Visit 4, 14-Day 
Post-OCR utilizing the GAIS (Appendix E). 
10.2.3 Oral Commissure Severity Scale (OCSS) Evaluation 
Aesthetic improvement will be determined by the PI’s assessment of subjects at Visit 1, Treatment 
(baseline) and at Visit 4, 14-Day Post-OCR partially through utilizing the OCSS 
(Appendix G) 

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10.2.4 Perioral Lines Severity Scale (POLSS) at Rest Evaluation 
Aesthetic improvement will be determined by the PI’s assessment of subjects at Visit 1, Treatment 
(baseline) and at Visit 4, 14-Day Post-OCR partially through utilizing the POLSS 
(Appendix H). 
 
11 DATA MANAGEMENTS 
 
11.1 Case Report Forms 
For each subject enrolled who has given informed consent, completed the screening process, and 
began the study process, a Case Report From (CRF) will be created and signed by the PI or 
designee to certify completeness and correctness. 
 
If a subject is withdrawn from the study due to a treatment-related AE, due diligence must 
be used to document the outcome. Source documentation verification will be performed by 
the study monitors. All CRFs will remain at the study site. 
 
11.2 Data Handling 
Data management based on GCP refers to the activities defined to achieve safe routines for 
efficiently entering clinical data information into a database while avoiding errors. The data 
management routines include procedures for handling CRFs, database set-up and management, 
data entry and verification, data validation, and documentation of the performed activities 
including information of discrepancies in the process. 
 
The database, the data entry screens, and program will be designed in accordance with the study 
protocol and the CRF. Single data entry and proofreading will be used for data entry and 
verification. Data validation will be performed after data entry and verification by manual review. 
When the clinical study coordinator has made all efforts to ensure that the data recorded in the 
CRFs and entered in the database is as correct and complete as possible, "clean file" is declared, and 
the database is closed. The clinical study coordinator should document the database closure in a 
signed written document. Final statistical analysis should be generated using data from the closed 
database. Any additional subsequent changes or corrections to the closed database should be 
documented in an audit trail. 
 
11.3 Publication 
Following completion of the study, the data may be considered for reporting at a scientific 
meeting or for publication in a scientific or medical journal. 

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12 STATISTICAL METHODS 
 
12.1 Sample Size 
20 subjects will be enrolled as described in Section 7. Using the primary end point of FIQ 
scores, and assuming a standard deviation of 14 and a difference of 2.56 in the total FIQ score 
between the baseline and 14-Day Post-OCR, a sample size of 20 will provide a power of 
approximately 8% (with =0.05). 
 
12.2 Study Population 
The study population will include all subjects who are enrolled and have received treatment. The 
entire study population will be included in the statistical analyses. 
 
12.3 Study Endpoints 
12.3.1 Primary Endpoints 
1. FIQ completed by 200 blinded evaluators using the photos of subjects from the 
baseline and the 14-Day Post-OCR visits 
2. Subjects’ execution of the SHS at 14-Day Post-OCR 
3. Subjects’ completion of the HM questionnaire at 14-Day Post-OCR 
12.3.2 Secondary Endpoints 
1. S-GAIS evaluation at 14-Day Post-OCR 
2. PI-GAIS evaluation at 14-Day Post-OCR 
3. OCSS evaluation at 14-Day Post-OCR 
4. POLSS evaluation at 14-Day Post-OCR 
 
12.4 Methods of Analysis 
Descriptive statistics will be used to analyze the data. The number of subjects (n), minimum 
(min), maximum (max), mean, median, and standard deviation (SD) will be reported for 
the continuous data. Frequencies and percentages will be reported for the categorical data. 
Unless otherwise stated, statistical testing will be two-sided and executed using a significance 
level of 
0.05. All statistical analyses, summary tables, and data listings will be performed using the 
SPSS (IBM) or the Excel (Microsoft Co.) software. 
 
13 ADVERSE EVENTS 
 
13.1 Definition 
An adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical 
investigation subject administered a pharmaceutical or medical device product that does not 
necessarily have a causal relationship with this treatment. Adverse events include the following: 
all suspected adverse device or procedure reactions, occurrence of apparently unrelated illnesses 

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(i.e., symptoms or diseases that were not present at study entry), worsening of a pre-existing 
illness (i.e., concurrent symptoms or diseases), injuries or accidents, and abnormalities in 
physiological or laboratory testing or physical examination findings that require clinical 
intervention or further investigation (beyond ordering a repeat confirmatory test). Throughout the 
study, subjects will be monitored for signs and symptoms of adverse events. 
 
All adverse events reported during the study period will be recorded in detail in the subject’s medical file and 
CRF. 
 
13.2 Recording of Adverse Events 
Subjects will be instructed by the PI to immediately report the occurrence of any adverse 
event. Each subject should be questioned at all visits whether any side effects or adverse 
events have occurred. All spontaneously volunteered, inquired, and observed adverse 
experiences will be recorded in detail. 
 
13.3 Serious Adverse Events and Unanticipated Adverse Device Effects 
13.3.1 Definition 
Serious Adverse Events (SAEs) are defined as undesirable events experienced by a subject 
that suggest a significant hazard, contraindication, side effect, or precaution, whether or 
not considered to be device-related by the Investigator. An AE is defined as being serious 
if: 
 
1. It is fatal or life threatening (life threatening means that in the opinion of the 
Investigator, the subject was at immediate risk of death from the adverse 
reaction) 
2. It is permanently or temporarily disabling 
3. It requires inpatient or prolonged hospitalization 
4. Is a congenital anomaly/birth defect 
 
An unanticipated adverse device effect is defined as any serious adverse effect on health or 
safety, any life threatening problem, or death that was not previously identified in nature, 
severity, or degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem associated with a 
device that relate to the rights, safety, or welfare of subjects. 
13.3.2 Serious Adverse Events Recording and Reporting 
Any serious and/or unexpected adverse event that occurred while on study or one month after 
completion of study must be reported to DeNova Research via telephone. The Serious Adverse 
Event Report Form must be completed and faxed to DeNova Research and IRB within 24 
hours of notification. 
 
In addition, the local IRB or EC must be notified of all adverse events that are serious 
and/or unexpected. 

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All adverse events, including serious and unexpected events, must be recorded by the 
Investigator on the standard Adverse Event Report form. This form will be included in the 
CRF. All Adverse Event Reports describing adverse events other than serious or unexpected 
adverse events will be inserted into the CRF. In addition, any serious and treatment-related 
unexpected adverse events must be reported to the local IRB within 5 business days of the 
event. 
 
Subjects who have had a serious adverse event must be followed clinically until all parameters, 
including laboratory values, have either returned to normal or are otherwise explained. If death 
was the outcome of the event on the initial Adverse Event Report, a Follow-up/Final Report, 
including an autopsy report, when performed, must be completed. 
 
14 QUALITY ASSURANCE 
 
14.1 Institutional Review Board Approval 
An IRB shall review and have authority to approve, require modifications, or disapprove the 
investigation. Accordingly, this protocol, the informed consent document, and any relevant 
supporting information must be submitted to the IRB for review and receive approval prior 
to study initiation. Except in an emergency, any amendments to the protocol require approval 
by both Sponsor and the IRB prior to their implementation. 
 
Additionally, the PI is responsible for providing the IRB with progress reports of the 
investigation at regular intervals (at least once per year) as well as with any other 
accurate, complete, and current information that the IRB may request concerning the 
investigation. 
 
14.2 Informed Consent 
Informed consent shall be documented by the use of a written consent form approved by the 
IRB and signed by the subject or the subject’s legally authorized representative. A copy of the final, IRB-
approved document must be provided for record-keeping purposes. Originals of the IRB- 
approved consent form and sign individual consent documents must be retained in the site’s 
study files. Each subject must be provided with a copy of his/her signed consent form. 
 
14.3 Study Monitoring 
The PI will allow designees from the study sponsor to periodically audit all CRFs and 
corresponding source documents for each subjects, as well as, any data related to the study file. 
The monitoring visits provide for an opportunity to evaluate the progress of the study, to verify 
the accuracy and completeness of CRFs, to resolve any inconsistencies in the study records, and 
to assure that all protocol requirements, applicable regulations, and Investigator’s obligations are being met. 
The PI must maintain source documents such as lab reports, photographs, history, and physical 
examination reports, etc., for possible review. 

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14.4 Modification of Protocol 
If modification of the protocol is necessary, the modification must be confirmed with the 
IRB. No changes to the protocol that would significantly affect the safety, scope, or quality of 
the study may be implemented prior to written approval of the IRB. Changes to the 
protocol, however, may be made when necessary for the health of the subject. All 
modifications must be documented at the site. Moreover, if the study protocol is revised at 
any point during the study, IRB will be notified according to CRF 21 Part 812. 
 
14.5 Departure from the Protocol 
Minor deviations to the study protocol may be permitted if they will not increase the subject’s risk or affect 
the validity of the study. All deviations must be documented at the study site. 
 
When an emergency occurs that requires a departure from the protocol for an individual, a 
departure will be only for that subject. The PI in such an emergency will, if circumstances and 
time permit, contact the IRB prior to departing from the protocol. If this is not possible, such 
contact must be made as soon as possible in order to allow for an evaluation of the significance 
of such departure to the affected subject and to other subjects and to permit a decision as to 
whether or not the subject, for whom the departure from the protocol was affected, is to 
continue in the study. The CRFs will completely describe the departure from the protocol and 
state the reasons for such departure. In addition, IRB will be notified in writing of such 
departure from protocol. 
 
14.6 Confidentiality of Subject Records 
The information obtained during the conduct of this study is confidential, and will be disclosed 
only to the Investigator and regulatory authorities as deemed necessary and/or as required by 
law. The PI must provide full disclosure of all study data and make study files available for 
inspection upon request by the IRB and/or relevant authorities including the study sponsor. 
Upon notice, the local authorities may inspect and copy records that identify subjects through 
number and initial combinations. However, such copies have to be blinded (i.e., all 
personally identifiable data have to be blacked out) in order to prevent identification. The 
sponsor will be notified of any impending inspections relating to the study. 
 
14.7 Record Retention 
The PI shall maintain accurate, complete, and current records relating to the participation in 
this study, including the following: 
 
1. All correspondence including required reports 
2. Records of device shipment and disposition 
3. Signed Investigator Agreements 
4. The protocol and any protocol amendments 
5. Records concerning adverse events whether anticipated or not 
6. Documentation of each subject’s case history and exposure to the device, including any CRFs, signed 
and dated consent forms, and any relevant medical records 

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7. Any other records that the applicable authorities require to be maintained by regulation or 
by specific requirement for a particular device or category of devices 
 
The PI shall maintain all detailed essential documents for the duration of the investigation 
and for a period of at least 2 years since the formal discontinuation of clinical development 
of the investigational product, or 2 years after the last approval of any marketing 
application, or as required by the applicable regulatory requirements, whichever is a 
longer period. 
 
14.8 Additional Principal Investigator Responsibilities 
The PI is responsible for protecting the rights, safety, and welfare of subjects under his/her care. 
The PI is responsible for ensuring that the study is conducted according to the signed agreement 
with the investigational protocol, applicable regulations, and any condition of approval imposed 
by the IRB. 

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15 APPENDICES 
Appendix A Schedule of Events 
 
 
Study Visit 
Visit 1: 
Screening 
Visit 2: 
Treatment 
Visit 3: 
OCR 
Evaluation 
Visit 4: 
14-Day 
Post-OCR 
Post-Visit 
Evaluation 
Scheduled Assessment Day 
≤ -14 
1 
14 (±3) 
28 (±3) 
Informed Consent 
X 
Confirm Enrollment Criteria 
X 
Demographics 
X 
Photo- and Videography 
X 
Xc 
Xd 
Safety Evaluations 
Medical History 
X 
Vital Signs 
X 
Urine Pregnancy Testa 
X 
Xb 
Adverse Events 
X 
X 
X 
Concomitant 
Medications 
X 
X 
X 
X 
Patient-Reported Outcomes 
SHS 
X 
Xc 
Xd 
MH 
X 
Xc 
Xd 
S-GAIS 
Xc 
Xd 
PI-Reported Outcomes 
OCSS 
X 
Xc 
Xd 
POLSS 
X 
Xc 
Xd 
OCR Evaluation 
X 
PI-GAIS 
Xc 
Xd 
Blinded Evaluator-Reported Outcomes 
FIQ 
X 
a For females of child-bearing age 
b If the period between Visit 1, Screening Assessments and Visit 2, Treatment is greater than 14 days 
c Subjects who have achieved OCR 
d Subjects who required a touch-up injection in Visit 3 

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Appendix B Subjective Happiness Scale (SHS) 
 
For each of the following statements and/or questions, please circle the point on the scale that 
you feel is the most appropriate in describing you. 
 
 
1. In general, I consider myself: 
1 
2 
3 
4 
5 
6 
7 
not a very 
a very 
happy 
happy 
person 
person 
2. Compared with most of my peers, I consider 
myself: 
1 
2 
3 
4 
5 
6 
7 
not a very 
a very 
happy 
happy 
person 
person 
3. Some people are generally very happy. They enjoy life regardless of what is going on, 
getting the most out of everything. To what extent does this characterization describe you? 
1 
2 
3 
4 
5 
6 
7 
not a very 
a very 
happy 
happy 
person 
person 
4. Some people are generally not very happy. Although they are not depressed, they never 
seem as happy as they might be. To what extent does this characterization describe you? 
1 
2 
3 
4 
5 
6 
7 
not at all 
a great deal 

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Appendix C The Happiness Measures (HM) 
DATE 
 
  
NAME 
 
  
AGE  
SEX   
   
EMOTIONS QUESTIONNAIRE 
 
PART I : Use the list below to answer the following question: IN GENERAL, HOW 
HAPPY OR UNHAPPY DO YOU USUALLY FEELY? Check the o ne statement below 
that best describes your average happiness. 
 
☐10. Extremely happy (feeling ecstatic, joyous, fantastic! 
☐9.  Very happy (feeling really good, elated!) 
☐8.  Pretty happy (spirits high, feeling good.) 
☐7. Mildly happy (feeling fairly good and somewhat cheerful.) 
☐6. Slightly happy (just a bit above neutral.) 
☐5. Neutral (not particularly happy or unhappy.) 
☐4. Slightly unhappy (just a bit below neutral.) 
☐3. Mildly unhappy (just a little low.) 
☐2. Pretty unhappy (somewhat “blue”, spirits down.) 
☐1. Very unhappy (depressed, spirits very low.) 
☐0. Extremely unhappy (utterly depressed, completely down.) 
 
PART II : Consider your emotions a moment further. On the average, what percent of the time 
do you feel happy? What percent of the time do you feel unhappy? What percent of the time do 
you feel neutral (neither happy nor unhappy)? Write down your best estimates, as well as you 
can, in the spaces below. Make sure the three figures add-up to 100%. 
 
ON THE AVERAGE: 
The 
percent 
of 
time 
I 
feel 
happy 
 
% The percent of time I feel unhappy  
% 
The percent of time I feel neutral  
Check just one of these 

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% 
TOTAL 
100 
% 

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Appendix D Subject Global Aesthetic Improvement Scale (S-
GAIS) 
 
 
 
Please rate the change in your appearance now as compared to before you received the 
Restylane® Silk lip rejuvenation treatment. Please circle the appropriate number that you believe 
corresponds to the change in your appearance. 
 
 
 
 
Rating 
Description 
1 
Very Much Improved 
Optimal cosmetic result in subject 
2 
Much Improved 
Marked improvement in appearance from the initial condition 
but not completely optimal for this subject 
3 
Improved 
Obvious improvement in appearance from initial condition but 
a re-treatment is indicated 
4 
No Change 
The appearance is essentially the same as the original condition 
5 
Worse 
The appearance is worse than the original condition 

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Appendix E PI Global Aesthetic Improvement Scale (PI-GAIS) 
 
 
 
Please rate the change in the patient’s appearance now as compared to before the Restylane® Silk 
lip rejuvenation treatment. Please circle the appropriate number that you believe corresponds to 
the change in the subject’s appearance. 
 
 
 
Rating 
Description 
1 
Very Much Improved 
Optimal cosmetic result in subject 
2 
Much Improved 
Marked improvement in appearance from the initial condition 
but not completely optimal for this subject 
3 
Improved 
Obvious improvement in appearance from initial condition but 
a re-treatment is indicated 
4 
No Change 
The appearance is essentially the same as the original condition 
5 
Worse 
The appearance is worse than the original condition 

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Appendix F First Impressions Questionnaire (FIQ) 
 
 
 
Date 
 
Initials 
 
Age             
Sex:  ☐Male 
☐Female 
 
 
Introduction: 
 
Thank you for agreeing to participate in our study. All photographs are patients of this 
practice and have given their consent to be in the study. 
Please do not share your interpretations with others. 
Please attempt to be as honest and unbiased as possible and do not think too much before 
answering each question. 
We really would like your first impression. 
If you have any questions, please ask BEFORE starting. 
 
 
 
Instructions: 
 
Step 
Description 
1 
Please evaluate the following photographs in the books provided. 
2 
Complete the questionnaire for EACH photograph based on your FIRST impression. 
3 
EACH sheet is double-sided, so flip page to backside to complete next patient. 
4 
Hand the completed questionnaires and books back to study specialist. 

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Photo ID: 
Your Initials:   
 
 
Instructions: 
 
1. Please look at the picture and ensure the version and number match the Photo ID above. 
2. Select the number rating that matches EACH question. 
3. Scale is as follows for EACH questions: 1 is DISAGREE and 10 is the AGREE ranking 
 
Subject: 
Description: 
1 
Social Skills 
Positive mood, gets along with others well, friendly 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
DISAGREE 
AGREE 
2 
Academic 
Performance 
Intelligent, highly educated, received good grades in school 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
DISAGREE 
AGREE 
3 
Dating 
Success 
Dates frequently, lacks dating anxiety 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
DISAGREE 
AGREE 
4 
Occupational 
Success 
Good worker, competent, motivated for success, suitable as 
potential employee 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
DISAGREE 
AGREE 
5 
Attractiveness 
Pleasing appearance 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
DISAGREE 
AGREE 
6 
Financial 
Success 
Has achieved financial success, member of a high social class 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
DISAGREE 
AGREE 
7 
Relationship 
Success 
Willingness to compromise, ability to maintain long term 
friendships 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
DISAGREE 
AGREE 
8 
Athletic 
Success 
Excels at athletic skills, plays individual and/or team sports 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
DISAGREE 
AGREE 

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Appendix G Oral Commissure Severity Scale (OCSS) 
 
 
 
 
 
 

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Appendix H Perioral Line Severity Scale (POLSS) at Rest 
 
 
 
 

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Appendix I Standard Operating Protocol for Photo- and Videography 
 
Photography and Poses 
 
   Use the grid feature on any of these viewers to ensure the Frankfort Plane (imaginary line 
from tragus to infraorbital rim) is parallel to the floor. 
Stand approximately 1.5 m from patient with the camera in a portrait position. 
Ensure the patient has a relaxed expression and that lips are closed and eyes are open for 
each photo. 
   Give instructions like, “Slowly move your chin down” or “Slowly turn your nose to the left” to achieve 
the desired poses listed below 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Video 
 
 
 
Standard Poses (all at 1.5 m) 
 
1. Frontal 
Make sure the patient doesn’t have their chin high or low by checking the Frankfort 
Plane. For this view, the line on the viewfinder should extend from the 
right tragus, across both infraorbital rims and across the left tragus. 
This should be parallel to the floor. 
 
2. 45° Left 
For this view, the tip of the nose should line up with the edge of the cheek. 
 
3. Left Profile 
For this view, ensure the patient is not rotated to the left or right 
(hint: look at the eyebrows to see how much of the glabella you 
see). 
 
4. 45° Right 
For this view, the tip of the nose should line up with the edge of the cheek. 
 
5. Right Profile 
For this view, ensure the patient is not rotated to the left or right 
(hint: look at the eyebrows to see how much of the glabella you 
see). 
 
 
Stand approximately 1.75 m from the patient with the camera in a landscape 
position. Standard facial expressions (holding each expression for 2-3 
seconds): 

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1. M
a
x
i
m
u
m 
s
m
i
l
e 
(
s
h
o
w
i
n
g 
t
e
e
t
h
) 
2. M
a
x
i
m
u
m 
f
r
o
w
n 
(
f
u
r
r
o
w
i
n
g 
b
r
ow) 
3. Pucker lips 
4. Read two rhymes of approximately 30 seconds 

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16 REFERENCES 
1. 
Naumann LP, Vazire S, Rentfrow PJ, Gosling SD. Personality Judgments Based 
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2. 
Borkenau P, Liebler A. Trait inferences: Sources of validity at zero acquaintance. 
Journal of Personality and Social Psychology. 1992;62(4):645–57. 
3. 
Albright L, Kenny DA, Malloy TE. Consensus in personality judgments at zero 
acquaintance. Journal of Personality and Social Psychology. 1988  Sep;55(3):387–
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4. 
Krebs D, Adinolfi AA. Physical attractiveness, social relations, and personality 
style. Journal of Personality and Social Psychology. 1975 Feb;31(2):245–53. 
5. 
Pope AW, Ward J. Factors associated with peer social competence in preadolescents 
with craniofacial anomalies. J Pediatr Psychol. 1997 Aug;22(4):455–69. 
6. 
Dayan SH, Arkins JP, Gal TJ. Blinded evaluation of the effects of hyaluronic acid 
filler injections on first impressions. Dermatol Surg. 2010 Nov;36 Suppl 3:1866–
73. 
7. 
Dayan SH, Lieberman ED, Thakkar NN, Larimer KA, Anstead A. Botulinum toxin a 
can positively impact first impression. Dermatol Surg. 2008 Jun;34 Suppl 1:S40–
7. 
8. 
Dayan S, Clark K, Ho AA. Altering First Impressions After Facial Plastic Surgery. 
Aesth Plast Surg. Springer-Verlag; 2004 Nov 4;28(5):301–6. 
9. 
Dayan SH, Arkins JP, Patel AB, Gal TJ. A Double -Blind, Randomized, Placebo- 
Controlled Health-Outcomes Survey of the Effect of Botulinum Toxin Type A 
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10. 
ASPS. 2013 Plastic Surgery Statistics Report [Internet]. American Society of Plastic 
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surgery-statistics-full-report-2013.pdf 
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Lyubomirsky S, Lepper HS. A measure of subjective happiness: Preliminary 
reliability and construct validation. Social Indicators Research. 1999 
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12. 
Mattei D, Schaefer CE. An investigation of validity of the subjective happiness 
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Michalos AC. Citation Classics from Social Indicators Research. Springer Science 

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& Business Media; 2006. 1 p. 
14. 
Galderma Laboratories, L.P. Restylane® Silk. Fort Worth, TX: Galderma 
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