LIPS: A Prospective, Open-label Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation
Phase: PHASE4
Conditions: Lip Augmentation
Sponsor: Allergan

 
   
 
 
 
         NCT 03796728 
 
Study ID: CMO-MA-FAS-0512 
 
 
Title: LIPS:  A Prospective, Open-label Study to Evaluate the Effectiveness 
of Juvéderm® VOLIFT™ with Lidocaine for Lip Augmentation 
   
                                  Protocol Date: 10-OCT-2019 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3,   10 OCTOBER 2019 
 
Page 2 
PRINCIPAL INVESTIGATOR’S AGREEMENT 
I have read and understand the contents of this clinical protocol for Study No. CMO-MA-
FAS-0512 Version 3 dated   10th October 2019 and will adhere to the study requirements as 
presented, including all statements regarding confidentiality 
I agree to: 
• Implement and conduct this study diligently and in strict compliance with the 
protocol, good clinical practices and all applicable laws and regulations. 
• Maintain all information supplied by Allergan in confidence and, when this 
information is submitted to an Independent Ethics Committee (IEC) or another group, 
it will be submitted with a designation that the material is confidential. 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
Signature 
 
Date 
 
Name of Principal Investigator: 
 
 
 
Name of Clinic 
 
 
 
 
 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3,   10 OCTOBER 2019 
 
Page 3 
 
SPONSOR’S REPRESENTATIVE: 
 
 
 
 
DATE: 
 
 
  10th October 2019 
 
 
 
 
 
 
 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3,   10 OCTOBER 2019 
 
Page 4 
 
PROTOCOL SUMMARY 
Sponsor: 
Allergan Pharmaceuticals 
International Limited, 
Clonshaugh Industrial 
Estate, Coolock,  
Dublin 17, Ireland 
Investigational Products: 
Juvéderm® VOLIFT™ with Lidocaine 
Developmenta
l Phase: 
Phase IV, Post-
marketing 
Title of Study:  LIPS: Prospective, open-label study to evaluate the effectiveness of 
Juvéderm® VOLIFT™ with Lidocaine for lip augmentation  
Protocol Number:  CMO-MA-FAS-0512 
Number of Subjects: 60 subjects 
Indication:  Lip augmentation  
Primary Study Objective: 
To evaluate the effectiveness of Juvéderm® VOLIFT™ with Lidocaine for lip 
augmentation.  
Secondary Study Objectives: 
To quantify the Investigators’ and subject’s assessment of aesthetic improvement of their 
lips. 
Methodology: 
This is a prospective, open-label, multi-centre, interventional, medical device, post-
marketing study.  Each subject will act as his/her own control.  Eligible subjects will 
undergo treatment with Juvéderm® VOLIFT™ with Lidocaine injected into the lips for lip 
augmentation.  
All subjects will sign an informed consent form, and begin at the Screening Visit (V0).  
Filler treatment (Juvéderm® VOLIFT™ with Lidocaine) will be performed at V1 (Initial 
Treatment visit) and data will be collected at this visit for all relevant parameters as per the 
Schedule of Study Procedures, Treatments and Assessments (Table 1.1).  Fourteen days 
after the initial treatment, subjects will return to the clinic and the Investigator will assess 
whether a Touch-up treatment is to be performed at this visit (V2).  Follow-up visits will 
occur at V3, V4, V5, and V6 at 1, 3, 6, 12 months after the last treatment.  

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3,   10 OCTOBER 2019 
 
Page 7 
6. 
Has undergone semi-permanent dermal filler treatment (e.g., hyaluronic acid, calcium 
hydroxylapatite, poly-L-lactic acid) in the lower face (below the orbital rim) within 24 
months before enrollment or is planning to undergo such treatment during the study 
7. 
Has undergone mesotherapy or cosmetic resurfacing (laser, photo-modulation, intense 
pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative or non-
ablative procedures) anywhere in the face or neck, or Botulinum toxin injections in 
the lower face (below the orbital rim) within 6 months before enrollment or is 
planning to undergo any of these procedures during the study 
8. 
Has used any lip plumping products within 10 days before enrollment or is planning 
to use such products during the study (study treatment may be delayed as necessary to 
accommodate this 10-day washout period) 
9. 
Has begun using any over-the-counter or prescription, oral or topical, anti-wrinkle 
products for the lips or around the mouth within 90 days before enrollment or is 
planning to begin using such products during the study (subjects who have been on a 
regimen of such products for at least 90 days are eligible for the study if they intend to 
continue their regimen throughout the study) 
10. Is on an ongoing regimen of anti-coagulation therapy (e.g., warfarin) or non-steroidal 
anti-inflammatory drugs (NSAIDs) (e.g., aspirin, ibuprofen) or other substances 
known to increase coagulation time (e.g., herbal supplements with garlic or gingko) 
within 10 days of undergoing study device treatment (study treatment may be delayed 
as necessary to accommodate this 10-day washout period) 
11. Is on a concurrent regimen of lidocaine or structurally related local anesthetics (e.g., 
bupivacaine) 
12. Has a history of anaphylaxis, atopy, or allergy to lidocaine, hyaluronic acid (HA) 
products, or Streptococcal protein, or is planning to undergo desensitization therapy 
during the study 
13. Has an active inflammation, infection, cancerous or precancerous lesion, or unhealed 
wound in the mouth area 
14. Has porphyria 
15. Has epilepsy 
16. Has impaired cardiac conduction, severely impaired hepatic function, or severe renal 
dysfunction 
17. Has any uncontrolled disease 
18. Females who are pregnant, nursing, or planning a pregnancy 
19. Current enrollment in an investigational drug or device study, participation in such a 
study within 6 weeks before enrollment, or be planning to participate in another 
investigation during the course of this study 
20. Is an employee (or immediate relative of an employee) of the Investigator, Allergan, 
or a representative of Allergan 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
 
 
 
 
 
 
VERSION 3
 
Page 10 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
 
 
 
 
 
 
 
VERSION 3
 
Page 11 
  
  
  
  

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
Confidential 
Page 12 
TABLE OF CONTENTS 
PROTOCOL SUMMARY .........................................................................................................4 
TABLE OF CONTENTS .........................................................................................................12 
LIST OF ABBREVIATIONS ..................................................................................................17 
1 INTRODUCTION .............................................................................................................18 
1.1 
Background ............................................................................................................18 
1.2 
Juvéderm® Products ...............................................................................................18 
2 STUDY OBJECTIVES AND CLINICAL HYPOTHESIS ...............................................20 
2.1 
Study Objectives ....................................................................................................20 
2.1.1 
Primary Study Objective ............................................................................20 
2.1.2 
Secondary Study Objectives ......................................................................20 
2.2 
Clinical Hypothesis ................................................................................................20 
3 STUDY DESIGN...............................................................................................................20 
4 STUDY POPULATION AND ENTRY CRITERIA .........................................................21 
4.1 
Number of Subjects................................................................................................21 
4.2 
Inclusion Criteria ...................................................................................................21 
4.3 
Exclusion Criteria ..................................................................................................22 
4.4 
Permissible and Prohibited Medications/Treatments.............................................23 
4.4.1 
Permissible Medications and/or Treatments ..............................................23 
4.4.1.1 
Anesthesia ..........................................................................................23 
4.4.1.2 
Rescue Medications ...........................................................................23 
4.4.1.3 
Acceptable Contraceptive Methods ...................................................24 
4.4.2 
Prohibited Medications/Treatments ...........................................................24 
4.4.2.1 
Anticoagulant Medications ................................................................24 
4.4.2.2 
Facial Procedures/Treatments ............................................................24 
4.4.2.3 
Special Diet or Activities ...................................................................24 
5 TREATMENT ...................................................................................................................25 
5.1 
Investigational Product ..........................................................................................25 
5.1.1 
Blinding and Randomization .....................................................................25 
5.2 
Storage, Handling and Destruction ........................................................................25 
 
 
5.2.2 
Handling .....................................................................................................25 
5.2.3 
Destruction .................................................................................................25 
5.3 
Treatment Administration ......................................................................................25 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
Confidential 
Page 13 
6 STUDY VISIT SCHEDULE AND PROCEDURES ........................................................26 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7 METHODS OF ASSESSMENT AND ENDPOINTS .......................................................34 
7.1 
Study Procedures ...................................................................................................34 
7.1.1 
Demographic Data .....................................................................................34 
7.1.2 
Medical History .........................................................................................34 
7.1.3 
Concomitant Medications/Procedures .......................................................34 
7.1.4 
Fitzpatrick Skin Phototype .........................................................................35 
7.1.5 
Urine Pregnancy Test .................................................................................35 
7.1.6 
Photographs................................................................................................36 
7.1.7 
Injection Site Reaction (ISR) 30-Day Diary ..............................................37 
7.1.7.1 
Day 1 Visit (Treatment) .....................................................................37 
7.1.7.2 
Day 14 Visit (Touch-up, if required) .................................................37 
7.1.7.3 
Day 30 Visit .......................................................................................37 
7.2 
Efficacy Measures ..................................................................................................37 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
Confidential 
Page 14 
7.2.1 
Lip Fullness Scale (LFS2) .........................................................................37 
7.2.2 
Oral Commissures Severity Scale (OCSS) ................................................38 
7.2.3 
FACE-Q Satisfaction with Lips .................................................................38 
7.2.4 
Global Aesthetic Improvement Scale (GAIS) Questionnaires ..................38 
7.2.4.1 
GAIS Investigator ..............................................................................38 
7.2.4.2 
GAIS Subject .....................................................................................38 
8 DISCONTINUATION CRITERIA ...................................................................................39 
8.1 
Discontinuation of the Study .................................................................................39 
8.2 
Discontinuation of Subjects ...................................................................................39 
8.2.1 
Withdrawal Criteria ...................................................................................39 
9 ADVERSE EVENTS .........................................................................................................40 
9.1 
Definitions..............................................................................................................40 
9.1.1 
Adverse Events (AE) .................................................................................40 
9.1.2 
Serious Adverse Events (SAE) ..................................................................40 
9.1.3 
Adverse Device Effect (ADE) ...................................................................41 
9.1.4 
Serious Adverse Device Effect (SADE) ....................................................41 
9.1.5 
Unanticipated Serious Adverse Device Effect (USADE) ..........................41 
9.1.6 
Device Deficiency ......................................................................................41 
9.1.7 
Injection Site Reaction (ISR) .....................................................................42 
9.1.8 
Incident ......................................................................................................42 
9.2 
Procedure for Reporting Adverse Events ..............................................................42 
9.2.1 
Timelines for Reporting .............................................................................42 
9.2.2 
Severity ......................................................................................................43 
9.2.3 
Causality ....................................................................................................43 
9.2.4 
Pregnancy ...................................................................................................45 
9.3 
Procedures for Reporting an SAE/SADE ..............................................................45 
10 STATISTICAL METHODS ..............................................................................................47 
10.1 
General Statistical Considerations .........................................................................47 
10.1.1 
Analysis Populations ..................................................................................47 
10.1.2 
Subgroups ..................................................................................................47 
10.2 
Demographics and Baseline Characteristics ..........................................................47 
10.3 
Exposure and Concomitant Therapies ...................................................................47 
10.4 
Study Endpoints .....................................................................................................48 
10.4.1 
Primary Endpoint .......................................................................................48 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 15 
10.4.2 
Secondary Endpoints .................................................................................48 
10.4.2.1 
Oral Commissures Severity Scale (OCSS) ........................................48 
10.4.2.2 
FACE-Q – Satisfaction with Lips Questionnaire...............................48 
10.4.2.3 
Global Aesthetic Improvement Scales (GAIS) ..................................48 
10.4.2.4 
Natural Look and Feel/Product Smoothness/Dynamic lip lines ........48 
10.5 
Efficacy Analyses ..................................................................................................48 
10.5.1 
Primary Efficacy Analysis .........................................................................49 
10.5.2 
Analysis of All Other Efficacy endpoints ..................................................49 
10.5.3 
Missing Data ..............................................................................................49 
10.5.4 
Adverse Events ..........................................................................................49 
10.6 
Interim Analyses and Data Monitoring..................................................................49 
10.7 
Determination of Sample Size ...............................................................................49 
10.8 
Changes in the Conduct of the Study or Planned Analysis ...................................49 
11 REGULATORY, ETHICAL, AND LEGAL OBLIGATIONS .........................................49 
11.1 
Declaration of Helsinki ..........................................................................................49 
11.2 
Good Clinical Practice ...........................................................................................50 
11.3 
Independent Ethics Committees ............................................................................50 
11.4 
Regulatory Authority Approval .............................................................................50 
11.5 
Protocol Compliance ..............................................................................................50 
11.6 
Informed Consent...................................................................................................50 
11.7 
Subject Confidentiality and Disclosure .................................................................51 
11.8 
Sponsor Monitoring Of Study Documentation ......................................................51 
11.9 
Study Documents ...................................................................................................51 
11.10 Collection of Study Data ........................................................................................51 
11.11 Archiving of Study Documents .............................................................................51 
11.12 Disclosure of Information ......................................................................................52 
12 REFERENCES ..................................................................................................................53 
13 APPENDICES ...................................................................................................................55 
 
 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 16 
 
LIST OF IN-TEXT TABLES 
Table 1.1 
Schedule of Visits and Procedures..................................................................9 
Table 6.1 
Washout Periods of Medications/Treatment.................................................27 
Table 7.1 
Fitzpatrick Skin Phototype............................................................................35 
Table 9.1 
Adverse Events Reporting Timelines ...........................................................42 
 
LIST OF IN-TEXT FIGURES 
Figure 3.1 
Overall Study Design ....................................................................................21 
Figure 7.1 
Pregnancy Test Results .................................................................................36 
LIST OF APPENDICES 
Appendix 1 
Juvederm® VOLIFT™ with lidocaine DFU .................................................56 
Appendix 2 
Injection Site Reaction (ISR) 30-day Diary ..................................................60 
Appendix 3 
Lip Fullness Scale 2 (LFS2) .........................................................................64 
Appendix 4 
Oral Commissure Severity Scale (OCSS) ....................................................65 
Appendix 5 
FACE-Q™: SATISFACTION WITH Lips ...................................................66 
Appendix 6 
Global Aesthetic Improvement Scale (GAIS) ..............................................67 
Appendix 7 
Subject Assessment of Natural Look and Feel .............................................68 
Appendix 8 
Investigator Assessment of Smoothness .......................................................69 
Appendix 9 
Perioral Lines at Rest Severity Scale (POLSS) ............................................70 
Appendix 10 
Investigator Assessment of dynamic lip lines upon animation.....................71 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 17 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition 
AE 
adverse event 
ADE 
adverse device effect 
CFR 
Code of Federal Regulations 
DFU 
Directions For Use 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
GAIS 
global aesthetic improvement scale 
GCP 
Good Clinical Practice 
HA 
hyaluronic acid 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ISR 
injection site reaction 
LFS2 
lip fullness scale 
NSAIDs 
non-steroidal anti-inflammatory drugs 
OCSS 
oral commissures severity scale 
POLSS 
perioral lines severity scale 
SAE 
serious adverse event 
SADE 
serious adverse device effect 
UADE 
unanticipated adverse device effect 
US 
United States 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 18 
1 
INTRODUCTION 
1.1 
BACKGROUND 
As a key aesthetic feature of the face, fullness and voluptuousness of the lips are associated 
with attractiveness, sensuality, and youth.  Similar to the skin, however, the lips are prone to 
intrinsic and extrinsic factors that can dramatically change their appearance over time. 
Repetitive and underlying action of the orbicularis oris muscle leads to the formation of 
visible, fine, vertical rhytides surrounding the lips.  The tolls of gravity coupled with the loss 
of lip volume and support cause the upper lip to lengthen and the lip to fall vertically.  As 
collagen production diminishes, the Cupid’s bow and vermilion border lose their distinction.1  
The morphological changes of the lips over time become an obvious sign of aging.  
Unfortunately, because the connotation with youth is the ability to be an active and productive 
member of society, the pressure on individuals to conceal the signs of aging is tremendous.  
The inability to do so is correlated with increased anxiety and depression.2 
Treatment with temporary dermal fillers can provide volume to the lips and perioral area, 
three-dimensionally restoring the natural contour of the region to which it is applied and 
thereby reducing some of the signs of aging lips.  Several technologies have been developed 
for cosmetic augmentation of the lips, including injection of paraffin, oils, silicone, 
polymethylmethacrylate beads, autologous fat, and injectable collagen.  However, allergic 
reactions, inadequate duration effects, and logistics of the treatment (e.g., separate surgeries) 
have made them impractical.3,4  The development of cross-linked hyaluronic acid (HA)-based 
dermal fillers has since provided a safe, effective, and long-lasting option to volume 
enhancement of the lips.  Currently, lip augmentation is recognized as one of the most 
common uses for dermal fillers, especially HA products.5,6,7,8,9,10,11 
Restoration of aging lips is an intricate endeavor in which the physician must take into 
account the multiple changes that have contributed to their overall aged appearance.  The 
areas of injection for lip augmentation include the cutaneous (white) and red lips, i.e., 
vermilion (body of the red lip), vermilion borders (often in the potential space between the 
skin and the orbicularis oris muscle), Cupid’s bow and philtral columns, perioral rhytides 
(vertical “lipstick” lines), and oral commissures (marionette folds).  Injection into the 
vermilion and vermilion borders may indirectly cause improvement in perioral line severity.  
Treatment of the perioral lines and oral commissures may not be indicated in all patients, and 
treatment to accentuate the Cupid’s bow and/or philtral columns may not be desired by many.  
Ideally, usage of a product with the malleability and range to treat different areas of the lips 
and perioral complex would provide the most realistic and satisfactory aesthetic result. 
1.2 
JUVÉDERM® PRODUCTS 
As described below, the investigations assessing the safety and effectiveness of HA-based 
dermal fillers for volume restoration of the lips have demonstrated treatment success and high 
patient satisfaction.  Longevity of treatment with HA fillers has been reported to be longer 
than treatment with collagen12,13 although the longevity of effect is relatively short-lived 
compared to treatment of other facial areas. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 19 
• In a multi-center European post-marketing study of the safety and effectiveness of 
Juvéderm® VOLBELLA without lidocaine for lip enhancement, 60 subjects desiring lip 
enhancement and who met eligibility criteria were treated.  Interim results 3 months 
post-treatment show that 93.2% of subjects displayed ≥1-point improvement on the 
4-point Lip Fullness Scale and 100% of Investigators and 98.3% of subjects affirmed that 
the pre-established lip fullness goal had been achieved (Study S15-002). 
• In a multi-center clinical feasibility study for lip enhancement using Juvéderm® Ultra 
conducted in the United States (US) (Study JD-003), lip fullness and effectiveness of 
treatment was evaluated in 50 subjects who had established lip fullness goals.  A separate, 
blinded Independent Evaluator and the subject assessed lip fullness, perioral lines, and oral 
commissures using validated scales.  Standardized 3D images were taken to measure lip 
volume changes.  Results showed that 71% of subjects (p < 0.0001) achieved their lip 
fullness goals and improved ≥ 1-point on the 4-point Lip Fullness Scale at the 12-week 
primary endpoint.  Perioral line severity improved for up to 63% of subjects.  Subject 
overall satisfaction at the 12-week endpoint was 82%, and 78% of subjects were willing or 
very willing to undergo study treatment again.14 
• A post-marketing surveillance study assessed treatment comfort and aesthetic effect in 
57 patients treated with Juvéderm® Ultra Smile.  The most common site for injection was 
the vermilion border, and 95% of injectors found the gel easy to inject.  Furthermore, 99% 
of injectors rated improved aesthetic compared to baseline.  Patient satisfaction with the 
product was 96%.15 
 
As with any dermal treatment injection, pain during administration is a possible side effect.  
Importantly, pain experienced during injection may compromise the physician’s ability to 
perform the procedure with precision.12  Physicians typically use pain-relieving agents 
concomitant with injection, such as a nerve block, topical anesthesia, or a local anesthetic.  
The inclusion of lidocaine in the HA formulation itself is intended to reduce the patient’s pain 
during the procedure and reduce or eliminate the need for additional pain-relieving agents.  As 
described below, pain scores have consistently been reduced with HA-based dermal fillers 
containing a standard amount of lidocaine (0.3%) without compromising the aesthetic result.  
Furthermore, lidocaine in the formulation did not affect the rheology, duration of effect, or 
frequency of adverse events.16,17,18,19 
Juvéderm® VOLIFT™ with Lidocaine, included in the Juvéderm® range of products, is a 
malleable product capable of fitting the physical constraints that would be experienced with 
injection and volume expansion of the lips.  The addition of lidocaine (0.3% w/w) is to 
increase patient comfort during treatment.  Thus, the characteristics of Juvéderm® VOLIFT™ 
with Lidocaine should render it effective for lip volume restoration and enhancement, with 
increased patient comfort during treatment and a long-lasting duration. 
The Juvéderm® family of non-animal HA gel implants was first CE marked and marketed in 
Europe in 2000, introduced into Canada in 2002, and US Food and Drug Administration 
(FDA)-approved in 2006.  The Juvéderm® family is now approved in numerous countries 
throughout the world, including Korea (2004), Australia (2006), Mexico (2006), Brazil 
(2007), Columbia (2007), Hong Kong (2009), India (2009), and Taiwan (2009).  Juvéderm® 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 20 
products have not been withdrawn from any country for any reason related to safety and 
effectiveness of the device. 
Juvéderm® VOLIFT™ with Lidocaine gained CE mark in October 2011.  The product label is 
as follows:  medical devices for the treatment of cutaneous depressions and the restoration of 
volumes. 
Refer to the Juvéderm® VOLIFT™ with Lidocaine Directions for Use (Appendix 1) for 
further details of the mitigation of risks of Juvéderm® VOLIFT™ with Lidocaine. 
2 
STUDY OBJECTIVES AND CLINICAL HYPOTHESIS 
2.1 
STUDY OBJECTIVES 
2.1.1 
Primary Study Objective 
To evaluate the effectiveness of Juvéderm® VOLIFT™ with Lidocaine for lip augmentation. 
2.1.2 
Secondary Study Objectives 
To quantify the Investigators’ and subject’s assessment of aesthetic improvement of their 
lips.  
2.2 
CLINICAL HYPOTHESIS 
The clinical hypothesis of this study is that a significant proportion of subjects treated with 
Juvéderm® VOLIFT™ with Lidocaine will achieve at least a 1-point improvement in the 5-
point Lip Fullness Scale (LFS2) at 30 days post last treatment.  Additionally, subjects will 
have a significantly higher satisfaction with lip appearance at post-treatment study visits 
when compared with baseline pre-treatment satisfaction scores, as measured by the mean 
change from baseline on the Satisfaction with Lips FACE-Q questionnaire.  For subjects who 
additionally receive treatment for oral commissures a significant proportion of subjects will 
achieve an improvement in Oral Commissures Severity Scale (OCSS) score(s) at post-
treatment study visits when compared with baseline pre-treatment scores.  Investigators’ and 
subjects’ global satisfaction with the aesthetic outcome will also be assessed.  
3 
STUDY DESIGN 
This is a prospective, open-label, multi-centre, interventional, medical device, post-marketing 
study evaluating the effectiveness of Juvéderm® VOLIFT™ with Lidocaine for lip 
augmentation.  Subjects will attend up to 7 visits: Screening, Initial Treatment, Day 14 
(Touch-up, if required), Day 30, Month 3, Month 6, and Month 12. (Study Exit) (see Figure 
3.1).  60 subjects will be enrolled. 
Eligible subjects will undergo treatment with Juvéderm® VOLIFT™ with Lidocaine 
administered via injection for enhancement as per the current DFU.  Fourteen days after the 
initial treatment, subjects will return to the clinic and the Investigator will assess the 
effectiveness of treatment.  If the Investigator judges that optimum correction has not been 
achieved, an optional Touch-up treatment may be performed during the Day 14 visit.  

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 24 
“off-label” and has not been provided as a part of the study regimen and should not be 
performed during this study.  However, if in the Investigator’s judgment it is deemed to be 
necessary to inject hyaluronidase for the safety of the subject, then the Investigator may 
inject at his/her discretion, capturing this information as a concomitant medication. 
4.4.1.3 
Acceptable Contraceptive Methods 
Women of childbearing potential are required to practice a reliable method of contraception 
throughout the study.  The following methods of contraception, if properly used, are 
generally considered reliable:  oral contraceptives, patch contraceptives, injection 
contraceptives, male condom with intra-vaginal spermicide, diaphragm or cervical cap with 
spermicide, vaginal contraceptive ring, intrauterine device, surgical sterilization (bilateral 
tubal ligation), vasectomized partner, or sexual abstinence.  
The Investigator and each subject will determine the appropriate method of contraception for 
the subject during the participation in the study. 
4.4.2 
Prohibited Medications/Treatments 
The decision to administer a prohibited medication/treatment will be made with the safety of 
the study participant as the primary consideration. When possible, the Sponsor or Sponsor’s 
representative should be notified before a prohibited medication/treatment is administered.  
Prior to attending study visits, subjects must not apply facial cosmetics. 
For information regarding medications requiring washout prior to treatment, see Section 
6.1.3: Washout of Prohibited Medications/Treatments. 
4.4.2.1 
Anticoagulant Medications 
Subjects must not initiate a regimen of anti-coagulation therapy (e.g., warfarin), NSAIDs or 
other substances known to increase coagulation time (e.g., herbal supplements with garlic or 
ginkgo biloba) for 3 days following the procedure. 
4.4.2.2 
Facial Procedures/Treatments 
Subjects must not undergo any type of facial plastic or reconstructive surgery, dental or 
cosmetic procedure [e.g., dental implant, new dentures, face-lift, resurfacing (laser, 
photomodulation, intense pulsed light, radio frequency, dermabrasion, chemical peel, or other 
ablative or non-ablative procedures), tissue augmentation with dermal fillers or fat injections, 
BOTOX® Cosmetic injections, or mesotherapy] anywhere in the lower face (below the orbital 
rim), neck, and oral cavity at any time during the study. 
4.4.2.3 
Special Diet or Activities 
Within the first 24 hours after filler treatment, on V1, if a Touch-up treatment is performed 
on V2, or retreatment at V6, subjects should avoid strenuous exercise, extensive sun or heat 
exposure and alcoholic beverages.  Exposure to any of the above may cause temporary 
redness, swelling, and/or itching at the injection sites. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 27 
For additional information/examples of specific treatment/procedures, refer to Section 4.3 
(Exclusion Criteria). 
Study treatment may be delayed as necessary to accommodate the washout period.  If 
treatment is delayed beyond the 14-day screening period (see Table 1.1: Schedule of Study 
Procedures, Treatments, and Assessments), screening procedures are to be repeated as 
necessary to confirm participation eligibility.  The inclusion/exclusion criteria must be 
reassessed and the patient eligibility confirmed prior to study treatment. 
Table 6.1 
Washout Periods of Medications/Treatment 
6.1.4 
Subject Enrollment 
A subject is considered “entered” into the trial after the subject has signed the Informed 
Consent Form (ICF) and a subject number has been assigned. 
A subject is considered “enrolled” after confirmation of participation eligibility and treatment 
has occurred. 
6.2 
DESCRIPTION OF STUDY VISITS 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 28 
6.2.2 
Treatment 
The Treatment visit is considered as Day 1.  Subjects confirmed to be eligible for 
participation during the screening period will receive study treatment as described in 
Section 5.3: Treatment Administration 
6.2.2.1 
Prior to Study Treatment 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 30 
• Investigator and subject determine if Touch-up Treatment is required. 
6.2.3.2 
For Subjects Receiving Touch-Up Treatment 
6.2.4 
Day 30 Visit 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 31 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 32 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 33 
6.2.8 
Unscheduled Visits 
Each time the subject returns to the study site, the Investigator (or designee) will solicit and 
record information about ISRs, AEs, and concomitant medications/procedures.  An interim or 
unscheduled visit may replace a scheduled visit if it occurs within the acceptable visit 
window for a scheduled visit or if the scheduled visit was missed.  All applicable procedures 
should be performed. 
6.2.9 
Early Discontinuation 
Subjects may withdraw consent for participation or be withdrawn from the study at any time 
without jeopardy to future medical care.  See Section 8: Discontinuation Criteria regarding 
reasons for discontinuations. 
If a subject exits the study prior to month 6, the subject will be asked to attend an end of 
study visit and have all assessments performed and clinical data collected as required by the 
month 6 visit.  If a subject does not consent to the extension of the study at completion of 
their 6-month visit, this will be recorded in the database.   
Participation eligible subjects who withdraw before any treatment is given may be replaced 
by another suitable subject.  The subject number will not be reassigned to a different subject. 
6.3 
POST-TREATMENT INSTRUCTIONS FOR SUBJECTS 
Prior to leaving the study site, the subject’s next study visit should be scheduled and a 
reminder card provided to the subject.  If possible, the remainder of the visits should be 
scheduled at the end of the Day 14 visit. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 34 
7 
METHODS OF ASSESSMENT AND ENDPOINTS 
7.1 
STUDY PROCEDURES 
7.1.1 
Demographic Data 
Subject demographic data will be collected at the Screening Visit. 
These data include age, gender, and Fitzpatrick type. 
7.1.2 
Medical History 
Medical history will be obtained from each subject at the Screening Visit. 
Medical history includes pertinent surgical history and a detailed history of prior aesthetic 
procedures with start and stop dates, if applicable, as well as any discontinuations due to 
intolerability or toxicity.  
7.1.3 
Concomitant Medications/Procedures 
Concomitant medication/procedure status shall be collected at all visits.  Concomitant 
medications include prescription medications, dietary supplements, over-the-counter 
medications, and oral herbal preparations. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 35 
A list of concomitant medications/procedures will be collected at the screening visit.  Data 
collected shall be medication/treatment name, dose, frequency, start date, stop date (if 
applicable).  All medications or treatments received within 30 days before the screening visit 
shall be recorded.  Medications/procedures received more than 30 days before screening and 
in the Investigators judgment is pertinent to this study, should also be recorded. 
Following treatment at Day 1, subjects will be asked at each subsequent study visit whether 
any new medication/procedures have been administered or of any changes in dosage or 
frequency, have occurred since the previous visit.  All concomitant medications and 
procedures will be recorded on eCRFs. 
7.1.4 
Fitzpatrick Skin Phototype 
The subject’s Fitzpatrick skin phototype will be determined at the screening visit using the 
parameters listed in Table 7.1. 
Table 7.1 
Fitzpatrick Skin Phototype 
 
7.1.5 
Urine Pregnancy Test 
The urine pregnancy test will be performed at the screening visit and prior to administration 
of any study treatment (Day 1 and Day 14, if applicable and at retreatment at Month 12).  
The urine pregnancy test will be performed only for women of childbearing potential.  The 
woman’s childbearing status must be clearly reported in the source documentation. 
  Women of childbearing potential 
must have a negative pregnancy test before any study treatments are given.  See Figure 7.1 to 
determine pregnancy status.   
Women who are determined to have negative pregnancy test results may continue in the 
study and receive study treatments as applicable. 
• Women who are determined to have positive pregnancy test results prior to initial 
treatment must be informed of their pregnancy status and discontinued from the study as 
screen failures.   
• Women who are determined to have positive pregnancy test results after receiving the 
initial treatment must be withdrawn from the study and have their pregnancy followed 
and reported per Section 9.2.4: Pregnancy. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 38 
7.2.2 
Oral Commissures Severity Scale (OCSS) 
The Oral Commissure Severity Scale (OCSS) is an Investigator assessment measured on a 
4-point scale (see Appendix 4: Oral Commissure Severity Scale (OCSS)).  The Investigator 
will use the OCSS to perform a live assessment of the subject at the visits specified in 
Table 1.1: Schedule of Study Procedures, Treatments, and Assessments.  Photographic 
images will be collected to capture the subject status at the time of the live assessments. 
7.2.3 
FACE-Q Satisfaction with Lips  
The subject will assess satisfaction using the 10 items on the Satisfaction with Lips 
questionnaire of the FACE-Q (see Appendix 5).  The responses to the items are combined to 
create a scale score that ranges from 0 to 100.  This FACE-Q was designed to assess the 
impact of treatment from the subject’s perspective.  
 
7.2.4 
Global Aesthetic Improvement Scale (GAIS) Questionnaires 
7.2.4.1 
GAIS Investigator 
Investigator’s assessment of global facial aesthetic improvement as measured by the 5-point 
GAIS (see Appendix 6: Global Aesthetic Improvement Scale (GAIS)). 
7.2.4.2 
GAIS Subject 
Subject’s assessment of global facial aesthetic improvement as measured by the 5-point 
GAIS (see Appendix 6: Global Aesthetic Improvement Scale (GAIS)). 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 39 
8 
DISCONTINUATION CRITERIA 
8.1 
DISCONTINUATION OF THE STUDY 
The Investigator or Allergan, may terminate the Investigator’s participation in this study after 
submission of a written notice.  Allergan may terminate the study at any time for any reason. 
8.2 
DISCONTINUATION OF SUBJECTS 
A subject may voluntarily withdraw or the Investigator may withdraw the subject at any time 
without prejudice to the subjects’ future medical care by the investigator or institution.  It is 
the responsibility of the site Investigator to discontinue a subject’s participation when the 
subject’s health or wellbeing is threatened by continuation in the study.   
For any subjects who withdraw from the study, the date and reason for withdrawal should be 
recorded on the eCRF.  If an AE or ISR is ongoing at the time of the withdrawal, the 
Investigator will attempt to follow the subject until the AE or ISR has resolved or stabilized.  
8.2.1 
Withdrawal Criteria 
The following circumstances shall result in a subject’s discontinuation from the study:  
• the subject undergoes repeat treatment other than Touch-up at Day 14 or study 
retreatment 
• If subject is administered any of the prohibited procedures listed as exclusionary in 
Section 4.3 
• Subject is lost to follow-up.  Subjects may be withdrawn if they do not return for 
follow-up visits.  If a subject fails to return for one or more scheduled study visits, the 
Investigator will attempt to contact the subject to determine and document the reason the 
subject has failed to return and to encourage compliance with the study visit schedule. 
 
The following circumstances may result in a subject’s discontinuation from the study: 
• AEs or serious adverse events (SAEs) that render the subject unable to continue study 
participation 
• Protocol violation 
• Non-compliance with study requirements  
• Discretion of Investigator (must document reason on eCRF)  
• Progressive injury (at the discretion of the Investigator)  
• There are changes in the subject’s condition that render the subject unacceptable for 
further participation in the judgment of the Investigator  
• A subject is unable to physically or mentally tolerate the use of the test treatment 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 40 
9 
ADVERSE EVENTS 
Throughout the course of the study (from the date of informed consent), all AEs will be 
monitored and recorded in source documents and on the AE eCRF.  If an AE occurs, the first 
concern will be the safety of the study participant.  All AEs related to study treatments or 
procedures will be followed until resolved or stabilized based on the Investigator’s clinical 
judgement. 
9.1 
DEFINITIONS   
9.1.1 
Adverse Events (AE) 
The reference safety data will be the current VOLIFT with Lidocaine instructions for use. 
According to EN ISO 14155:2011 an AE is any untoward medical occurrence, unintended 
disease or injury, or untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the investigational medical device 
or the comparator device. 
NOTE 1: This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
Adverse advents are collected once informed consent has been obtained, regardless of 
whether or not the subject has been administered study treatment.  Disease signs and 
symptoms that existed prior to the study treatment are not considered AEs unless the 
condition recurs after the subject has recovered from the pre-existing condition or the 
condition worsens in intensity or frequency during the study. 
All AEs ongoing at the exit visit must be followed until resolved or stable, based on the 
investigator’s clinical judgment. 
9.1.2 
Serious Adverse Events (SAE) 
According to EN ISO 14155:2011 an SAE is an AE that: 
• Led to death,  
• Led to a serious deterioration in the health of the subject that  
- 
resulted in a life-threatening illness or injury, or 
- 
resulted in a permanent impairment of a body structure or a body function, or 
- 
required in-subject hospitalisation or prolongation of existing hospitalisation, 
or 
- 
resulted in medical or surgical intervention to prevent permanent impairment 
to body structure or a body function. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 41 
• Led to foetal distress, foetal death or a congenital abnormality or birth defect. 
NOTE: Planned hospitalisation for a pre-existing condition, or a procedure required by the 
CIP, without serious deterioration in health, is not considered an SAE. Allergan considers all 
cancer AEs as SAEs.  Abortion is also considered an SAE except for elective abortion of a 
normal fetus. 
 (See Section 9.3: Procedures for Reporting an SAE/SADE). 
Any pre-planned surgery or procedure should be clearly documented in the site source 
documents by the medically qualified Investigator at the time of the subject’s entry into the 
study.   
9.1.3 
Adverse Device Effect (ADE) 
According to EN ISO 14155:2011 any AE related to the use of an investigational medical 
device, including those events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational 
medical device. 
NOTE 1: This definition includes AEs resulting from insufficient or inadequate instructions 
for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or from intentional 
misuse of the investigational medical device. 
9.1.4 
Serious Adverse Device Effect (SADE) 
According to EN ISO 14155:2011 a SADE is an ADE that resulted in any of the 
consequences characteristic of an SAE or that might have led to an SAE if  
a) suitable action had not been taken, or 
b) intervention had not been made, or  
c) circumstances had not been less fortunate. 
SADEs will be handled under the SAE reporting system. 
9.1.5 Unanticipated Serious Adverse Device Effect (USADE)  
According to EN ISO 14155:2011 a USADE  is a serious adverse device effect which by its 
nature, incidence, severity or outcome has not been identified in the current version of the 
risk analysis report 
NOTE: Anticipated serious adverse device effect (ASADE) is an effect which by its nature, 
incidence, severity or outcome has been identified in the risk analysis report. 
9.1.6 
Device Deficiency 
A device deficiency is defined in accordance with ISO 14155 as “inadequacy of a medical 
device with respect to its identity, quality, durability, reliability, safety, or performance.” 
Device deficiencies include malfunctions, use errors, and inadequate labeling. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 42 
If a device deficiency occurs, the Investigator will notify the Sponsor by email at the email 
address provided on the cover page of this protocol.  Allergan shall review all device 
deficiencies and determine/document in writing whether they could have led to a SADE. 
These shall be reported to the regulatory authority as required by national regulations.  
9.1.7 
Injection Site Reaction (ISR) 
ISRs following treatment with dermal fillers include redness, pain after injection, tenderness 
to touch, firmness, swelling, lumps/bumps, bruising, itching, discoloration, and other 
specified events.  Subjects will maintain a diary record of the presence, location, frequency, 
severity, and duration of any ISR for 30 days after treatment (initial and Touch-up).  (See 
Section 7.1.7: Injection Site Reaction (ISR) 30-Day Diary for further details). 
ISRs that persist longer than 30 days (i.e., ongoing at the end of the diary period) will be 
reported as AE and followed as described in Section 9.2: Procedure for Reporting Adverse 
Events.  If an ISR is ongoing or appears 30 days after the patient’s last study visit, it will be 
followed up by Allergan Product Surveillance separate from this study protocol. 
9.1.8 
Incident  
The Medical Device Directive (MDD) article 10 and MED DEV defines an incident as: any 
malfunction or deterioration in the characteristics and/or performance of a device, as well as 
any inadequacy in the labelling or the Instructions for use which, directly or indirectly, led to 
or might have led to the death of a subject, or USER or of other persons or to a serious 
deterioration in their state of health (see definition of SAE). 
As per applicable Medical Device Guidance Document, MEDDEV 2.12-1 rev. 8, all events 
that the Sponsor determines fulfil the criteria of incidence must be reported to applicable 
Competent Authorities (CAs). 
 
9.2 
PROCEDURE FOR REPORTING ADVERSE EVENTS 
All AEs and ADEs must be recorded in source documents and on the appropriate eCRF.  All 
AEs that are related and unexpected (not listed as treatment-related in the current package 
insert or Directions for Use) must be reported as required by the ethics committee, local 
regulations, and the governing health authorities. 
9.2.1 
Timelines for Reporting 
The Investigator is to adhere to the following schedule (Table 9.1) in reporting different 
types of AEs. 
Table 9.1 
Adverse Events Reporting Timelines 
Adverse Event Type 
Reporting to Allergan 
Start of Collection 
End of Collection 
AEs, ADEs 
Record on AE eCRF upon 
awareness for 
review by the Clinical Monitor 
Immediately after IC 
signed 
 
last subject visit 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 43 
SAEs, SADEs 
Record on SAE Form and fax / e-
mail to Allergan 
within 24 hours of awareness 
Immediately after 
IC signed 
 
30 days after last subject 
visit 
 
9.2.2 
Severity 
The Investigator will determine the severity classification based on the following definitions, 
his/her experience in the use of dermal fillers and/or the subject’s description of the event.  
ISR severity is defined on the ISR 30-Day Diary. 
The term “severe” is used to describe the intensity of an AE; the event itself could be of 
relatively minor clinical significance (e.g., ‘severe’ headache).  This is not the same as 
“serious”.  Seriousness of AEs is defined in Section 9.1.2: Serious Adverse Events (SAE). 
Severity will be assessed as: 
- Mild 
The AE does not interfere in a significant manner with the 
subject’s normal functioning level. It may be an annoyance. 
- Moderate 
The AE produces some impairment of function but not 
hazardous to health. It is uncomfortable and/or an 
embarrassment.  
- Severe 
The AE process significant impairment of functioning or 
incapacitation and/or it is a hazard to the subject. 
If an AE changes in severity, the worst severity should be reported. 
 
 
9.2.3 
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 a determination is made 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. 
Relationship to the device or procedure must be determined by the Investigator and cannot be 
delegated to other study staff. 
Causality will be assessed as: 
01 Not related: relationship to the device or procedures can be excluded when: 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 44 
- 
the event is not a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- 
the event has no temporal relationship with the use of the investigational device or the 
procedures. 
- 
the serious event does not follow a known response pattern to the medical device (if 
the response pattern is previously known) and is biologically implausible; 
- 
the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious event; 
- 
the event involves a body-site or an organ not expected to be affected by the device or 
procedure; 
- 
the serious event can be attributed to another cause (e.g. an underlying or concurrent 
illness/ clinical condition, an effect of another device, drug, treatment or other risk 
factors); 
- 
the event does not depend on a false result given by the investigational device used 
for diagnosis, when applicable; 
- 
harms to the subject are not clearly due to use error; 
- 
in order to establish the non-relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the serious event. 
02 Unlikely: the relationship with the use of the device seems not relevant and/or the event 
can be reasonably explained by another cause, but additional information may be obtained. 
03 Possible: the relationship with the use of the investigational device is weak but cannot be 
ruled out completely. Alternative causes are also possible (e.g. an underlying or concurrent 
illness/ clinical condition or/and an effect of another device, drug or treatment). Cases were 
relatedness cannot be assessed or no information has been obtained should also be classified 
as possible. 
04 Probable: the relationship with the use of the investigational device seems relevant and/or 
the event cannot reasonably explained by another cause, but additional information may be 
obtained.  
05 Causal relationship: the serious event is associated with the investigational device or 
with procedures beyond reasonable doubt when: 
- 
the event is a known side effect of the product category the device belongs to or of 
similar devices and procedures; 
- 
the event has a temporal relationship with investigational device use/application or 
procedures; 
- 
the event involves a body-site or organ that the investigational device or procedures 
are applied to; 
- 
the investigational device or procedures have an effect on; 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 45 
- 
the serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
- 
the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
- 
other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled out; 
- 
harm to the subject is due to error in use; 
- 
the event depends on a false result given by the investigational device used for 
diagnosis, when applicable; 
- 
in order to establish the relatedness, not all the criteria listed above might be met at 
the same time, depending on the type of device/procedures and the serious event. 
 
9.2.4 
Pregnancy 
If a female of childbearing potential becomes pregnant during the study, the Investigator will 
notify the Sponsor immediately by completing the Pregnancy Surveillance Form after the 
pregnancy is confirmed.  The Investigator shall (1) instruct the subject to notify her physician 
of the presence of the medical device and (2) follow the progress of the pregnancy to term. 
Pregnancy by itself will not be considered an AE or serious adverse event (SAE).  
Hospitalization for a normal delivery does not constitute an SAE.  However, the occurrence 
of an adverse pregnancy outcome for the mother or child may constitute an AE or SAE, and 
these should be reported as described in Section 9.2: Procedure for Reporting Adverse 
Events.  Allergan considers any abortion (spontaneous or not spontaneous) as a SAE and 
should be reported as described in Section 9.3: Procedures for Reporting an SAE/SADE. 
9.3 
PROCEDURES FOR REPORTING AN SAE/SADE 
The investigator is required to document AEs (non-serious and serious), device deficiencies, 
and incidents that occur during the duration of the study on the forms provided by Allergan. 
All SAEs, device deficiencies, and incidents from consent to 30 days after the last treatment, 
or last study visit (whichever is later) are to be immediately (within 24 hours) reported to 
Allergan.  
All subjects with a SAE, device deficiency, and incident must be followed up and the 
outcomes reported.  The investigator is to supply Allergan and the EC with any additional 
requests for information.   
An AE that continues beyond the end of the study final database lock will be followed 
independently from this study by the relevant Allergan safety department.  

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 46 
Both the investigator and Allergan will comply with all Medical Device Reporting 
requirements.   

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 47 
10 STATISTICAL METHODS   
10.1 GENERAL STATISTICAL CONSIDERATIONS 
A brief summary of the general statistical analysis methods is provided below; full details 
will be provided in a separate Statistical Analysis Plan (SAP), which will be finalized prior to 
database lock.  
Data will summarized using descriptive statistics (number of observations (n), mean, 
standard deviation (SD), median, minimum, and maximum for continuous variables; and n 
and percent for categorical variables. 
Baseline is defined as the latest assessment prior to any study treatments for each subject.  
End of study is the last clinical visit an enrolled subject has in this study.  For subjects who 
complete this study, the end of study visit will be their V5 visit; for subjects who drop out 
early, they will be asked to come back for the last clinical visit for end of study data 
collection. 
10.1.1 
Analysis Populations 
The following analysis populations will be used: 
1. Full Analysis Set:  Consists of all subjects who were consented and enrolled into this 
study and treated with the investigational product Juvederm VOLIFT with Lidocaine 
during the study. 
2. Safety Analysis Set: Identically defined as the Full Analysis Set. 
3. Evaluable Set: Consists of subjects in the Full Analysis Set who have had at least a 
baseline and a Day 30 (Visit 3) post-treatment efficacy assessment. 
4. Per Protocol Set: Consists of subjects in the Evaluable Set who had not had any 
major protocol deviations.   
 
10.1.2 
Subgroups  
As males and females may have differing expectations / perceptions of aesthetic 
improvement, data will be analysed by gender separately. 
Additional subgroup analysis will be discussed in the study SAP. 
10.2 DEMOGRAPHICS AND BASELINE CHARACTERISTICS 
Subject disposition, demographics and baseline characteristics will be summarized using 
descriptive statistics. 
10.3 EXPOSURE AND CONCOMITANT THERAPIES 
Subject study product exposure and compliance will be summarized using descriptive 
statistics. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 48 
The latest version of the World Health Organization Drug Dictionary will be used to classify 
prior and concomitant medications and therapies by therapeutic class and drug/device name. 
Prior medication/therapy is defined as those started by enrolled subjects before the date of 
first study treatment.  Concomitant medication/therapy is defined as those taken on or after 
the date of first treatment.  Prior and concomitant medications/therapies will be summarized 
using descriptive statistics.  
10.4 STUDY ENDPOINTS 
10.4.1 
Primary Endpoint 
The primary endpoint will be the responder rate for lip fullness on the LFS2, which is 
defined as the proportion of subjects who show ≥ 1-point improvement on the LFS2 
compared to baseline assessment, at Day 30 after last treatment received.  
10.4.2 
Secondary Endpoints 
10.4.2.1 
Oral Commissures Severity Scale (OCSS) 
Change from baseline in OCSS will be determined at each post-treatment visit. 
10.4.2.2 
FACE-Q – Satisfaction with Lips Questionnaire 
• Subject’s assessment of satisfaction with treatment of their lips as measured by the 
change from baseline in the FACE-Q Satisfaction with Lips questionnaire at all post-
treatment visits. 
10.4.2.3 
Global Aesthetic Improvement Scales (GAIS) 
• Investigator’s assessment of global facial aesthetic improvement as measured by the 
5-point GAIS at post-treatment visits beginning at Day 30 after last treatment received. 
• Subject assessment of global facial aesthetic improvement as measured by the 5-point 
GAIS at post-treatment visits beginning at Day 30 after last treatment received. 
10.4.2.4 
Natural Look and Feel/Product Smoothness/Dynamic lip lines  
• Subject’s assessment of natural look and feel of their lips as measured by the 5-point 
Likert scale at post-treatment visits beginning at Day 30 after last treatment received. 
• Investigator’s assessment of product smoothness as measured by the 5-point Likert scale 
at post-treatment visits beginning at Day 30 after last treatment received. 
• Investigator assessment of dynamic lip lines upon animation at post-treatment visits 
beginning at Day 30 after last treatment received 
10.5 EFFICACY ANALYSES 
Unless stated otherwise, all efficacy analyses will compare post-treatment assessment values 
to the subject’s corresponding baseline assessment value. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 49 
10.5.1 
Primary Efficacy Analysis 
The primary efficacy endpoint is the responder rate for lip fullness on the LFS2, which is 
defined as the proportion of subjects who show ≥ 1-point improvement on the LFS2 
compared to baseline assessment, at Day 30 after last treatment received.   
10.5.2 
Analysis of All Other Efficacy endpoints 
Details of the analyses for all other efficacy endpoints will be documented in the SAP. 
10.5.3 
Missing Data 
Missing data strategy will be documented in the study SAP.  
10.5.4 
Adverse Events 
Adverse events (AEs) will be coded using MedDRA version 20.1 or higher, and presented by 
System Organ Class (SOC) and Preferred Term (PT).  Treatment-emergent AEs will also be 
summarized by serious AEs (SAE), AE severity, AE leading to treatment or study early 
termination, and relationship to study drugs/devices.  
10.6 INTERIM ANALYSES AND DATA MONITORING 
 An interim analysis will be performed when all patients complete their 6 months visit (or 
discontinue early), full details will be described in the SAP. 
10.7 DETERMINATION OF SAMPLE SIZE 
It is expected that the responder rate for this study is approximately 80% based on the results 
of a pivotal study of a similar investigational product Juvéderm Volbella XC.   
 
   The margin of error (associated with 95% 
CI) for estimating an 80% expected responder rate is 10%, which is desirable to attain by 
having a sample size of 60 subjects for the study. Patients’ dropout rate is expected to be 
negligibly small at Day 30 post-treatment when the primary efficacy assessment is collected, 
thus 60 subjects will be recruited into the study. 
10.8 CHANGES IN THE CONDUCT OF THE STUDY OR PLANNED 
ANALYSIS 
Any changes to the conduct or planned analyses will be handled via protocol or SAP 
amendment, respectively. 
11 REGULATORY, ETHICAL, AND LEGAL OBLIGATIONS 
11.1 DECLARATION OF HELSINKI 
The Investigator will ensure that this study is conducted in accordance with the most recent 
revision of the Declaration of Helsinki. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 50 
11.2 GOOD CLINICAL PRACTICE  
The study will be conducted according to the study protocol and to the principles of good 
clinical practice ISO14155:2011.  
11.3 INDEPENDENT ETHICS COMMITTEES 
Before implementing this study, the protocol, the proposed subject informed consent forms, 
and other information for the subjects must be reviewed by a properly constituted committee 
or committees responsible for approving clinical studies.  The IEC written, signed approval 
letter/form must contain approval of the designated Investigator, the protocol (identifying 
protocol title, date and version number), the subject informed consent form (date, version), 
and any other subject facing documents. 
11.4 REGULATORY AUTHORITY APPROVAL 
The study is utilizing all products as per their licensed usage and indications.  Regulatory 
approval will be in place as required by participating countries.  
11.5 PROTOCOL COMPLIANCE 
The Investigator is responsible for compliance with the protocol at the investigational site. 
The Investigator is also responsible for reporting all issues of protocol non-compliance to the 
respective IEC and to the Sponsor.  A representative of the Sponsor will make frequent 
contact with the Investigator and his/her research staff and will conduct regular monitoring 
visits at the site to review subject and study device accountability records for compliance with 
the protocol, e.g., subject eligibility criteria, volume of product injected, procedures 
performed, and follow-up visit schedule. 
11.6 INFORMED CONSENT 
Written informed consent is to be obtained from the subject prior to any study-related 
procedures or change in treatment.  Privacy-related documentation will also be obtained from 
each subject prior to enrolment into the study, in accordance with relevant country and 
applicable local privacy requirements. 
All subjects will be required to participate in the consent process.  During the consent 
process, the person obtaining consent will inform the subject of all elements of informed 
consent.  The Investigator must ensure that the subject is given full and adequate oral and 
written information about the nature, purpose, possible risk and benefit of the clinical trial.  
Subjects must also be notified that they are free to withdraw from the clinical trial at any time 
without prejudice to future care.  The subject should be given the opportunity to ask 
questions and allowed time to consider the information provided.   
If the ICF is revised for any reason (e.g., protocol amendment or new safety data), the revised 
ICF must be reviewed and approved by the IEC.  The revised ICF is not considered effective 
until approved by the IEC.  All subjects currently enrolled in the clinical trial must sign the 
revised ICF.  Subjects enrolled in the clinical trial after the revised ICF has been approved by 
the IEC will sign the revised version. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 51 
11.7 SUBJECT CONFIDENTIALITY AND DISCLOSURE 
A report of the results of this study may be published or sent to the appropriate health 
authorities as appropriate but the subject’s name will not be disclosed in these documents.  
The subject’s name may be disclosed to the Sponsor of the study, Allergan, or the governing 
health authorities if they inspect the study records.  Appropriate precautions will be taken to 
maintain confidentiality of medical records and personal information. 
11.8 SPONSOR MONITORING OF STUDY DOCUMENTATION 
A representative of the Sponsor will monitor the study on a periodic basis.  The 
determination of the extent and nature of monitoring will be based on considerations such as 
the objective, purpose, design, complexity, size, and endpoints of the study.  This will be 
detailed in the Study Monitoring Plan.  
Authorized representatives of Allergan or regulatory authority representatives will conduct 
on-site visits to review, audit and copy study-related documents.  These representatives will 
meet with the Investigator(s) and appropriate staff at mutually convenient times to discuss 
study-related data and questions. 
11.9 STUDY DOCUMENTS 
The Investigator must maintain source documents for each subject in the study, including all 
demographic and medical information etc., and keep a copy of the signed and dated informed 
consent forms.  All information on the eCRFs must be traceable to these source documents in 
the subject’s file. 
11.10 COLLECTION OF STUDY DATA 
The Investigator is responsible for ensuring that study data are properly recorded on each 
subject’s eCRFs and related documents.  An Investigator who has signed the protocol 
signature page should sign off for the eCRFs (as indicated in the eCRFs) to attest that the 
observations and findings are recorded on the eCRFs correctly and completely.  The eCRFs 
are to be submitted to Allergan in a timely manner at the completion of the study, or as 
otherwise specified by Allergan. 
The data reported on the eCRFs shall be derived from source documents and be consistent 
with these source documents, and any discrepancies shall be explained in writing.  Any 
change or correction to data reported on an eCRF shall be dated, initialed and explained, if 
necessary, and shall not obscure the original entry (i.e., an audit trail shall be maintained); 
this applies to both written and electronic changes and corrections. 
11.11 ARCHIVING OF STUDY DOCUMENTS 
All study-related correspondence, subject records, consent forms, subject privacy 
documentation, records of the distribution and use of all products, and copies of eCRFs 
should be maintained on file.  Allergan-specific essential documents are to be retained for a 
period of at least 10 years after the last device covered by the EU declaration of conformity 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 52 
has been placed on the market. These documents are to be retained for a longer period, 
however, if required by the applicable regulatory requirements or if needed by Allergan. 
11.12 DISCLOSURE OF INFORMATION 
This study will be registered and results posted on www.clinicaltrials.gov.  Allergan, as the 
Sponsor, has proprietary interest in this study.  Authorship and manuscript composition will 
reflect joint cooperation between study Investigators and Allergan personnel.  Authorship 
will be established prior to the writing of the manuscript.  As this study involves multiple 
centers, no individual publications will be allowed prior to completion of the final report of 
the multicenter study except as agreed with Allergan. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 53 
12 REFERENCES 
1. Bogle MA, Arndt KA, Dover JS, Kaminer MS. (2009). Evaluation of the Aging Face. In 
Kaminer MS, Arndt KA, Dover JS, Rohrer TE, Zachary CB, Atlas of Cosmetic Surgery 
(2nd ed., pp. 37-43). Philadelphia, PA: Saunders Elsevier. 
2. Gupta MA, Gilchrest BA. Psychosocial Aspects of Aging Skin. Dermatol Clin 2005; 
23:643-648. 
3. Byrne PJ, Hilger PA. Lip augmentation. Facial Plast Surg. 2004; 20(1):31-38. 
4. Carruthers A, Carruthers JDA. Polymethylmethacrylate microspheres/collagen as a tissue 
augmenting agent : personal experience over 5 years. Dermatol Surg.2005; 31:1561-
1565. 
5. Brandt FS, Cazzaniga A. Hyaluronic acid gel fillers in the management of facial aging. 
Clin Intervent Aging. 2008;3(1):153-9. 
6. Gordon RW. Beyond the teeth: framing your patient's beautiful smile. Dent Today. 
2008;27(10):174-7. 
7. Allemann IB, Baumann L. Hyaluronic acid gel (JUVÉDERMTM) preparations in the 
treatment of facial wrinkles and folds. Clin Intervent Aging. 2008;3(4):629-34. 
8. Bergeret-Galley C. Choosing injectable implants according to treatment area: the 
European experience. Fac Plast Surg. 2009;25:135-42. 
9. Fitzpatrick TB. The validity and practicality of sun reactive skin type I through VI. Arch 
Dermatol. 1988;124:869-871. 
10. Sarnoff DS, Saini R, Gotkin RH. Comparison of filling agents for lip augmentation. 
Aesth Surg. 2008;28(5):556-63. 
11. Wesley NO, Dover JS. The filler revolution: a six-year retrospective. J Drugs Dermatol. 
2009. 8;(10):903-7. 
12. Segall L, Ellis D. Therapeutic options for lip augmentation. Fac Plast Surg Clin N Am. 
2007; 15:485-490. 
13. Downie J, Mao Z, Tsz-Wai RL, Barry S, Bock M, Siebert JP, Bowman A, Ayoub A. A 
double-blind, clinical evaluation of facial augmentation treatments: a comparison of PRI 
1, PRI 2, Zyplast and Perlane. J Plast Recon & Aesth Surg. 2009;62(12):1636-43. 
14. Fagien S, Maas C, Thomas J, Murphy D, Beddingfield F. Juvéderm® Ultra for lip 
enhancement: An open-label, multicenter study. Poster presented at the 2009 meeting of 
the American Society for Aesthetic Plastic Surgery (ASAPS); Las Vegas, NV. 
15. Lanigan S. An observational study of a 24 mg/mL hyaluronic acid with preincorporated 
lidocaine for lip definition and enhancement. J Cosmet Dermatol 2011; 10:11-14. 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 54 
16. Andre P. New trends in face rejuvenation by hyaluronic acid injections. J Cosmetic 
Dermatol. 2008; 7:251-258.Rivkin A. New fillers under consideration: What is the future 
of injectable aesthetics? Facial Plast Surg 2009; 25:120-123. 
17. Gold M. The science and art of hyaluronic acid dermal filler use in esthetic applications. 
J Cosmet Laser Therapy 2009; 8(4): 301-307. 
18. Raspaldo H, De Boulle K, Levy P. Comparative trial of a cohesive hyaluronic acid filler 
formulated with and without lidocaine: Evaluation and confirmation of longevity. Poster 
presented at the 7th Annual Meeting of the Anti-Aging Medicine World Congress 
(AMWC), Monte-Carlo, Monaco, March 19-21, 200 
19. Rivkin A. New fillers under consideration: What is the future of injectable aesthetics? 
Facial Plast Surg 2009; 25:120-123. 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 55 
13 APPENDICES  

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 56 
APPENDIX 1 
JUVEDERM® VOLIFT™ WITH LIDOCAINE DFU 
 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 57 
 
 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 58 
 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 59 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 60 
APPENDIX 2 
INJECTION SITE REACTION (ISR) 30-DAY DIARY 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 62 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 64 
APPENDIX 3 
LIP FULLNESS SCALE 2 (LFS2) 
 
 
 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 65 
APPENDIX 4 
ORAL COMMISSURE SEVERITY SCALE (OCSS) 
 
 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 66 

JUVÉDERM® VOLIFT™ WITH LIDOCAINE 
Allergan 
 
Clinical Study Protocol: CMO-MA-FAS-0512 
 
 
 
 
 
 
VERSION 3, 10 OCTOBER 2019  
 
Page 70 
APPENDIX 9 
PERIORAL LINES AT REST SEVERITY SCALE (POLSS)