A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multicenter Study to Evaluate Effectiveness and Safety of Restylane Lyft Lidocaine for Jawline Definition
Phase: NA
Conditions: Jawline Definition
Sponsor: Galderma R&D

CONFIDENTIAL
Page 1 of 67
CLINICAL STUDY PROTOCOL
PROTOCOL NUMBER: 05DF2209
This document contains confidential, proprietary information
This clinical study protocol contains confidential information belonging to Galderma R&D, LLC and Q-Med AB, part 
of the Galderma Group. Except as may be otherwise agreed to in writing, by accepting or reviewing these materials, you 
agree to hold such information in confidence and neither disclose it to any third parties (except where required by 
applicable law) nor use it for any other purpose than in relation to the clinical study described herein. No information 
may be disclosed to any third party without prior written consent from Galderma R&D, LLC or Q-Med AB.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 2 of 67
TITLE PAGE
A randomized, evaluator-blinded, parallel group, no treatment controlled, 
multicenter study to evaluate effectiveness and safety of Restylane Lyft 
Lidocaine for jawline definition.
Clinical Trial Number (CTN): 05DF2209
SPONSOR:
Q-Med AB
Seminariegatan 21
SE-752 28 Uppsala, Sweden
Telephone: +46 18 474 90 00
Galderma Research and Development, LLC
2001 Ross Avenue, Suite 1600
Dallas, TX. 75201
United States
Telephone: +1 817 961 5000
Statements of compliance
The study should be conducted in compliance with the clinical trial agreement, the clinical study protocol, good clinical 
practice (GCP), and applicable regional or national regulations. The international standard for clinical study of medical 
devices for human subjects, ISO14155:2020 should be followed. The International Conference on Harmonisation (ICH) 
guideline for GCP (E6 (R2)) should be followed as applicable for medical device. The study should be conducted in 
accordance with the ethical principles that have their origin in the Declaration of Helsinki1.
                                                
1 (https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ )
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 4 of 67
SYNOPSIS
Clinical Study Title:
A randomized, evaluator-blinded, parallel group, no treatment 
controlled, multicenter study to evaluate effectiveness and safety of 
Restylane Lyft Lidocaine for jawline definition.
Clinical Trial Number:
05DF2209
Country involved and 
Planned Number of Study 
Centers:
Canada
No. of Study Centers: Approximately 10
Clinical Study Design:

A prospective, randomized, evaluator-blinded, no treatment 
controlled, parallel group, multicenter phase IV study to 
evaluate effectiveness and safety of Restylane Lyft Lidocaine
for jawline definition.

Treatment in accordance with approved Instructions for Use in 
Canada.

Approximately 140 subjects will be included in the study. 

Eligible subjects randomized to receive treatment will be 
injected by the Treating Investigator at Day 1. A follow-up 
telephone call should be made 72 hours after treatment.

Optional touch-up treatment may be administered 1 month (4 
weeks) after initial treatment, if deemed necessary by Treating 
Investigator and the subject to obtain optimal aesthetic 
improvement. If optional touch-up is performed, a 72-hour 
follow-up telephone call and follow-up visit after 1 month
should be scheduled.

Effectiveness and safety data will be collected for up to 12 
months (48 weeks) after the last treatment including follow up 
visits at 1, 3, 6, 9 and 12 months.

Subjects in the No Treatment group will be offered optional 
treatment after 12 months from baseline (Day 1) followed by 
a safety assessment 2 weeks after the optional treatment. 
Subjects who decline treatment after 12 months will end their 
study participation.

Investigator blinding will be accomplished by having a 
Treating Investigator administer the treatments and having a 
Blinded Evaluator, to whom randomization and treatment are 
concealed, conduct blinded assessments. Safety assessments 
will be performed by non-blinded personnel.
Indication:
Restylane Lyft Lidocaine is an injectable implant, intended to be used
for jawline treatment within the approved indication (i.e., facial tissue 
augmentation) in adults.
Total Number of Subjects 
(Planned):
Approximately 140 subjects will be randomized (3:1) to Treatment or 
to No Treatment group.
Effectiveness Objectives and 
Endpoints:
The primary objective of the study is to assess the effectiveness of 
Restylane Lyft Lidocaine versus a no treatment control in jawline 
definition by comparing Galderma Jawline Scale (GJS) response rates.
Primary Endpoint:
Responder rate based on the Blinded Evaluators’ live assessment of the 
GJS at 3 months after last treatment for the Treatment group or after 
baseline for the No Treatment group.
A responder is defined as a subject with at least 1-point improvement from 
baseline, on both jawlines concurrently.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 9 of 67
Accounting for 10% dropouts, approximately 140 subjects need to be 
randomized in a 3:1 ratio.
Interim Analysis:
No formal interim analysis will be performed. However, analysis of 
data could take place at a time point after the last collection of primary 
endpoint data.
Effectiveness Assessments

Blinded Evaluator GJS

Treating Investigator GJS (for assessing subject treatment 
needs only)

Treating Investigator GAIS

Subject reported GAIS
 
Safety Assessments

Adverse Event reporting: AEs will be obtained from signs and 
symptoms reported by the subject or detected during each 
examination. 

A subject diary will be dispensed to the Treatment group for 
daily completion over the first 28 days after each treatment to
record the following pre-identified symptoms: bruising, 
redness, pain, tenderness, lumps/bumps, itching, swelling and 
other. Information from the diary will be presented separately 
from other AEs.

Device deficiencies will be assessed at treatment visits.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
C
C
I

CONFIDENTIAL
Page 11 of 67
SCHEDULE OF EVENTS 
Table 1
Schedule of events – Treatment group
Procedure
Visit 1
Visit 2
Visit 2a
Visit 3
Visit 3a4
Visit 3b4
Visit 4
Visit 5-6
Visit 7
Day -21 to 1
Day 1
72 hrs after 
Tx
(±24 hrs)
1 month after 
Tx
(+7 days)
72 hrs after 
optional TU 
(±24 hrs)
1 month
after 
optional TU
(+7 days)
3 months after 
last treatment 
(±14 days)
6 and 9 months
after last 
treatment
(±14 days)
12 months after last 
treatment
(±14 days)
Screening
Baseline/
Tx
TC
Follow-up/
Optional TU
TC
Follow-up
Follow-up
Follow-up
Follow-up/ EOS
Informed Consent
X
Med. Hx/prior therapies
X
X1,2
Demographics
X
Height/Weight9
X1
X
Inclusion/Exclusion Criteria
X
X1,2
X1,5
Urine pregnancy test3
X
X1,2
X1,5
Randomization
X1
Treatment with study product
X
X5
Evaluate device deficiencies
X
X5
Dispense Subject Diary
X
X5
Collect/Review Subject Diary
X8
X
X8
X
Photography
X1
X1
X
X
X
X
Concomitant therapies
X
X2
X
X
X
X
X
X
X
Assessment of AEs
X
X
X
X
X
X
X
X
Treating Investigator Assessments
GAIS
X
X
X
Galderma Jawline Scale6
X
X1,2
X1,5
Blinded Evaluator Assessments
Galderma Jawline Scale
X
X1,2
X
X
X
Subject Assessments
GAIS
X
X
X
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
Version:
Effective date:
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI
CCI

CONFIDENTIAL
Page 13 of 67
1Omitted if the screening and baseline visits occur on Day 1. Screening visit and baseline visit can be combined if no drug washout is needed
2For females of childbearing potential
3Visit is scheduled only if optional treatment has been performed
4Omitted if optional treatment is not performed
5Prior to treatment
6Subject self-reported. Height only needs to be collected at baseline
7For assessing subject treatment needs only
AE = Adverse event
EOS = End of Study
GAIS = Global Aesthetic Improvement 
Scale
Tx = Treatment
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
Version:
Effective date:
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 14 of 67
ABBREVIATIONS AND DEFINITIONS OF TERMS
AE
Adverse Event 
Blinded evaluator
An evaluator responsible for independent evaluation of treatment result(s). 
The evaluator should be a Health Care Professional and must not be involved 
in the treatment of the subject.
BOCF
Baseline observation carried forward
Childbearing Potential
A female (including pre-menopausal subjects) capable of becoming 
pregnant; this includes women on oral, injectable, or mechanical 
contraception or women whose male partners have been vasectomized or are 
utilizing mechanical contraceptive devices
COX-2
Cyclooxygenase-2
CRO
Contract Research Organization
CTA
Clinical Trial Agreement
CTN
Clinical Trial Number
CSP
Clinical Study Protocol
CSR
Clinical Study Report
CV
Curriculum vitae
DBL
Database lock
Device deficiency
Inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety, or performance (includes malfunctions, use errors, and 
inadequate labelling)
DMP
Data Management Plan
eCRF
Electronic case report form
EOS
End of study
EU
European Union
FSFV
First subject first visit
FUP
Follow-up
GAIS
Global Aesthetic Improvement Scale
GCP
Good clinical practice
GDPR
General Data Protection Regulation, Regulation (EU) 2016/679
GJS
Galderma Jawline Scale
HA
Hyaluronic acid
HIV
Human Immunodeficiency Virus
hrs
Hours
ICF
Informed Consent Form
ICH
International Conference on Harmonisation
IFU
Instructions for Use
Investigational product
Medical device being assessed for safety or performance in a study. 
“Investigational product” is the same as “study device”, “investigational 
device”, or “investigational medical device.”
Institution
Any public or private entity or agency or medical or dental facility where a 
clinical study is conducted.
Investigator
The Principal Investigator (PI) or other qualified person, i.e., sub-
Investigator, designated and supervised by the PI at a study center to perform 
critical study-related procedures or to make important study-related decisions 
as specified on the signature and delegation log. An Investigator should be a 
Physician.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 15 of 67
Investigator file
Essential documents relating to a clinical study as defined in applicable GCP 
guidance document and maintained by the Investigator.
ISO
International Organization for Standardization
ITT
Intention-to-treat
LSLV
Last subject last visit (last subject who completed its last clinical study visit)
MedDRA
Medical Dictionary for Regulatory Activities
MDR
Medical Devices Regulation, Regulation (EU) 2017/745 on medical devices
mg
Milligram
mL
Milliliter
NSAID
Non-steroidal anti-inflammatory drug
OTC
Over-the-counter
PI
Principal Investigator; qualified person responsible for conducting the study 
at a study center
PP
Per Protocol
PT
Preferred term
q.s.
Quantum satis
RA
Regulatory Authority
REB
Research Ethics Board
SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SDV
Source data verification
SOC
System organ class
Sponsor file
Essential documents relating to a clinical study as defined in applicable GCP 
guidance document and maintained by the Sponsor.
Study center
Institution or site where the study is carried out
Study files
The Investigator file and the Sponsor file
Study products
The investigational product under study
TC
Telephone call
Treating Investigator
Qualified physician to perform the study injections, should be aware of 
important neurovascular and anatomical structures near injection sites.
TU
Touch-up (Repeated injection to be performed after treatment, if necessary 
to achieve optimal correction)
Tx
Treatment
UPT
Urine pregnancy test
WHO
World Health Organization
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 16 of 67
Table of Contents
TITLE PAGE
2
INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
3
SYNOPSIS
4
CLINICAL STUDY FLOW CHART
10
SCHEDULE OF EVENTS
11
ABBREVIATIONS AND DEFINITIONS OF TERMS
14
1.
BACKGROUND INFORMATION
20
Medical background, indication and population description
20
Relevant previous data
20
1.2.1
Non-clinical documentation
20
1.2.2
Clinical documentation
20
Risks and benefits
21
2.
STUDY OBJECTIVES, ENDPOINTS
22
Study objectives
22
2.1.1
Primary objective and endpoint
22
2.1.2
Secondary objective and endpoints
22
2.1.3
Safety objectives and endpoints
23
Appropriateness of measurements
23
3.
STUDY DESIGN
23
Overall design
23
Study rationale and justification for design
24
Number of subjects and investigational centers
24
Study duration
24
Procedures/reasons for subject discontinuation
25
Suspension or premature termination
26
4.
STUDY POPULATION
26
Clinical study population characteristics
26
4.1.1
Inclusion criteria
26
4.1.2
Exclusion criteria
27
Medical history
28
Previous and concomitant therapies
28
4.3.1
Definition
28
4.3.2
Categories
28
4.3.3
Authorized concomitant therapies
28
4.3.4
Prohibited concomitant therapies
28
4.3.5
Documentation and recording instructions
29
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 17 of 67
Subject identification number
29
5.
STUDY INTERVENTION
30
Description of the investigational device
30
5.1.1
Investigational device
30
5.1.2
Reference product
30
Additional products and materials
30
Packaging and labelling
30
Instructions for use and administration
30
5.4.1
Treatment procedure
30
5.4.1
Pre-Treatment procedure
31
5.4.2
Treatment regimen (dose and interval)
31
5.4.3
Post-treatment care
32
Supplies management
32
5.5.1
Product accountability
32
5.5.2
Storage of study product
33
5.5.3
Dispensing and return
33
5.5.4
Treatment compliance
33
Randomization
33
Blinding
33
5.7.1
Verification of blinding
33
5.7.2
Emergency unblinding
34
Post-trial provisions
34
6.
EFFECTIVENESS ASSESSMENTS
34
Effectiveness Assessment Methods
34
Photography
34
Galderma Jawline Scale (GJS)
34
Global Aesthetic Improvement Scale (GAIS)
35
7.
SAFETY ASSESSMENTS
36
General information
36
Subject Diary Data
36
Laboratory assessment
37
Adverse events
37
7.4.1
Anticipated adverse events
37
7.4.2
Assessment of severity
37
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 18 of 67
7.4.3
Assessment of causality
38
7.4.4
Action taken
39
7.4.5
Follow-up of adverse events
39
7.4.6
Documentation and recording instructions
40
Serious Adverse Events
40
Device deficiencies
41
Safety report procedures and timelines
41
7.7.1
Reporting of Serious Adverse Events
41
7.7.2
Pregnancy
42
7.7.3
Device deficiencies
43
7.7.4
Reporting of device deficiencies
43
8.
DESCRIPTION OF STUDY VISITS
44
Visit 1: Screening (Day-21-D1)
44
Visit 2: Baseline (Day 1, Initial Treatment)
44
8.2.1
Visit 2a: Follow up 72-hour (±24 hours) telephone call after initial treatment
45
Visit 3: Follow up visit 1 month (+ 7 days) after initial treatment / Optional touch-up or after 
baseline for the No Treatment group
46
8.3.1
Visit 3a: Follow up 72-hour (±24 hours) telephone call after optional touch-up performed
47
8.3.2
Visit 3b: Follow up visit 1 month (+ 7 days) after optional touch-up performed
47
Visit 4 to 6: Follow-up visits 3, 6 and 9 months (± 14 days) after last treatment or after baseline for 
the No Treatment group
47
Visit 7: Follow-up visit 12 months (± 14 days) after last treatment / after baseline for the No 
Treatment group
48
8.5.1
Visit 7a: Follow up visit 14 days (± 7 days) after optional treatment
49
9.
STATISTICAL DESIGN AND ANALYSIS
49
General
49
Analysis populations
49
Demographics, baseline assessments, and subject characteristics
50
Effectiveness analysis
50
Safety analysis
50
Handling of missing data
51
Interim analysis
51
Independent data monitoring committee
51
Withdrawals and deviations
51
Sample size
51
10.
ETHICS AND GENERAL CLINICAL STUDY CONDUCT
52
Ethical considerations
52
10.1.1
Statement of ethical compliance
52
10.1.2
Application to research ethics board and/or regulatory authorities
52
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 19 of 67
Subject information and consent
52
Personnel training
53
Data management and documentation
53
10.4.1
Data entry and collection
53
10.4.2
Source documentation
54
10.4.3
Protection of personal data
55
10.4.4
Archiving / record keeping
55
Protocol deviations
56
Quality control / quality assurance
56
10.6.1
Clinical Monitoring
56
10.6.2
Audits / inspections
56
Protocol amendments
56
10.7.1
Amendments
56
Financing, indemnification and insurance
56
Publication policy
57
11.
REFERENCES
58
12.
APPENDICES
59
APPENDIX 1
GALDERMA JAWLINE SCALE (GJS)
59
SIGNED AGREEMENT OF THE CLINICAL STUDY PROTOCOL
65
SPONSOR SIGNATURES
66
List of Tables
Table 1
Schedule of events – Treatment group.............................................................................11
Table 2
Schedule of events – No Treatment group.......................................................................12
Table 3
Investigator Global Aesthetic Improvement Scale (GAIS) .............................................35
Table 4: Fitzpatrick Skin Type (FST)..............................................................................................44
List of Figures
Figure 1
Study Flow Chart .........................................................................................................10
Appendix 1
Galderma Jawline Scale (GJS).................................................................................60
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI
CCI
CCI

CONFIDENTIAL
Page 20 of 67
1. BACKGROUND INFORMATION
Medical background, indication and population description
From an aesthetic perspective, the jawline contributes significantly to facial proportional appearance 
and is a critical component in the perception of facial attractiveness in both men and women. An 
attractive jawline constitutes a well-defined, straight jawline. Aging across the mandibular border 
may be described by several mechanisms: Fat atrophy and volume loss; shifting of subcutaneous fat 
compartments; and mandibular septum dehiscence with submandibular fat hypertrophy.1
With aging, bone recession, combined with mid-face laxity, may produce sagging skin below the 
jawline as the supporting systems diminish. In the lower face, this age-associated volume loss leads
to loss of definition of the jawline.2
Individuals are looking to create or enhance an attractive appearance by improving their natural 
definition of the jawline. In Europe, a consumer survey revealed that the jawline is a preferred 
feature to change for one-third of women aged 46-63 years.3
Further, enhancing to achieve a well-defined, "strong", masculine jawline is also desired by men.4
Rejuvenation of the jawline is becoming part of routine aesthetic practice with injectable dermal 
fillers containing hyaluronic acid or calcium hydroxylapatite (NCT03712137, NCT03425253, 
NCT04645576 and NCT03583359 registered on www.clinicaltrials.gov).
Restylane Lyft Lidocaine is intended to be used for facial tissue augmentation and is used for shaping 
the contours of the face. In this study, Restylane Lyft Lidocaine will be used for Jawline treatment 
within the approved indication. It should be injected into the deep layer of the dermis and/or the 
surface layer of the subcutis. Deeper injections into the subcutaneous fatty tissue or supraperiosteal 
layer are appropriate for areas with adequate soft tissue support and soft tissue cover such as the
midface and jawline (see the co-packed Instructions for Use (IFU)).
Lidocaine is added to the formulation of Restylane Lyft Lidocaine to diminish the pain resulting 
from the injection during the treatment.
The product is intended to be used only by authorized personnel, trained in the appropriate injection 
techniques, in accordance with local legislation. The study population consists of adult men and 
women meeting the inclusion/exclusion criteria.
Relevant previous data
1.2.1
Non-clinical documentation
Restylane Lyft Lidocaine is produced using the NASHA™ technology. The NASHA gels have been 
tested and meet all biocompatibility requirements specified in the International Organization for 
Standardization (ISO) 10993:1 Biological Evaluation of Medical Devices.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 21 of 67
1.2.2
Clinical documentation
Restylane Lyft Lidocaine has been evaluated in clinical studies and is approved for use in Canada 
since 2010. Please refer to the co-packed IFU for detailed information. The IFU summarizes the 
adverse effects experienced with hyaluronic acid (HA) injections along with precautions that can 
minimize these potential complications.
Risks and benefits
The primary potential benefit of treatment is a perceived aesthetic improvement of jawline definition
by facial tissue augmentation. Treatment with HA fillers are less invasive than surgical options and 
may offer less downtime from swelling and bruising. Adding volume in the jawline may improve 
subject satisfaction and restore youth by creating definition. HA fillers are becoming more popular 
for the treatment of jawline and have a good safety profile.
Injection site reactions (e.g., bruising, erythema, itching, swelling, pain or tenderness at the implant 
site) might occur. The resolution is spontaneous within a few days to a few weeks after injection 
into the skin.
The most common adverse events (AEs) reported in post-marketing surveillance data are swelling 
with immediate onset and onset up to several weeks after treatment.
Other
AEs 
such 
as 
bruising/hematoma, 
discoloration/hyperpigmentation, 
erythema,
papules/nodules, pain/tenderness and hypersensitivity/angioedema, inflammation, mass/induration, 
neurological symptoms and non-dermatological events have also been reported with short duration 
of effect.
Vascular compromise may occur due to an unintentional intravascular injection or as a result of 
vascular compression associated with implantation of any soft tissue filler in the face. This may 
manifest as blanching, discoloration such as a dusky or reticular appearance of the tissue, necrosis 
or ulceration at the implant site or in the area supplied by the blood vessels affected, or rarely as 
ischemic events in other organs due to embolization. Rare but serious cases of ischemic events 
associated with temporary or permanent vision impairment, blindness, cerebral ischemia or stroke
have been reported following facial aesthetic treatments.
Symptoms of inflammation at the implant site commencing either shortly after injection or after a
delay of up to several weeks have been reported. In case of unexplained inflammatory reactions 
infections should be excluded and treated, if necessary, since inadequately treated infections may 
progress into complications such as abscess formation. Treatment using only oral corticosteroids 
without concurrent antibiotic treatment is not recommended.
Post inflammatory pigmentation changes have been observed in clinical studies in people with dark 
skin (Fitzpatrick Type IV-VI).
Additional information about expected AEs and anticipated risks are included in the specific IFU.
To mitigate these risks, only study Investigators qualified by education and experience, who are 
skilled in the use of dermal fillers from their clinical practice and involvement in clinical research, 
and with knowledge of facial anatomy, understanding of the depth and plane of injection, as well as 
knowledge of the signs and symptoms and management of potential complications, will be chosen 
to participate in this study. This further ensures proper device implantation and management of study 
risk.
Given the anticipated low level of transient and acceptable AEs in connection with the injection, the 
protocol-required safety assessments, and the injection technique training provided, it was 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 25 of 67
Study duration
The total duration of the study is estimated to approximately 18 months. This includes 4 months 
recruitment period.

Treatment group:
o
Up to 21 days screening
o
Treatment at baseline (Day 1) and TC at 72 hrs after last treatment.
o
Optional touch-up at 1 month and TC at 72 hrs after last touch-up.
o
Data collection and safety follow-up visits at 1, 3, 6, 9 and 12 months after last treatment.

No Treatment Control group:
o
Up to 21 days screening
o
Data collection and safety follow-up visits at 1, 3, 6, 9 and 12 months after baseline.
o
Optional treatment at 12 months after baseline followed by 2 weeks safety follow-up after 
optional treatment.
One month is defined as 4 weeks in the study.
Procedures/reasons for subject discontinuation
An investigator may decide to discontinue a subject from the clinical study for safety reasons.
Although the importance of completing the entire clinical study should be explained to the subject 
by the clinical study personnel, any subject is free to discontinue participation in this clinical study 
at any time and for whatever reason, specified or unspecified, and without any prejudice. No 
constraints are to be imposed on the subject, and when appropriate, a subject may be treated with 
other conventional therapy when clinically indicated. 
When a subject does not complete the clinical study, he/she will be fully assessed if such 
assessment is possible. The procedures designated for the closest upcoming study visit should be 
completed for a subject discontinuing the clinical study and the appropriate electronic Case Report 
Form (eCRF) should be completed.
All discontinuations and the reason for discontinuation are to be documented by the investigator on 
the Study Exit form.
For discontinuation due to an AE, the Adverse Event form is to be completed. The investigator 
should also ensure that the subject receives suitable therapy for the AE.
A subject who has been randomized cannot be replaced by another subject if he/she discontinues the 
clinical study for any reason.
Pregnancies occurring during the screening period are considered as screening failures; they should 
be recorded as such in the eCRF and no pregnancy form is to be completed. 
In case of a pregnancy occurring after the baseline visit, follow the procedures described in section 
7.7.2. The subject may remain in the study, but no invasive procedure should be conducted.
The Sponsor may also decide to prematurely terminate or suspend a subject’s participation in the 
clinical study.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 26 of 67
Potential reasons for discontinuation are defined below:
The withdrawal criteria are:
Medical Reasons
If the subject suffers from a medical condition and/or Adverse Events 
that, in the judgment of the Investigator makes it medically necessary 
to withdraw the subject. The specific rationale for Investigator-
initiated withdrawal of a subject for medical reasons should 
document the specific condition for withdrawing the subject.
Withdrawal by 
Subject:
Includes consent withdrawal, subject relocation, schedule conflicts. 
A subject can withdraw their consent to participate in the study at 
their own request or be withdrawn from participation in the study at 
the request of their legally authorized representative at any time for 
any reason.
Lost to follow-up:
If a subject does not return for a scheduled visit, reasonable effort 
shall be made to contact that subject, confirm with three documented 
phone calls and a certified letter (delivery receipt requested) without 
answer before declaring the subject lost to follow-up.
Other:
This category is to be used for a subject who discontinues due to a 
reason other than as specified in the pre-defined categories above. 
Explain the reason for discontinuation.
If reason for discontinuation is “withdrawal by subject” or “other”, the subject will be questioned to 
rule out the possibility of an AE. If the AE led to discontinuation, then “Adverse Event” should be 
chosen as the reason for discontinuation, rather than “withdrawal by subject” or “other”.
If an AE which, according to the Investigator’s assessment, is related to the use of any of the study 
products and is still ongoing at the time of the withdrawal, the Investigator shall follow-up the 
subject until the AE resolves, is assessed by the Investigator to be “chronic” or “stable” or subject 
is lost to follow up. Follow-up information shall be reported on the AE follow-up form.
Suspension or premature termination
The Sponsor will suspend or terminate the study when so instructed by the Research Ethics Board 
(REB) or RA, or if it is judged that the subjects are subjected to unreasonable risks, or for valid 
scientific or administrative reasons, or for business reasons. The Sponsor may also decide to close a 
single study center due to unsatisfactory subject enrollment or non-compliance with the CSP, Good 
Clinical Practice (GCP), or applicable regulatory requirements. 
In the event of premature termination, the Sponsor will provide information on the handling of 
currently enrolled subjects who have not completed the study.
4. STUDY POPULATION
Approximately 140 adult male and female subjects with Grade 2 to 4 (moderate to very severe) on 
the GJS with the intent to undergo bilateral jawline treatment will be included in this study. 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 27 of 67
Clinical study population characteristics
4.1.1
Inclusion criteria
1. Male and female adults willing to comply with the requirements of the study and providing 
a signed written informed consent.
2. Consent the use of facial images for marketing purposes and educational material as 
described in the Informed Consent Form (ICF).
3. Subject with moderate to very severe (Grade 2 to 4) on the Galderma Jawline Scale (GJS) 
with no more than one grade difference between the left and right side at baseline as assessed 
by the Blinded Evaluator.
4. Subject is willing to abstain from any other facial, submental, and/or neck aesthetic 
procedure(s) or implant for the duration of the study.
5. Female of childbearing potential with a negative urine pregnancy test before treatment.
4.1.2
Exclusion criteria
1. Subjects presenting with known/previous allergy or hypersensitivity to hyaluronic acid 
(HA) filler, lidocaine or amide type local.
2. Subjects presenting with known/previous allergy or hypersensitivity to streptococcal 
proteins.
3. Subject with bleeding disorders or subjects who are taking thrombolytics or anticoagulants.
4. Subject who is using substances that affect platelet function e.g., aspirin or other non-
steroidal anti-inflammatory drugs (NSAIDs). Cyclooxygenase-2 (COX-2) inhibitors are 
allowed.
5. Subjects using immunosuppressants.
6. Subjects with a previous implant other than HA in or near the intended treatment site.
7. History of other facial treatment/procedure in the previous 6 months HA in or near the 
intended treatment site that, in the Treating Investigator’s opinion, would interfere with the 
study injections and/or study assessments or exposes the subject to undue risk by study 
participation, e.g., Botulinum toxin injections or another HA filler.
8. Subject with a prior surgical procedure in the treatment area which, in the opinion of the 
Treating Investigator could interfere with the study.
9. Presence of any disease or lesions near or on the area to be treated, e.g.:
•
Inflammation, active or chronic infection (e.g., in mouth, dentals, head and neck 
region);
•
Facial psoriasis, eczema, acne, rosacea, perioral dermatitis, herpes simplex or 
herpes zoster;
•
Scars or deformities;
•
Cancer, or precancer such as actinic keratosis or actinic cheilitis.
10. Presence of any condition which, in the opinion of the Treating Investigator, makes the 
subject unable to complete the study per protocol, e.g.:
•
Subject is not likely to avoid other prohibited facial cosmetic treatments 
•
Subject is not likely to complete the study because of other commitments
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 28 of 67
•
Subject is anticipated to be unavailable for visits, incapable of understanding 
the investigational assessments, or has unrealistic expectations of treatment 
result
•
Subject who has a concomitant condition (e.g., acute viral or bacterial infection 
with fever) that might interfere with study treatments or assessments
•
Subject with unattainable expectations.
11. Women who are pregnant or breast feeding, or women of childbearing potential who are 
not practicing adequate contraception or planning to become pregnant during the study 
period.
12. Study center personnel, close relatives of the study center personnel (e.g., parents, children, 
siblings, or spouse), employees, or close relatives of employees at the Sponsor Company.
13. Participation in any other interventional clinical study within 30 days before treatment.
Medical history
History of relevant surgical events and medical conditions should be documented (including any 
prior dermatological procedures or implants) in the eCRF using medical terminology.
Previous and concomitant therapies
4.3.1
Definition
Prior therapies are defined as therapies that have been used within 30 days preceding the Screening 
visit or within the timelines specified in the Inclusion/Exclusion criteria, and then stopped prior to 
the Screening visit.
Concomitant therapies are defined as follows:

any existing therapies ongoing at the time of the Screening visit,

any changes to existing therapies (such as changes in dose or formulation) during the study, 
or

any new therapies received by the subject since the Screening visit.
4.3.2
Categories
The following two categories are to be considered for prior and concomitant therapies:

Drugs/therapies including but not limited to prescription, over-the-counter (OTC), birth 
control pills/patches/hormonal devices, vitamins, herbal medicines/supplements, and 
homeopathic preparations.

Medical and surgical procedures including, but not limited to plastic surgery (surgery to 
either the upper or lower lip, facelift, rhinoplasty, facial liposuction etc.), facial tissue 
augmentation therapy  or cosmetic procedures (e.g. lifting threads, tissue augmentation 
therapy, contouring or revitalization with permanent or non-permanent implants, silicone, 
fat, fillers, Botulinum toxin injections, deoxycholic acid injections, mesotherapy, laser, 
photo modulation, intense pulsed light (IPL), radio frequency, ultrasound, cryotherapy, 
dermabrasion, needling, chemical peeling, or other ablative/non-ablative procedures).
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 29 of 67
4.3.3
Authorized concomitant therapies
Unless listed in prohibited concomitant therapies (section 4.3.4), all therapies are authorized.
4.3.4
Prohibited concomitant therapies
The following therapies are prohibited during the study because they may interfere with the 
effectiveness and/or safety assessment of the study treatment.

Anticoagulants or inhibitors of platelet aggregation (e.g., aspirin, NSAIDs), Omega-3 or 
Vitamin E should not be used within 2 weeks before any treatment to avoid increased 
bruising or bleeding at injection sites. Concomitant treatment with Omega-3 and Vitamin E 
is acceptable only as part of a standard multivitamin formulation and COX-2 inhibitors are 
allowed.

The study product contains lidocaine, but additional local anesthesia may be used. Lidocaine
should however be used with caution in subjects receiving other local anesthetics or agents 
structurally related to amide-type anesthetics, e.g., certain antiarrhythmics, as the systemic
toxic effects can be additive.

Concomitant treatment with chemotherapy, immunosuppressive agents, immunomodulatory 
therapy (e.g., monoclonal antibodies, antiviral treatment for HIV or Hepatitis) is prohibited.

Concomitant treatment with systemic corticosteroids or topical corticosteroids is prohibited 
(inhaled corticoids are allowed). Corticosteroids should be used with caution and should be 
adjudged as necessary by the Investigator.

Planned aesthetic facial plastic surgery (e.g. surgery to the midface, facelift, rhinoplasty, 
facial liposuction etc.), facial tissue augmentation therapy or cosmetic procedures (e.g. lifting 
threads, tissue augmentation therapy, contouring or revitalization with permanent or non-
permanent implants, silicone, fat, fillers, Botulinum toxin injections, deoxycholic acid 
injections, mesotherapy, laser, photo modulation, IPL, radio frequency, ultrasound, 
cryotherapy, dermabrasion, needling, chemical peeling, or other ablative/non-ablative 
procedures) are prohibited.

Planned surgery including aesthetic facial surgical therapy, liposuction, sinus surgery or 
dental root surgery, piercing or tattoo in the area to be treated are prohibited.

Participation in any other clinical study is prohibited.
If a prohibited therapy becomes a necessary treatment for the safety or best interest of the subject, 
the Medical Monitor should be notified, time permitting, to discuss possible alternatives prior to 
administration of a prohibited therapy.
If a subject receives prohibited therapy during the clinical study, the Sponsor should be notified to 
discuss the pertinence and the modalities for the subject to continue in the clinical study.
4.3.5
Documentation and recording instructions
Prior and concomitant therapies are to be recorded on the appropriate form in the eCRF.
Concomitant therapies are to be recorded, reviewed, and updated at each visit.
Any new concomitant therapy or modification of an existing therapy may be linked to an AE. A 
corresponding AE form must be completed to account for the change in therapy, except in some 
cases such as therapy used for prophylaxis or dose modification for a chronic condition.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 30 of 67
Subject identification number
Prior to any study procedures being conducted, the subject must sign the informed consent form 
(ICF). Each subject who has signed the ICF will be assigned a subject number that will be allocated 
in ascending order within each center. A screen failure is a subject who signed the informed consent 
but never enrolled (i.e., was randomized and/or received treatment) in the study. For screen failures, 
the subject source documents should indicate which assessments have been made and the reason 
why the subject was determined to be a screen failure. A screen failure should not be re-entered in 
the study. A subject is considered enrolled when they have signed the ICF and are randomized and/or
treated.
For the duration of the clinical study, each subject will be identified using the subject number for all 
documentation and discussion. A subject identification log is required to be kept in the Investigator 
file. 
5. STUDY INTERVENTION
Description of the investigational device
The term “investigational device” refers to Restylane Lyft Lidocaine.
5.1.1
Investigational device
Restylane Lyft Lidocaine is a sterile, transparent, biodegradable gel supplied in a glass syringe 
together with a 27G or 29G Thin wall (TW) needle(s). The product is for single use only. Restylane 
Lyft Lidocaine is a unique form of non-animal, stabilized hyaluronic acid (NASHA™). Hyaluronic 
acid is a natural polysaccharide which occurs as an important structural element in the skin and in 
subcutaneous and connective tissues as well as in the synovial tissue and fluid. Hyaluronic acid 
belongs to a group of very few substances which are identical in all living organisms.
Restylane Lyft Lidocaine co-packed with two sterilized needles 27G x ½" will be supplied to the 
study centers.
Composition
Hyaluronic acid, stabilized
20 mg/mL
Lidocaine hydrochloride
3 mg/mL
Phosphate buffered saline
q.s.
5.1.2
Reference product
Not applicable. The reference in this study is a No Treatment control.
Additional products and materials
The sponsor will provide pregnancy tests (urinary human chorionic gonadotropin [U-HCG]).
Packaging and labelling
Restylane Lyft Lidocaine is supplied in a blister packed, prefilled plastic syringe. The content of the 
syringe is sterilized using moist heat. For the purpose of this study, commercial products will be 
used. Restylane Lyft Lidocaine should be used according to approved labeling, as per Treating 
Investigator preference. The products are for single use only. In addition to the standard labelling of 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 31 of 67
the device, a study-specific label will be attached, containing study specific information in 
accordance with Canada labeling requirements for commercially available medical devices used in 
clinical trials. Detailed product information is provided in the IFUs (co-packed with product).
Instructions for use and administration
5.4.1
Treatment procedure
The investigational product is reserved for use by Treating Investigators who are experienced with 
deep dermal and subcutaneous injections in the facial area. Treating Investigators should be aware 
of important neurovascular and anatomical structures near injection sites, which include the facial 
artery and vein, mental nerve and artery, parotid gland, superficial temporal artery and vein, and 
marginal mandibular nerve. The treatment procedures for Restylane Lyft Lidocaine should follow 
the approved IFU in Canada (co-packed with product). Before treatment the subject will be informed 
about the expected post-treatment events that should be recorded in the Subject Diary and potential 
risks involved with the treatment and when to contact the Treating Investigator in case of emerging 
symptoms.
Detailed information regarding the injection procedure, pre- and post-treatment care, and Subjects’ 
instructions are provided in the IFU.
5.4.1
Pre-Treatment procedure
Before the treatment, the Subject’s suitability for the treatment and the need for pain relief should 
be assessed. Normally, no anesthesia is necessary when shaping the contours of the face and 
correcting folds. 
The Subject should be informed about the indications, expected result, contraindications, 
precautions, warnings and potential adverse events.
The treatment site should be cleaned with a suitable antiseptic solution.
5.4.2
Treatment regimen (dose and interval) 
Subjects in the Treatment group will receive one Restylane Lyft Lidocaine treatment at baseline 
(initial treatment) and one optional touch-up treatment 1 month after initial treatment, if deemed 
necessary by Treating Investigator and subject to obtain optimal aesthetic improvement. Subjects in 
the No Treatment control group will be offered treatment at the 12 months follow-up visit. 
Subjects will be treated to obtain optimal jawline correction, which is defined as at least 1 GJS grade 
improvement from baseline and best correction that can be achieved as agreed upon by the Treating 
Investigator and the Subject.
Restylane Lyft Lidocaine will be administered by needle (27G x ½" or 29G (TW) x ½") or cannula
(23-25G) injections. The Treatment procedures for Restylane Lyft Lidocaine should follow the 
approved IFU in Canada (co-packed with product).
The size and the length of the cannula will affect the force needed to extrude the gel. If a thinner 
cannula is used the resistance during injection may be too high resulting in an increased risk for 
leakage or separation of the cannula and syringe. The same considerations are applicable for needles.
The injection technique with regard to the depth of injection and the administered quantity may vary.
Injection technique is at the Treating Investigator´s discretion in the deep dermal and subcutaneous 
tissue. Deeper injections into the subcutaneous fatty tissue or supraperiosteal layer are appropriate 
for areas with adequate soft tissue support and soft tissue cover such as jawline.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 33 of 67
accountability records, i.e., documentation of the physical location of all study products, deliveries, 
and return of study products between the Sponsor and the PI, and documentation of administration 
of product to the subject. A shipping record shall be kept of all study products received from the 
Sponsor; including the product name, date received, lot number, expiration date and amount 
received. In addition, dispensing logs shall be maintained including the product name, batch number, 
expiry date, dispense date, the number of syringes used, the subject receiving study product, and 
number of syringes left in stock at the site. When the study is completed, all unused or expired study 
product at each study center shall be returned to the Sponsor for destruction or destroyed locally at 
the center, if documented as agreed with the Sponsor. Any malfunctioning study products shall be 
reported as described in Section 8.3.3. Products deliberately or accidentally destroyed during 
shipment or at a study center shall be accounted for and documented. Used syringes, needles and 
cannula and any opened unused material must be discarded immediately after the treatment session 
and must not be reused due to risk for contamination of the unused material and the associated risks 
including infections according to standard procedures at the center. Disposal of hazardous material 
i.e., syringes and needles, must conform to applicable laws and regulations. All study product(s) 
sent to the PI will be accounted for and no unauthorized use is permitted.
5.5.2
Storage of study product
The syringes should be stored in their original packaging at a temperature up to 25°C (77°F), 
protected from sunlight and freezing. Opened packages or partially used devices should not be 
reused. Detailed product information is provided in the IFU.
5.5.3
Dispensing and return
The treatment will be administered by the Treating Investigator at the study center and be 
documented in the accountability records.
When the study is completed, all unused or expired study products at each study center should
be returned to the Sponsor representative for destruction, or to be destroyed locally at the study 
center if documented as agreed with Sponsor.
5.5.4
Treatment compliance
Not applicable; the treatment will be administered by the injector at the investigational center.
Randomization
Before starting the study, a computer-generated randomization list will be prepared using an 
Interactive Response System under the supervision of a designated statistician from the Sponsor. 
Approximately 140 subjects will be randomized in a 3:1 ratio to treatment with Restylane Lyft 
Lidocaine or no treatment. Randomization numbers will be allocated in ascending sequential order 
to each subject. 
Blinding
The Treating Investigator will not be blinded to study treatments.
A Blinded Evaluator, to whom randomization and treatment are concealed, will conduct the blinded 
assessments. To the extent possible, the same Blinded Evaluator should assess an individual subject 
throughout the study.
The Blinded Evaluator is not allowed to be present during the injections or to discuss treatments 
with the Treating Investigator or subjects. All documents with information regarding study products 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 34 of 67
and randomization assignment should be kept in a separate file not available to the Blinded 
Evaluator.
Safety assessments will be performed by non-blinded Investigator as treatment-related AEs are 
expected to occur during a few days after treatment, thereby revealing which subjects have received 
the study product.
5.7.1
Verification of blinding
Not applicable.
5.7.2
Emergency unblinding
Not applicable as the Treating Investigator is not blinded to treatment.
Post-trial provisions 
In time, the implant will be degraded in the body and additional treatments will be necessary to 
maintain the aesthetic result. 
After the final study visit, the Sponsor will not supply any more treatments to the subjects in the 
Treatment group, even if the result does not persist.
6. EFFECTIVENESS ASSESSMENTS
Effectiveness Assessment Methods
The methods for collecting effectiveness data are described in the following sections. To minimize 
inter-observer variability, every effort should be made to ensure that preferably the same individual 
who made the initial baseline determinations completes all corresponding follow-up evaluations.
For study evaluation purpose, the effectiveness assessments described below will be performed. 
Assessments should be performed according to the time points indicated in Table 1 and Table 2: 
Schedule of events and recorded in the eCRF.
Photography
Photographs will be taken prior to treatments with study product and at every follow-up visit in order 
to document treatment effect. Photographs may also be taken to document AEs at the Treating 
Investigator’s discretion. Baseline photographs will be used as a reference in the GAIS assessment. 
Study site personnel will be thoroughly trained in the photographic equipment and techniques before 
study start.
Camera equipment will be provided by the Sponsor, or their designee and standardized photographs 
should be achieved. Further details regarding photography procedure will be specified in a separate 
user guide.
Galderma Jawline Scale (GJS)
The GJS is a validated 5-point scale for assessment of jawline (see Appendix 1). Each score in the 
GJS is exemplified by photographic images of the scale. The Blinded Evaluator and Treating 
Investigator will perform live assessment of the subject’s left and right jawline separately. 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 35 of 67
The Blinded Evaluator will perform GJS assessments as specified in the Schedule of Assessments 
(Table 1 and Table 2).
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 36 of 67
Global Aesthetic Improvement Scale (GAIS)
The 7-graded GAIS will be used to live assess the aesthetic improvement of the jawline, i.e.,
improvement from baseline appearance before the first treatment by the Treating Investigator and 
the Subject, independently of each other. The GAIS will be assessed by the Treating Investigator 
and the Subject as specified in the Schedule of Assessments (Table 1 and Table 2).
The baseline archival photographs (obtained prior to injection at baseline) will be used as a 
comparison for the GAIS evaluation. The Treating Investigator will assess the GAIS based on the 
definition in Table 3.
Table 3
Investigator Global Aesthetic Improvement Scale (GAIS)
Rating (Treating 
Investigator and 
Subject
Definition (only for Treating Investigator)
Very Much Improved
Optimal aesthetic result for the implant for this subject.
Much Improved
Marked improvement in appearance from the initial condition, but
not completely optimal for this subject.
Improved
The appearance is improved from the initial condition.
No Change
The appearance is essentially the same as baseline.
Worse
The appearance is worse than the initial condition.
Much Worse
Marked worsening in appearance from the initial condition.
Very Much Worse
Obvious worsening in appearance from the initial condition.
The Subject will respond to the question: “How would you describe the aesthetic improvement of 
the treatment area today compared to the photograph taken before treatment?” by using the 
categorical scale below. 
Rating
Very Much Improved
Much Improved
Improved
No Change
Worse
Much Worse
Very Much Worse
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 37 of 67
7. SAFETY ASSESSMENTS
General information
The safety assessment described below are included specifically for the study. For clinical practice 
the IFU supplied with the product will include information needed to handle the product safely. This 
includes information that the product has not been tested in pregnant or breastfeeding women or in 
children.
Subject Diary Data
The Subject from the Treatment group shall evaluate local tolerability in a 28 days diary, starting on 
the day of each treatment. The presence and maximum intensity of pre-defined, expected post-
treatment events, i.e., bruising, redness, pain, tenderness, lumps/bumps, itching and swelling shall 
be assessed for the treated area. 
The Investigator or study staff should review the diary for completion and clarify any events as 
needed. For events that are ongoing at the time of diary completion, the Investigator should follow 
them and record resolution in the subject’s study file and eCRF. Diary data will be analyzed and 
displayed separately from AE data.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 38 of 67
Laboratory assessment
For all women of childbearing potential, including those currently using contraception, a urine 
pregnancy test is required prior to receiving any study treatment (Day 1, optional touch-up or 
optional treatment). The test result must be negative for the subject to receive any treatment 
with study product. The test result will be documented in the subject’s file and eCRF.
Adverse events
The definition of an Adverse Event (Medical Devices Regulation (MDR) article 2(57)): An AE is 
any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other personsI, in the context of a 
clinical investigation, whether or not related to the Investigational device. 
This definition includes:
a) events related to the investigational product or the reference product
b) events related to the procedures involved
c) events that are anticipated as well as unanticipated
Adverse Event reporting on each subject shall start once a subject is enrolled (i.e., randomized and/or 
treated) in the study. All other events that occur after the subject signs the ICF but before enrollment 
will be recorded in the subject’s medical history. The reporting shall continue during each follow-
up visit (including telephone contacts and extra visits between planned visits) until the last scheduled 
visit in the study.
All AEs, non-serious as well as serious, are to be reported as an AE in the eCRF. A request for 
additional information from the Sponsor/ Contract Research Organization (CRO) Medical Expert(s) 
for non-serious AEs, should be collected and answered using the Adverse Event Clarification Form.
7.4.1
Anticipated adverse events
Injection related AEs such as bruising, erythema, itching, swelling, pain and tenderness are 
anticipated. Information regarding anticipated AEs for Restylane Lyft Lidocaine is included in the 
IFU (co-packed with product).
7.4.2
Assessment of severity
Intensity will be recorded for each reported AE. The following definitions of intensity are to be used:
Mild:
Awareness of symptoms or signs, but easily tolerated (acceptable)
Moderate:
Enough discomfort to interfere with usual activity (disturbing) 
Severe:
Incapacity to work or to do usual activity (unacceptable)
If the intensity changes within one day, the maximum intensity of the AE during that day shall be 
recorded.
                                                
I For users or other persons, this definition is restricted to events related to the investigational product.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 39 of 67
7.4.3
Assessment of causality 
Each AE shall be assessed by the Investigator for causal relationship with the study product and its 
use (the injection procedure) and for seriousness (Yes or No) of the event. 
A two-point scale (Yes or No response) shall be used for the causality assessments. The Investigators 
shall be asked to indicate a response to each of the following questions in the eCRF:

“Do you consider that there is a reasonable possibility that the event may have been caused 
by the study product?”, and 

“Do you consider that there is a reasonable possibility that the event may have been caused 
by the study product injection procedure?”
If any of these questions is answered Yes, the AE is considered related. 
Each AE will also be assessed for causal relationship and seriousness by the Sponsor, in order to 
fulfil regulatory requirements. 
In addition, each Serious Adverse Event (SAE) will be classified by both the Investigator and 
Sponsor separately, according to four different levels of causality:
1. Not related - Relationship to the device, comparator or procedures can be excluded when:

the event has no temporal relationship with the use of the investigational device, or the 
procedures related to investigational device;

the serious adverse 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 adverse event;

the event involves a body-site or an organ that cannot be affected by the device or 
procedure;

the serious adverse 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;
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 adverse event.
2. Possible - The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, 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 where relatedness cannot be assessed, or no 
information has been obtained should also be classified as possible.
3. Probable - The relationship with the use of the investigational device or comparator, or the 
relationship with procedures, seems relevant and/or the event cannot be reasonably explained 
by another cause.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 40 of 67
4. Causal relationship - the serious adverse event is associated with the investigational device, 
comparator 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
o
the investigational device or procedures are applied to;
o
the investigational device or procedures have an effect on;

the serious adverse 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 adverse 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 adverse event.
7.4.4
Action taken
The action taken (none, medication treatment, non-pharmacological treatment, or other 
procedures/tests, subject withdrawn) for an AE should be recorded in the eCRF.
The study related medical care provided to the subjects during the study is the responsibility of an 
appropriately qualified medical doctor (i.e. the Principal Investigator [PI]) or, where appropriate any 
other person entitled by national law to provide the relevant patient care.
7.4.5
Follow-up of adverse events
7.4.5.1
Follow-up of unresolved events ongoing at termination of the study
All serious as well as non-serious AEs with a causal relationship to the study product or treatment 
procedure and ongoing at study end / or ongoing when subject early terminated study participation 
/ or ongoing if study is temporarily halted, shall be followed up after the subject's participation in 
the study is over. Such events shall be followed-up until resolved, assessed as chronic or stable, or 
subject is lost to follow up. Final outcome after the end of the study shall be reported on the AE 
Follow-up form. Other AEs will be monitored until the last visit if they have not resolved or reached 
a stable condition.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 41 of 67
7.4.5.2
Follow-up of events occurring after subject termination of the study
All Adverse Events with a causal relationship to the study products or treatment procedure that the 
Investigator becomes aware of, serious as well as non-serious, with onset after the study termination 
(subject’s last study visit) shall be reported to the Sponsor by email to safety.q-med@galderma.com.
The Investigator shall follow the subject until the event is resolved. 
7.4.6
Documentation and recording instructions
Investigators, or other study site personnel, shall record all AEs in the eCRF, including:
a) Event term (recorded in standard medical terminology and avoiding abbreviations)
b) Affected area
c) Start date (first day with symptoms)
d) Stop date (last day with symptoms)
e) Intensity (mild, moderate, or severe according to definition in section 7.4.2)
f)
Seriousness (serious or not serious, according to definition in section 7.5)
g) Relationship to study product or study product injection procedure (According to definition 
in Section 7.4.3)
h) Action taken (none, medication treatment, non-pharmacological treatment, or other 
procedures/tests, subject withdrawn)
i)
Outcome of the AE (ongoing, resolved, resolved with sequelae, death) at the end of the study. 
The AE form/module in the eCRF must be signed and dated by the Investigator.
Serious Adverse Events
The Definition of a Serious Adverse Event (MDR article 2(58)):
A Serious Adverse Event (SAE) is any AE that:
a) led to death,
b) led to serious deterioration in the health of the subject, that either resulted in
1. a life-threateningII illness or injury, or
2. a permanent impairment of a body structure or body function, or
3. hospitalization or prolonged hospitalizationIII, or
4. medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
5. chronic disease
c) led to fetal distress, fetal death, or a congenital physical or mental impairment or birth defect
                                                
II The term “life-threatening” in the definition of “serious” refers to an event in which the patient was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more 
severe. (Source: ICH-E2A clinical safety data management: definitions and standards for expedited reporting).
III Planned hospitalization for a pre-existing condition, or a procedure required by the CSP, without serious deterioration 
in health, is not considered a SAE. (Source: ISO14155:2011).
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 42 of 67
In cases of doubt, whether an AE fulfils a serious criterion or not, there should be a predisposition 
to report as a SAE rather than not report as such.
When an AE is related to a device deficiency (refer to section 7.7.3), including technical device 
malfunction, the AE shall be recorded on the AE form/module in the eCRF and the technical 
complaint shall be reported separately on the clinical study complaint form.
Device deficiencies
A device deficiency is defined as an inadequacy of a medical device with respect to its identity, 
quality, durability, reliability, safetyIV, or performance.
Note: Device deficiencies include malfunctions, user errors or inadequate information supplied by 
the manufacturer.
Safety report procedures and timelines
Safety evaluations for this study include an interview of the subjects at each visit to obtain 
information about any medical occurrence that meets the definition of an AE. Each subject should 
be questioned about AEs at each study visit following the baseline visit. An event that occurs after 
the subject signs the ICF but before enrollment (i.e., randomized and/or treated) will be recorded in 
the subject’s medical history. The question about AEs should be asked: “Since your last clinical visit 
have you had any health problems?”  Information on AEs can also be obtained from signs and 
symptoms detected during each examination by the Investigator or designee, which should include 
visual inspection of the treatment area or from a laboratory test, subject diaries, or spontaneous 
reports from the subjects or their relatives.
AEs must be documented in the source document and eCRF without regard for cause or relation to 
investigational product. If in the process of the interview, additional information regarding medical 
history or pre-planned medical or surgical procedures is revealed, it must be documented in the 
source document(s) and eCRF.  
It is the responsibility of the Investigator to determine severity of the AE and relatedness of the event 
to the study product.  
7.7.1
Reporting of Serious Adverse Events
The Investigator shall report any SAE to the Sponsor immediately but not later than 24 hours of 
awareness of the event. This initial report shall be submitted via the eCRF.
In case of difficulty to obtain all the required information within 24 hours, an initial report can be 
submitted, with the following information as a minimum, irrespective of whether some of it is 
regarded as preliminary:

Subject identification (age, gender, initials, subject number)

Adverse event description

Date when AE occurred

Name of PI

Name of study product
                                                
IV Inadequacy of device safety refers to properties of the device which could have or have led to an AE.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 45 of 67
8. DESCRIPTION OF STUDY VISITS
Visit 1: Screening (Day-21-D1)
The following activities and screening assessments will be performed within 21 days prior to 
baseline/Day 1 visit:

Obtain Informed Consent.

Obtain demographic data: Date of birth, gender, ethnicity, race, and FST. For determination
of the FST, see Table 4.

Record the subject’s medical history (including any prior dermatological procedures or 
implants) and prior or concomitant therapies.

For all females of childbearing potential, perform urine pregnancy test (UPT) prior to 
treatment. Test result must be negative for the subject to be eligible for treatment.

Assess GJS – Treating Investigator and Blinded Evaluator.

Assess eligibility (inclusion and exclusion criteria).

Schedule the baseline/Day 1 (initial treatment) visit or proceed to Day 1 activities if subject 
meets all eligibility criteria.
Table 4: Fitzpatrick Skin Type (FST) 
Skin type
Skin color
Skin characteristics
I
White; very fair; red or blond hair; blue eyes; 
freckles
Always burns, never tans
II
White; fair; red or blond hair; blue, hazel or green 
eyes
Usually burns, tans with difficulty
III
Cream white; fair with any eye or hair color; very 
common
Sometimes mild burn, gradually tans
IV
Brown; typical Mediterranean Caucasian skin
Rarely burns, tans with ease
V
Dark brown; Middle Eastern skin types
Very rarely burns, tans very easily
VI
Black
Never burns, tans very easily
FST is a skin classification system that categorizes different skin colors, and their reactions to ultraviolet light5.
Visit 2: Baseline (Day 1, Initial Treatment)
The screening visit and baseline visit (Day 1) may be performed on the same day if a subject is 
deemed eligible by the Treating Investigator.
If screening visit and baseline/Day 1 visit are not performed on the same day, the following 
procedures should be repeated at the baseline/Day 1 visit:

Review for changes in medical history and concomitant therapies.

Re-confirm eligibility criteria.

Perform UPT for all females of childbearing potential Test result must be negative for the 
subject to be eligible for study treatment.

Assess GJS – Treating Investigator and Blinded Evaluator (see Section 6.3).
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 46 of 67
Once the subject is deemed eligible for study participation by the Treating Investigator, the following 
procedures should be completed:

Record the subject’s self-reported height and weight.

Obtain pre-treatment photographs of the jawline.

Randomize the subject to treatment or to no treatment. 

Obtain pre-treatment/baseline responses to the 
with Lower Face 
and Jawline.
For subjects randomized to no treatment:

Schedule Visit 3, 1 month (+7 days) after baseline visit), 
For subjects randomized to treatment:

Subjects will be injected with the study product.

Record all concomitant medications/procedures used prior, during, or after the injection 
session.

Record the number of syringes used and the volume of study product injected per treatment 
area during the injection session. Record the injection details (i.e., injection method and 
depth of injection).

Evaluate for device deficiencies. If deficiencies are noted, complete form as specified in 
section 7.7.3.

Evaluate post-injection AEs by Treating Investigator.

Dispense Subject Diary and instruct subject on Diary completion. Remind the subject to 
bring the diary to next on-site study visit.

Schedule the 72 hours (±24 hours) follow-up phone call (Visit 2a).

Schedule Visit 3, 1 month (+7 days) after the baseline visit (Visit 2).
8.2.1
Visit 2a: Follow up 72-hour (±24 hours) telephone call after initial treatment
Visit conducted for subjects randomized to treatment only.

Interview subject regarding any concomitant therapies.

Interview subject regarding any AEs that have occurred since receiving treatment. If AEs are 
reported, notify the Investigator immediately and determine whether subject should return to 
the site for an unscheduled visit. The Investigator should assess all reported AEs in a timely 
manner.

Interview subject regarding the return to social engagements, where the Subject will be asked 
on when (in hours after treatment) the subject feels comfortable returning to social 
engagements (public/social appearances) exemplified as returning to business office or other 
public workplace, having dinner in a public restaurant, attending a social event/gathering 
such as dinner party, etc.

Interview subject regarding the Diary completion and reported events since receiving 
treatment. Remind subject to complete the Diary daily and bring it to the next on-site visit.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 47 of 67

Remind subject of the next scheduled on-site visit.
Visit 3: Follow up visit 1 month (+ 7 days) after initial treatment / 
Optional touch-up or after baseline for the No Treatment group

Interview subject regarding any concomitant therapies.

Interview subject and evaluate any AEs that have occurred since the last visit.

Obtain photographs (if treatment is given, ensure photos are taken prior to injection)
For subjects randomized to no treatment:

Schedule Visit 4, 3 months (±7 days) after baseline visit).
For subjects randomized to treatment

Collect and review Subject Diary:
o
Review diary entries for completeness and legibility.
o
If the subject handwrites entries on the diary pages, review these entries with 
the subject and clarify as needed. Record all clarifications on the subject’s 
source documents and record the Diary data into the eCRF.

Assess whether optimal aesthetic result has been achieved and determine whether optional 
touch-up is appropriate.

Subject must meet eligibility criteria for touch-up to be provided.  

Touch-up should not be provided if the subject has a disease or condition
described in the exclusion criteria, or an ongoing treatment-related AE that in the 
opinion of the Treating Investigator would be worsened by a touch-up.

Schedule Visit 4, 3 months (±7 days) after last treatment for subjects not receiving touch-
up.
If touch-up is to be performed:

Prior to any treatment, perform UPT for all females of childbearing potential. The test result 
must be negative for a subject to receive the touch-up treatment.

Prior to any treatment, assess GJS – Treating Investigator.

Subjects will be injected with the study product.

Record all concomitant medications/procedures used prior, during or after the injection 
session.

Record the number of syringes used and the volume of study product injected per treatment 
area during the injection session. Record the injection details (i.e. injection method and 
depth of injection).

Evaluate for device deficiencies. If deficiencies are noted, complete form as specified in 
Section 7.7.3.

Evaluate post-injection AEs by Treating Investigator
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 48 of 67

Dispense a new Subject Diary and instruct subject on Diary completion. Remind the subject 
to bring the diary to next on-site study visit.

Schedule the 72 hours (± 24 hours) follow-up phone call (Visit 3a) and Visit 3b, 1 month (+ 
7 days) after optional touch-up.
8.3.1
Visit 3a: Follow up 72-hour (±24 hours) telephone call after optional touch-up 
performed
This visit should only be conducted for subjects who received a touch-up treatment at Visit 3.

Interview subject regarding any concomitant therapies.

Interview subject regarding any AEs that have occurred since receiving treatment. If AEs are 
reported, notify the Investigator immediately and determine whether subject should return to 
the site for an unscheduled visit. The Investigator should assess all reported AEs in a timely 
manner.

Interview subject regarding the return to social engagements, where the Subject will be asked 
on when (in hours after treatment) the subject feels comfortable returning to social 
engagements (public/social appearances) exemplified as returning to business office or other 
public workplace, having dinner in a public restaurant, attending a social event/gathering 
such as dinner party, etc.

Interview subject regarding Subject Diary completion and reported events since receiving 
treatment. Remind subject to complete the Subject Diary daily and bring it to the next on-
site visit.

Remind subject of the next scheduled on-site visit.
8.3.2
Visit 3b: Follow up visit 1 month (+ 7 days) after optional touch-up performed
This visit should only be conducted for subjects who received a touch-up treatment at Visit 3.

Interview subject regarding any concomitant therapies.

Interview subject and evaluate any AEs that have occurred since the last visit.

Collect and review Subject Diary:
o
Review diary entries for completeness and legibility.
o
If the subject handwrites entries on the diary pages, review these entries with the 
subject and clarify as needed. Record all clarifications on the subject’s source 
documents and record the Diary data into the eCRF.

Obtain photographs.

Schedule Visit 4, 3 months (±7 days) after last treatment
Visit 4 to 6: Follow-up visits 3, 6 and 9 months (± 14 days) after last 
treatment or after baseline for the No Treatment group

Interview subject regarding any concomitant therapies.

Interview subject and evaluate any AEs that have occurred since the last visit.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 49 of 67

Obtain photographs.

Assessments to be performed:
o
GJS – Blinded Evaluator
o
GAIS – Treating Investigator and Subject
 

Schedule Visit 5, 6 and 7, for 6, 9 and 12 months ± 7 days after the last treatment (Visit 2 
or Visit 3) if any touch-up for the Treatment group or after baseline for the No Treatment 
group.
Visit 7: Follow-up visit 12 months (± 14 days) after last treatment / after 
baseline for the No Treatment group

Interview the subject regarding concomitant therapies.

Interview subject and evaluate any AEs that have occurred since the last visit.

Record subject’s weight.

Obtain photographs (if treatment is given, ensure photos are taken prior to injection)

Assessments to be performed, prior to optional treatment:
o
GJS – Blinded Evaluator
o
GAIS – Treating Investigator and Subject
For subjects in the No Treatment (control) group receiving optional treatment:

Subject must meet eligibility criteria for treatment to be provided.  Treatment should not be 
provided if the subject has a disease or condition described in the exclusion criteria or
an ongoing treatment-related AE that in the opinion of the Treating Investigator would be 
worsened by a treatment.
If treatment is to be performed:

Prior to any treatment, assess GJS – Treating Investigator.

Prior to any treatment, perform UPT for all females of childbearing potential. The test result 
must be negative for a subject to receive the optional treatment.

Subjects will be injected with the study product.

Record all concomitant medications/procedures used prior, during or after the injection 
session.

Record the number of syringes used and the volume of study product injected per treatment 
area during the injection session. Record the injection details (i.e., injection method and 
depth of injection).
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
C
C
I
C
C
C
C
I

CONFIDENTIAL
Page 50 of 67

Evaluate for device deficiencies. If deficiencies are noted, complete form as specified in 
Section 7.7.3.

Evaluate post-injection AEs by Treating Investigator

Schedule the 14 days (± 7 days) follow-up visit (Visit 7a) after optional treatment.
For subjects in the Treatment group and No Treatment (control) group not receiving any optional 
treatment:

Remind subjects to contact the study center if any new AE occurs after study exit. Subjects 
will be asked to return to the study center to be evaluated and receive treatment, if applicable.

Complete the End of Study form in the eCRF
8.5.1
Visit 7a: Follow up visit 14 days (± 7 days) after optional treatment
This visit should only be conducted for subjects who received optional treatment at Visit 7.

Interview subject regarding any concomitant therapies.

Interview subject and evaluate any AEs that have occurred since the last visit.

Assessments to be performed:
o
GAIS – Treating Investigator and Subject

Remind subjects to contact the study center if any new AE occurs after study exit. Subjects 
will be asked to return to the study center to be evaluated and receive treatment, if applicable.

Complete Study Exit form in the eCRF.
9. STATISTICAL DESIGN AND ANALYSIS
General
A Statistical Analysis Plan (SAP) with a description of all statistical analyses will be developed.
All study data will be listed in subject data listings. All statistical analyses, including summary tables 
and data listings, will be performed using SAS. Confidence intervals will be two-sided and 
constructed at a confidence level of 95%.
All endpoints will be summarized descriptively. Continuous endpoints will be summarized using
mean, median, standard deviation (SD), minimum and maximum values, for the observed value as
well as the change from baseline. Categorical endpoints will be presented in frequency tables with
number and percentage of observations for each level.
Analysis populations
The following populations will be defined:
Safety population:
Includes all subjects who were treated with Restylane Lyft Lidocaine. Subjects are analyzed based 
on the as treated principle (i.e., according to the treatment actually received).
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 51 of 67
Intention-to-treat (ITT) population:
Includes all subjects who were randomized based on the as randomized principle (i.e. according to 
the treatment they were randomized to).
Per protocol (PP) population:
Includes all subjects in the ITT who complete the visit 4 after baseline without any deviations 
considered to have substantial impact on the primary effectiveness outcome.
The ITT is the primary population for all effectiveness analyses. The primary effectiveness analysis
will be repeated using the PP analysis set if there is at least a 10% difference in the number of
subjects between the PP and ITT sets. Safety analysis is performed based on the safety population. 
The disposition of subjects will be presented in tables and/or figures as appropriate.
Demographics, baseline assessments, and subject characteristics
Demographic endpoints, baseline assessments, and subject characteristics will be presented by 
treatment group, based on the ITT analysis set using descriptive statistics, as appropriate.
Effectiveness analysis
Continuous endpoints will be summarized using descriptive statistics, e.g., mean, median, SD,
minimum and maximum values. Categorical endpoints will be presented in frequency tables with 
number and percentage of observations for each level.
Responder rate regarding GJS and GAIS will be presented together with a 95% confidence interval 
(based on the binomial distribution). The difference in responder rate regarding GJS and GAIS will 
be calculated between the two groups presented together with a 95% confidence interval.
For the primary effectiveness analysis, a responder will be defined as a subject with at least 1 point 
improvement from baseline based on the GJS. For a significant result, the two-tailed p-value of the 
comparison of responder rates between the treated and untreated subjects at 3 months using the 
Fisher’s exact test needs to be smaller than 0.05.
No adjustment to the level of significance will be performed; p-values obtained for any endpoint 
other than the primary will only be provided for ease of interpretation of the results.
Secondary analyses will include analysis of responders at each visit. Robustness of the results of the 
primary endpoint and adverse events analysis will be investigated across the PP population. All 
formal statistical testing will be performed at a significance level of 5% (2-sided).
Safety analysis
The number and percentage of subjects reporting each pre-defined, expected, post-treatment 
symptom, as collected in the 28-day diary, will be presented in total and by maximum intensity.
Number of days with the event will be presented.
All AEs will be coded according to medical dictionary for regulatory activities (MedDRA) and 
summarized by system organ class (SOC), preferred term (PT) and treatment. AEs related to the 
study device or injection procedure and unrelated AEs will be presented by maximum intensity, 
SOC and PT. For related AEs, the number of days to onset and the duration of the event will be 
summarized by SOC and PT using mean, SD, min, max and median. Action taken for related AEs 
will also be summarized by SOC and PT. Serious AEs will be listed. 
In addition, a summary of all AEs will be provided, which will include (but is not limited to):
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 52 of 67

number of subjects with at least one AE and number of events (in total as well as SAEs)

number of subjects with at least one related AE and number of events (in total as well as
SAEs)

number of subjects with at least one un-related AE and number of events (in total as well as
SAEs)

number of subjects who did not have an AE
Handling of missing data
The number of missing values will be summarized and reported as appropriate. For the ITT analysis 
of the Treating Investigator GJS Responder rate at Month 3 after last treatment for Treatment group
(primary endpoint), missing values will be assumed to be missing due to lack of effect. Therefore, 
the primary method of imputation will use the baseline observation carried forward (BOCF) method.
Impact of missing data on the primary endpoint will be evaluated by performing sensitivity analysis 
based on the observed cases, as well as worst-case and best-case imputation in the ITT set.
All other effectiveness endpoints will be evaluated based on the observed cases in ITT.
Descriptive statistics of all safety data will be performed on observed cases in the Safety population
Interim analysis
No formal interim analysis will be performed. However, analysis of data could take place at a time 
point after the last collection of primary endpoint data. This will not affect the conduct of the study,
and none involved in the study will have access to this data. The SAP will be final and signed before 
this data cut.
Independent data monitoring committee
Not applicable to this study.
Withdrawals and deviations
All withdrawn subjects will be listed individually, including at least subject number, date and reason 
for withdrawal, and last visit performed.
Subjects with CSP deviations will be listed individually, including subject number, and observed 
deviation. Depending on the seriousness of the deviation, the subject may be excluded from the PP 
population, which shall be documented prior to database lock (DBL).
Deviations from the statistical plan will be documented in the Clinical Study Report (CSR). If the
statistical plan needs to be changed before DBL, but after the finalization of the SAP, the SAP will 
be amended.
Sample size
A total sample size of approximately 140 subjects will be included in this study. For the responder 
rate in GJS, a Fisher's exact test using a 5% two-sided significance level will have approximately 
90% power to demonstrate difference between a responder rate of 70% in the Restylane Lyft 
Lidocaine group, and a responder rate of 35% in the no treatment control group when the sample 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 53 of 67
sizes are 105 and 35, respectively. Accounting for 10% dropouts, approximately 140 subjects need 
to be randomized in a 3:1 ratio.
10. ETHICS AND GENERAL CLINICAL STUDY CONDUCT
Ethical considerations
10.1.1 Statement of ethical compliance
The study shall be conducted in compliance with the CTA, the Clinical Study Protocol (CSP), GCP, 
and applicable regional and national regulations. The study shall be conducted in accordance with 
the ethical principles that have their origin in the Declaration of Helsinki (1964, and its amendments 
in force at the initiation of the study).
The study shall follow the international standard for clinical study of medical devices for human 
subjects, ISO 14155:2020.
The study related medical care provided to the subjects during the study is the responsibility of an 
appropriately qualified medical doctor (i.e., the PI) or, where appropriate any other person entitled 
by national law to provide the relevant patient care.
10.1.2 Application to research ethics board and/or regulatory authorities
It is the responsibility of the Principal Investigator (PI) to obtain approval of the CSP/CSP 
amendment(s) from the REB The study shall not begin until the required favorable opinion from the 
REB has been obtained. The PI shall file all correspondence with the REB in the Investigator file 
and copies of REB approvals shall be forwarded to the Sponsor. Any additional requirements 
imposed by the REB or regulatory authorities (RA), shall be followed.
The study does not require application for approval from the RA as it is a post approval phase IV 
study. The collection, access to, processing, and transfer of protected health information or sensitive 
personal data shall be carried out in accordance with applicable rules and regulations.
Subject information and consent
The PI or his/her authorized designee must always use the REB-approved subject information and 
ICF and it must not be changed without prior discussion with the Sponsor and approval from the 
applicable REB. 
It is the responsibility of the PI or his/her authorized designee to give each subject prior to inclusion 
in the study, full and adequate verbal and written information regarding all aspects of the clinical 
study that are relevant to the subject’s decision to participate throughout the study, e.g., explain the 
purpose and procedures of the study, the duration and number of expected participants, possible 
risks involved, and the opinion of the REB. The subject shall be informed that the participation is 
confidential and voluntary and that the subject has the right to withdraw from the study at any time, 
without any consequences to his/her future medical care, treatment, or benefits to which the subject 
is otherwise entitled. The information shall be provided in a language clearly and fully 
understandable to the subject. The subject shall be given sufficient time to read and understand the 
ICF and to consider participation in the study. Before any study-related activities are performed, the 
ICF shall be personally signed and dated by the subject and the PI or his/her authorized designee 
responsible for conducting the informed consent. The consent includes information that data will be 
collected, recorded, processed, and may be transferred to other countries. 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 54 of 67
Photographs collected during the study will be analyzed and stored in a database by the Sponsor and 
its representatives in order to evaluate the effect of the treatment in the study. The subjects will be 
recognizable on the photographs, but their names will not be disclosed.
All signed ICF shall be filed in the Investigator file. The subject shall be provided with a copy of 
the signed and dated ICF and any other written information.
The Investigator shall ensure that important new information is provided to new and existing 
subjects throughout the study.
Personnel training
It is the responsibility of the PI to ensure that all personnel involved in the study are fully informed 
of all relevant aspects of the study, including detailed knowledge of and training in all procedures 
to be followed. All Investigators and other responsible persons shall be listed together with their 
function in the study on the signature and delegation log.
The product is reserved for use by the PI or his/her authorized designee in accordance with local 
legislation, trained in the appropriate aseptic injection techniques and expected to follow the 
recommendations in the study specific IFUs. Additional training for treatment with the study 
products in the midface will be provided by the Sponsor. 
Data management and documentation
Data management based on GCP refers to the activities defined to achieve safe routines to enter 
clinical data information into a database, efficiently and avoiding errors. The data management 
routine includes procedures for 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 data management process will be described in detail in the data management plan 
(DMP).
The database, the data entry screens, and program will be designed in accordance with the CSP and 
the eCRF specification. Data validation will be performed by computerized logical checks and 
manual review. Drugs and events will be coded in accordance with World Health Organization 
(WHO) Drug and MedDRA dictionaries as specified in the DMP. Safety data (SAE and if applicable 
AE of special interest) in the clinical database will be reconciled against the data in the safety 
database.
When all efforts have been made to ensure that the data recorded in the eCRFs and entered in the 
database is as correct and complete as possible, the clinical database will be locked. Study data will 
be transferred to SAS datasets, which thereafter will be write-protected. Statistical analyses will be 
generated in SAS using data from the locked datasets.
10.4.1 Data entry and collection
An electronic data capture application, compliant with regulatory requirements for software 
validation will be used to collect, modify, maintain, archive, retrieve, and transmit study data. An 
eCRF is required and shall be completed electronically for each screened subject (screening visit) 
and included subjects (subsequent visits). The eCRF includes password protection and internal 
quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 55 of 67
or inaccurate. Study data should be entered directly from the source documents, which are to be 
defined at each study center before inclusion of the first subject.
Authorized study center personnel designated by the Investigator should complete data collection. 
Appropriate training and security measures should be completed with all authorized investigation 
study center personnel prior to the study being initiated and any data being entered into the system 
for any subject.
The study data is the sole property of the Sponsor and should not be made available in any form to 
third parties, except for authorized representatives of appropriate RA, without written permission 
from the Sponsor. At the end of the study, electronic data are kept at the Sponsor and a copy 
(provided by the vendor) at the study center as part of the Investigator file.
Any delegation of collection of data should be specified in a signature and delegation log.
All data shall be entered in English. The eCRFs should always reflect the latest observations on the 
subjects participating in the study. Therefore, the eCRFs shall be completed as soon as possible 
during or after the subject’s visit. The subject’s identity must always remain confidential, i.e., the 
name and address of the subjects must not be registered in the eCRFs or in the database. The 
Investigator must verify that all data entries in the eCRFs are accurate and correct. If some 
assessments are not done, or if certain information is not available, not applicable or unknown, the 
Investigator shall indicate this in the eCRF. The Investigator shall electronically sign off the study 
data. By signing, the Investigator takes responsibility for the accuracy, completeness, and legibility 
of the data reported to the Sponsor in the eCRF.
The monitor shall review the eCRFs and evaluate them for completeness and consistency. All 
entries, corrections, and alterations shall be made by the PI or his/her authorized designee. The 
monitor cannot enter data in the eCRFs. Once study data have been submitted to the central server 
via the eCRF, corrections to the data fields will be audit trailed, meaning that the reason for change, 
the name of the person who made the change, together with time and date will be logged. Roles and 
rights of the study center personnel responsible for entering study data into the eCRF shall be 
determined in advance. If discrepant data is detected during review of the data, either by the Sponsor 
or by its representatives, the responsible data manager or monitor shall raise a query in the electronic 
data capture application. The query shall state the question or data to be changed and shall be 
resolved in the system by the PI or his/her authorized designee. The appropriate study center 
personnel shall answer the queries in the eCRF. This will be audit trailed by the electronic data 
capture application meaning that the name of study center personnel, time, and date is logged.
The eCRF records will be automatically appended with the identification of the creator, by means 
of their unique UserID. Specified records shall be electronically signed by the Investigator to 
document his/her review of the data and acknowledgement that the data are accurate. This will be 
facilitated by means of the Investigator’s unique UserID and password; date and time stamps will 
be added automatically at time of electronic signature. If an entry in an eCRF requires change, the 
correction shall be made in accordance with the relevant software procedures. 
All changes will be fully recorded in a protected audit trail and a reason for the change shall be 
stated. Once all data have been entered, verified, and validated, the database will be locked.
10.4.2 Source documentation
Source documents are all documents used by the Investigator or study center that relate to the 
subject’s medical history, that verifies the existence of the subject, the inclusion and exclusion 
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 56 of 67
criteria, and all records covering the subject’s participation in the study. They include laboratory 
notes, memoranda, material dispensing records, subject files, etc.
The Investigator is responsible for maintaining source documents. These should be made available 
for inspection by the monitor at each monitoring visit. The Investigator must submit a completed 
eCRF for each subject for whom signed informed consent has been collected. All supportive 
documentation submitted with the eCRF, such as laboratory or hospital records, should be clearly 
identified with the CTN and subject number. Any personal information, including name, should be 
removed, or rendered illegible to preserve individual confidentiality.
10.4.3 Protection of personal data
The study shall include collection and processing of personal data as specified in the Regulation 
European Union (EU) 2016/679 (General Data Protection Regulation, GDPR) and the regulation 
EU 2017/745 (MDR) on the protection of individuals with regard to the processing of personal data 
and on the free movement of such data, the Personal Information Protection and Electronic 
Documents Act (PIPEDA) in Canada. All processing of personal data must be carried out in 
accordance with national legislation concerning the protection of personal data. The Institution and 
the Investigator are responsible for complying with all requirements pursuant to national legislation 
in which the Institution and the Investigator are located. The Sponsor will ensure that all 
requirements for data processing are fulfilled.
The ICF shall contain information about what personal data to be collected in the study and that this 
will be kept confidential. The provided information shall be sufficient to enable all subjects to give 
their consent not only to the participation in the study, but also to the processing of personal data. 
Such information includes information regarding the purposes of the collecting, processing, data 
transfer to other countries. If a subject decides to terminate the study prematurely, data collected 
before withdrawal of consent will be used in the evaluation of the study, however no new data may 
be collected. Authorized representatives from the Sponsor, CRO or a RA may visit the study center
to perform audits/inspections, including source data verification (SDV), i.e., comparing data in the 
subjects’ medical records and the eCRF. Data and information shall be handled strictly confidential.
10.4.4 Archiving / record keeping
The PI/Institution should permit study-related monitoring, audits, REB review, and RA inspections 
and should provide direct access to the source data/medical record including the identity of all 
participating subjects (sufficient information to link records, i.e., eCRF, medical records, original 
signed ICF and detailed records of study product accountability). The records should be retained by 
the PI as required by local legislation and international guidelines. Any transfer of responsibility for 
storage of the records should be documented and the Sponsor should be informed in writing. 
The Sponsor should verify that each subject has consented in writing to direct access to the original 
medical record/source data (by the use of written subject information and signed informed consent). 
The data recorded in the eCRFs will be checked for consistency with the source documents/medical 
record by the monitor during monitoring SDV. In order to be able to perform SDV, information 
about each subject’s participation in the study has to be detailed in the medical record or other 
relevant source.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 57 of 67
Protocol deviations
The PI is not allowed to deviate from the CSP and no up-front waivers from the CSP will be issued. 
Any CSP deviation shall be documented appropriately, verified, discussed, and collected by the 
monitor and appropriate actions will be taken.
Under emergency circumstances, deviations from the CSP to protect the rights, safety and well-
being of the subjects may proceed without prior approval of the Sponsor and the REB. Such 
deviations should be documented and reported to the REB as soon as possible. Deviations will be 
reviewed to determine the need to amend the CSP or to terminate the study. Handling of CSP 
deviations will be performed as described in the monitoring manual. The PI is responsible for 
promptly reporting any deviations from the CSP that affects the rights, safety or well-being of the 
subject or the scientific integrity of the study, including those which occur under emergency 
circumstances, to the Sponsor (within 24 hours following detection) as well as the REB required. 
Quality control / quality assurance
10.6.1 Clinical Monitoring
On-site monitoring of the study will be arranged by the Sponsor according to GCP guidelines to 
verify that the rights and well-being of the subjects are protected, the reported data are accurate, 
complete, verifiable from source documents, and that the conduct of the study complies with the 
approved CSP, subsequent amendment(s), GCP and the applicable regulatory requirements. Specific 
details about monitoring in the study will be outlined in a separate Monitoring Plan.
10.6.2 Audits / inspections
The study center may be subject to quality assurance audit by the Sponsor as well as inspection by 
appropriate RA. It is important that the PI and other relevant study site personnel are available during 
the monitoring visits, possible audits, and inspections, and that sufficient time is devoted to the 
monitoring process.
Each participating member of the study site team shall provide a curriculum vitae (CV) or equivalent 
that demonstrates their qualifications to conduct the study.
Protocol amendments
10.7.1 Amendments
The PI and other site personnel involved in the study must not implement any changes to the CSP 
without agreement with the Sponsor and prior review and documented approval from the REB, 
except where necessary to eliminate an immediate hazard to the subjects. All changes to the final 
CSP must be documented in a dated and version-controlled written protocol amendment.
Financing, indemnification and insurance
This study is fully sponsored by Galderma LLC and Q-Med AB. The CTA between Sponsor (or the 
CRO) and Investigational sites outlines the compensation and payment terms of the study. The CTA 
must be signed before the first subject is screened in the study. If there are differences between the 
CTA and the CSP regarding certain rights and obligations, the CTA is the prevailing document.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 58 of 67
The Sponsor’s obligations in this clinical study are covered by Galderma’s global general liability 
program. An insurance certificate will be provided upon request. The Institution/PI is obligated to 
maintain insurance coverage for their obligations in the clinical study according to the CTA.
Publication policy
The PI’s, Institution’s, Galderma LLC and Q-Med AB’s obligations regarding intellectual property 
rights, confidentiality, and publications are described in detail in the CTA.
The aim is to submit the results of this study for publication in the public database 
www.ClinicalTrials.gov and to a medical journal for a first joint publication of the results. Everyone 
who is to be listed as an author of the results of this multicenter study shall have made a substantial, 
direct, intellectual contribution to the work. Authorship will be based on (1) substantial contributions 
to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the 
work; and (2) drafting the work or revising it critically for important intellectual content; and (3) 
final approval of the version to be published; and (4) agreement to be accountable for all aspects of the 
work in ensuring that questions related to the accuracy or integrity of any part of the work are 
appropriately investigated and resolvedV. Conditions 1, 2, 3, and 4 must all be met in order to be 
designated as author. Those who do not meet all four criteria will be acknowledged. Among the 
authors that fulfil the above-mentioned criteria, one author will be appointed by Galderma LLC and 
Q-Med AB to take primary responsibility for the overall work as primary author.
                                                
V Defining the role of authors and contributors, compiled by the International Committee of Medical Journal Editors 
(ICMJE) (http://www.icmje.org).
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 59 of 67
11. REFERENCES
1.
Reece EM, Rohrich RJ. The aesthetic jaw line: management of the aging jowl. Aesthet Surg J. 2008 Nov-
Dec;28(6):668-74. 
2.
Moradi A, Shirazi A, David R. Nonsurgical Chin and Jawline Augmentation Using Calcium Hydroxylapatite and 
Hyaluronic Acid Fillers. Facial Plast Surg. 2019 Apr;35(2):140-148.
3.
Yutskovskaya YA, Sergeeva AD, AI K, Marina. L. Contouring of Lower Face and Chin in Consideration of Facial 
Morphotypes and Shapes- Is it a More Accurate Approach?: Madridge Journal of Dermatology & Research; 2017. 
p. 26-31.
4.
Wat H, Wu DC, Goldman MP. Noninvasive Body Contouring: A Male Perspective. Dermatol Clin. 2018;36(1):49-
55.
5.
Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 
Jun;124(6):869-71.
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 60 of 67
12. Appendices
Appendix 1
Galderma Jawline Scale (GJS)
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 61 of 67
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 62 of 67
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 63 of 67
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 64 of 67
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 65 of 67
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
CCI

CONFIDENTIAL
Page 66 of 67
SIGNED AGREEMENT OF THE CLINICAL STUDY PROTOCOL
CTN:
05DF2209
Title of the CSP:
A randomized, evaluator-blinded, parallel group, no treatment 
controlled, multicenter study to evaluate effectiveness and safety of 
Restylane Lyft Lidocaine for jawline definition.
I, the undersigned, have read and understand the CSP specified above, and agree on the contents. 
The CSP, the clinical trial agreement (CTA) and the additional information given in the instructions 
for use (IFU) will serve as a basis for co-operation in this study.
Principal Investigator
Printed name 
Signature
Date
Study center
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48

CONFIDENTIAL
Page 67 of 67
SPONSOR SIGNATURES
The Clinical Study Protocol is electronically signed in the document management system within 
the Q-Med AB quality management system by the representatives listed below.
Senior Medical Expert:
, MD, MPH
Head of Clinical Project Management:
, MBA
Global Head of Clinical Scientists:
 PhD
Head of Medical Affairs Strategy Ax
, MD
Senior Clinical Scientist:
, MSc
Statistician:
, MSc
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
PPD
PPD
PPD
PPD
PPD
PPD

Sign page:1 of 1
SIGNATURES PAGE
Date
Signed by
2022-10-20 16:59
Justification
Compiled by
2022-10-20 18:46
Justification
Approved by Technical Expert
2022-10-21 09:30
Justification
Approved by Owner
2022-10-21 09:59
Justification
Approved by
2022-10-21 10:51
Justification
Approved by Medical Affairs
2022-10-21 11:05
Justification
Approved by Technical Expert
Title 
Doc id  
05DF2209, Clinical Study Protocol R Lyft Jawline CA
MA-52559
 
Effective date: 
 
Version: 
Effective
 2022-10-21 11:05
1.0
Print date:
 2022-10-27 21:48
PPD
PPD
PPD
PPD
PPD
PPD