Clinical trial NCT03880058
Conditions: Scars
Sponsor: Scarless Laboratories, Inc.
Start date: 2019-03-03; Completion date: 2021-05-18
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicenter, double-blind study comparing SLI-F06 to vehicle formulation buffer for the improvement in scar appearance and wound strength in routine surgical excisions, as well as post-operative abdominoplasty scar appearance.

Detailed description:
The study is divided into 2 parts where Part A is a Phase I safety/proof of concept study of small scars pre-abdominoplasty, and Part B is a Phase IIa study of post-abdominoplasty scars.

In Part A of the study, subjects will have their abdominoplasty site mapped to accommodate a series of excisions depending on pannus size. All excisions to be treated with SLI-F06 will be on one side of the mapped area (i.e., left side or right side) and vehicle treated excisions will be on the other side of the mapped area. At time of abdominoplasty the excision site will be harvested and processed.

In Part B of the study, subjects who complete Part A will be randomly assigned to receive injections of SLI-F06 along one half (left or right) of the abdominoplasty incision and control injections along the other half. The subject will undergo routine wound care and will attend study follow-up visits following abdominoplasty. The entire incision will be treated post-operatively in precisely the same manner.

Duration of study-approximately 26 months.

Arms: arm 1: Drug Product under investigation arm 2: Placebo
Interventions: intervention 1: SLI-F06 intervention 2: Formulation buffer
Intervention descriptions: intervention 1: Active treatment intervention 2: Placebo treatment

Protocol documents:
Prot_000.pdf: 
Scarless Laboratories Inc. 
Protocol SLI-C40-01 
CONFIDENTIAL 
NCT03880058 
v.1.4; 20-Nov-2020 
Page 1 of 53 
 
 
 
Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in 
Pre-Abdominoplasty Surgical Excisions and Post-Operative Scar Appearance 
in Subjects Undergoing Abdominoplasty 
 
Phase I/IIa  
 
Protocol:   SLI-C40-001 
Version:   v.1.4 
Date:   20-Nov-2020 
 
Previous Version: v.1.3; 15-Jan-2019 
 
 
Study Sponsor: 
Scarless Laboratories Inc. 
369 South Doheny Drive, Suite 1201 
Beverly Hills, CA 
USA 90211 
 
 
 
Clinical Research Organization:  
ethica CRO Inc. 
8555 Transcanada Hwy, Suite 201 
Montreal, Canada H4S 1Z6 
 
 
 
 
 
 
Confidentiality Statement 
The information contained in this document is provided in confidence. It is understood 
that this information will not be disclosed to others without prior agreement with the 
Sponsor, except to other study personnel and to the extent necessary to obtain informed 
consent from participating subject. 
 


Scarless Laboratories Inc. 
Protocol SLI-C40-01 
CONFIDENTIAL 
NCT03880058 
v.1.4; 20-Nov-2020 
Page 2 of 53 
PROTOCOL APPROVAL SIGNATURE PAGE 
 
The following individuals approve this version of Protocol SLI-C40-001. All changes to this 
version of the protocol must have a prior written approval and require an amendment or 
administrative letter. 
 
Accepted for the Sponsor – Scarless Laboratories Inc. 
___________________________  ______________________________  
Printed Name 
Title 
___________________________  ______________________________   
Signature 
Date 
 
 
Accepted for the Clinical Research Organization - ethica CRO Inc. 
___________________________  ______________________________  
Printed Name 
Title 
___________________________  ______________________________   
Signature 
Date 
 
 
 


Scarless Laboratories Inc. 
Protocol SLI-C40-01 
CONFIDENTIAL 
NCT03880058 
v.1.4; 20-Nov-2020 
Page 3 of 53 
INVESTIGATOR SIGNATURE PAGE 
 
I agree to: 
• Implement and conduct this study diligently and in strict compliance with the protocol, good 
clinical practices and all applicable laws and regulations. 
• Maintain all information supplied by Scarless Laboratories Inc. in confidence and, when this 
information is submitted to an Institutional Review Board (IRB) or another group, it will be 
submitted with a designation that the material is confidential. 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
Principal Investigator (Printed Name) 
 
Signature 
 
Date 
 
 
 
 


Scarless Laboratories Inc. 
Protocol SLI-C40-01 
CONFIDENTIAL 
NCT03880058 
v.1.4; 20-Nov-2020 
Page 4 of 53 
SYNOPSIS 
Protocol 
Version 
Version 1.4 (13-Nov-2020) 
Investigational 
Product: 
SLI-F06 
Study Number 
SLI-C40-001 
Phase 
Phase I - Safety/Proof of Concept (Part A) 
Phase IIa - Safety and Efficacy (Part B and Part B 
Extension) 
Control 
Treatment: 
Formulation Buffer 
(vehicle) 
Indication 
Intradermal injection for improvement of wound 
healing and post-operative scar appearance  
Study Sites:  
Approximately 3-4 sites 
Title 
Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in Pre-Abdominoplasty 
Surgical Excisions and Post-Operative Scar Appearance In Subjects Undergoing Abdominoplasty 
Sponsor 
Scarless Laboratories Inc. 
Study 
Duration 
Approximately 13.5 to 24 months per subject 
Number of 
Subjects 
Approximately 25 subjects 
Treatment 
Groups 
During Part A of the study, subjects will be randomized by side of the pannus (right or left) (see Section 
6.2) for treatment with SLI-F06 or formulation buffer, wound tension (high or low), and by duration 
of follow-up post-excisions to 12 weeks (group 1) or  8 weeks (group 2) pre-abdominoplasty. Excision 
mapping and number of excisions will be determined by size of pannus as follows: 
• 
Small pannus: 25 cm length x 12 cm height mapping 
6 small wounds (3 cm length x 1 cm width) and 6 large wounds (3 cm length x 2 cm width) will 
be generated per subject. 12 wounds per subject. 
• 
SLI-F06 at 6 excision sites (3 high tension, 3 low tension) 
• 
Formulation buffer at 6 excision sites (3 high tension, 3 low tension) 
• 
Medium pannus: 30 cm length x 14 cm height mapping 
6 small wounds (3 cm length x 1 cm width) and 8 large wounds (3 cm length x 2 cm width) will 
be generated per subject. 14 wounds per subject. 
• 
SLI-F06 at 7 excision sites (4 high tension, 3 low tension) 
• 
Formulation buffer at 7 excision sites (4 high tension, 3 low tension) 
• 
Large pannus: 32 cm length x 18 cm height mapping 
8 small wounds (3 cm length x 1 cm width) and 10 large wounds (3 cm length x 2 cm width) 
will be generated per subject. 18 wounds per subject. 
• 
SLI-F06 at 9 excision sites (5 high tension, 4 low tension) 
• 
Formulation buffer at 9 excision sites (5 high tension, 4 low tension) 
During Part B of the study, after undergoing abdominoplasty, subjects will be randomized by side of 
the incision (right or left), and will receive injections of SLI-F06 into one half of their abdominoplasty 
incision and injections of vehicle formulation buffer into the other half of their incision. 
During Part B Extension, no SLI-F06 or formulation buffer will be administered. It is an observational 
extension of the study. 
Study Design 
This is a multicenter, double-blind study comparing the safety of SLI-F06 to control formulation buffer 
(vehicle), as well as comparing the improvement in scar appearance and wound strength. Each subject 
will serve as his or her own control. 
The study is divided into 2 parts where Part A is a Phase I safety/proof of concept study of small scars 
pre-abdominoplasty, and Part B is a Phase IIa study of post-abdominoplasty scars. In Part A of the 
study (i.e., Phase I safety/proof-of-concept), subjects desiring abdominoplasty and who consent to 
participate in the study will have their abdominoplasty site mapped to accommodate 12, 14 or 18 
excisions depending on pannus size for standardized 3 cm length excisions (see Section 6.5). 
Subjects will be allocated to 2 groups with different durations of post-excision follow-up (i.e., 12 weeks 
or 8 weeks pre-abdominoplasty) according to when they were enrolled into the study.  All participants 
will be enrolled in or transferred to the 12-week pre-abdominoplasty group (Group 1). However, if 


Scarless Laboratories Inc. 
Protocol SLI-C40-01 
CONFIDENTIAL 
NCT03880058 
v.1.4; 20-Nov-2020 
Page 5 of 53 
consented participants, who are assigned to Group 2 (8-week pre-abdominoplasty), cannot transfer to 
Group 1, they will remain in Group 2. Each excision site will be treated post-operatively in precisely 
the same manner. Following completion of the follow-up period, the entire abdominoplasty site will 
be harvested and sent for analyses of histopathology and tensile strength. 
In Part B of the study (i.e., Phase IIa), ALL subjects who complete Part A will be randomly assigned 
to receive injections of SLI-F06 along one half (left or right) of the abdominoplasty incision and control 
injections along the other half. Injections will be on both sides of the incision. The subject will undergo 
routine wound care and will attend study follow-up visits following abdominoplasty at Day 8 and at 
Months 1, 2, 3, 6, 9, and 12. 
Participants will then be invited to participate in an observational extension of the study, Part B 
Extension. Numbering and timing of study visits will be extended from Visit 8b (M12) of Part B. The 
subject will attend study visits at Months 15, 18, 21 and 24 where they will undergo POSAS 
assessments (PI and Subject) and abdominal photography. No further treatments will be administered 
during this observational extension of the study. 
Objectives 
Primary objectives: 
• 
Part A: Assess the safety and tolerability of SLI-F06 in the treatment of planned surgical 
excisions. 
• 
Part B: Assess the safety and tolerability of SLI-F06 in the treatment of abdominoplasty 
incisions. 
• 
Part B Extension: Assess the efficacy of SLI-F06 treatment on the appearance of 
abdominoplasty incision scars. 
Secondary objectives: 
• 
Part A: 
- 
Assess the effect of SLI-F06 on scar appearance. 
- 
Assess the effect of SLI-F06 on wound strength. 
- 
Assess the effect of SLI-F06 on histological appearance of scars. 
- 
Assess immunogenicity effects of SLI-F06. 
• 
Part B: 
- 
Assess the effect of SLI-F06 on post-operative abdominoplasty scar appearance. 
- 
Assess immunogenicity effects of SLI-F06. 
• 
Part B Extension: 
- 
None 
Inclusion 
Criteria (Parts 
A and B) 
1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of childbearing 
potential must have a negative UPT at Visit 1a and 1b and practice a reliable method of 
contraception 
2. Seeking or scheduled for standard elective abdominoplasty. 
3. Willing to undergo directed excisions and follow-up prior to abdominoplasty and to undergo all 
follow-up visits after abdominoplasty. 
4. Willing to undergo directed excisions under local anesthetic (i.e., does not require general 
anesthetic). 
5. Be able to follow study instructions and likely to complete all required visits. 
6. Sign the IRB-approved ICF (which includes the Photographic Release Form and HIPAA) prior 
to any study-related procedures being performed. 
Inclusion 
Criteria (Part 
B Extension) 
1. Current or previous participant in Part B of Study SLI-C40-001. 
2. Sign the IRB-approved ICF (which includes the Photographic Release Form and HIPAA) prior to 
any study-related procedures being performed. 
Exclusion 
Criteria 
(Parts A and 
B) 
1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing 
reliable birth control (as specified in Section 5.1). 
2. Known hypersensitivity or previous allergic reaction to any constituent of the IP (i.e., SLI-F06). 
3. History of diabetes mellitus or an HgB A1C greater than 5.7 percent. 
4. Morbid obesity (i.e., BMI >40). 


Scarless Laboratories Inc. 
Protocol SLI-C40-01 
CONFIDENTIAL 
NCT03880058 
v.1.4; 20-Nov-2020 
Page 6 of 53 
5. History of prior abdominal surgery. 
6. History of abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction 
procedures in or near the anterior abdomen within 12 months of Visit 2a. 
7. History of poor or delayed wound healing such as a prior wound dehiscence, chronic wound or 
leg ulcer. 
8. History of or evidence of a genetic collagen disorder such as Ehlers-Danlos syndrome. 
9. Operating Physician unable to design an abdominoplasty incision area of at least 25 cm wide by 
12 cm tall at the center of the fusiform. 
10. The presence of any abnormality of the skin within the area of the proposed abdominoplasty that, 
in the opinion of the Principal Investigator (PI), could interfere with the excision process or 
grading of the resultant surgical scar. 
11. Use of any concomitant medications/procedures or tobacco/inhaled nicotine products specified in 
Section 6.7.1 within a restricted time period. 
12. Allergy to or intolerance of local anesthetics. 
13. Medical or psychiatric conditions that may increase the risk associated with study participation or 
may interfere with interpretation of study results or compliance of the subject and, in the opinion 
of the PI, would make the subject inappropriate for study entry. 
14. Any personal, familial, employment or financial situation that could impede the subject’s ability 
to attend all study visits and successfully complete the entire clinical study. 
15. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. 
16. Exposure to any other investigational drug/device within 30 days prior to study entry. 
Exclusion 
Criterion (Part 
B Extension) 
1. None 
Drug 
Administration 
The solution of SLI-F06 or vehicle solution will be injected intradermally into BOTH edges of the 
surgical wound immediately prior to closure (Part A) and after closure (Part B). The concentration of 
SLI-F06 will be 25 mg/ml.  
In Part A, a total of 0.4 mL (10 mg) will be injected at each excision site. A total of 0.2 mL (5 mg) will 
be injected along EACH SIDE of the wound edge. As each wound edge is 3 cm in length, 0.05 mL 
will be injected per 0.75 cm of wound edge). The total exposure of SLI-F06 for subjects with small 
pannus will be approximately 60 mg (6 treated excisions), for subjects with a medium pannus will be 
approximately 70 mg (7 treated excisions), and for subjects with a large pannus will be approximately 
90 mg (9 treated excisions). 
In Part B of the study, 0.05 mL will be injected per 0.75 cm of wound edge as above. A subject with 
an incision length of 25 cm (12.5 cm active treatment) would be exposed to 41.6 mg of SLI-F06, while 
subjects with an incision lengths of 30 cm (15 cm active treatment) or 32 cm (16 cm active treatment) 
would be exposed to 50 mg or 53.3 mg, respectively. 
In Part B Extension, there will be no exposure to SLI-F06 or vehicle solution. 
Blinding 
Subjects, PIs and study coordinators will be blinded to treatment assignments of vehicle versus active 
IP. Subjects may or may not be blinded to low or high wound tension; PIs will not be blinded to the 
degree of wound tension. 
A member of the site staff will be designated as the unblinded Independent Drug Reconstitutor (IDR). 
The IDR will consult a randomization schedule and prepare syringes of active product and vehicle 
(formulation buffer). Syringes will be labeled “left side” or “right side”. 
Procedures 
Refer to the Study Summary Table for a schedule of activities. 
Efficacy 
Evaluations 
Primary 
• Patient and Observer Scar Assessment Scale (POSAS; PI Assessment) – Excisions and  
Abdominoplasty Incisions (Parts A, B, Part B Extension) 
Secondary 
• POSAS (Subject Assessment) – Abdominoplasty Incisions (Part B and Part B Extension) 


Scarless Laboratories Inc. 
Protocol SLI-C40-01 
CONFIDENTIAL 
NCT03880058 
v.1.4; 20-Nov-2020 
Page 7 of 53 
• POSAS (PI Assessment) – Abdominoplasty 5 cm Segments (Part B and Part B Extension) 
• POSAS (Subject Assessment) – Abdominoplasty 5 cm Segments (Part B and Part B Extension) 
• Independent Panel Review of scar photography using POSAS 
• Excision site histology 
• Tensile strength of scar 
Exploratory 
• POSAS (Subject Assessment) – Excisions (Part A) 
Safety 
Evaluations 
• Adverse Events (Part A and Part B) 
• Treatment Related Adverse Events (Part B Extension)  
• Clinical safety laboratory tests 
• Immunogenicity 
Sample Size 
Approximately 25 subjects will be enrolled. This is a Phase I safety/proof-of-concept + Phase IIa study 
and a formal sample size justification is not required. It is the opinion of the Sponsor that a total of 25 
subjects will be sufficient to achieve the objectives of the study. 
Statistical 
Methods 
All statistical processing will be performed using SAS® version 9.4 or later unless otherwise stated. 
Statistical significance will be based on two-tailed tests of the null hypothesis resulting in p-values of 
0.05 or less. For categorical parameters, the number and percentage of subjects or observations in each 
category will be presented. The denominator for percentage will be based on the number of subjects or 
observations appropriate for the purpose of analysis. For continuous parameters, descriptive statistics 
will include n (number of subjects or observations), mean, standard deviation, median, and range. 
Comparisons between treatment groups will be performed using parametric or non-parametric testing, 
as appropriate. Statistical analyses will be conducted on an intent-to-treat (ITT) basis. An interim 
analysis will be conducted when all subjects have completed Study Part A. 


Scarless Laboratories Inc. 
  
Protocol SLI-C40-0 
CONFIDENTAIL 
v.1.4; 20-Nov-2020 
Page 8 of 53 
 
 
 
 
STUDY SUMMARY 
 
 
1 UPT if female of childbearing potential and if last UPT performed >7 days of V2a. 
2 Safety laboratory results to be reviewed by the PI prior to excisions in order to confirm absence of any health condition(s) that would make the subject inappropriate for study entry. 
3 Day 1 photography occurs prior to excisions and following closure of all excisions, and Day 8 photography occurs pre- and post-removal of sutures. 
4 Only currently enrolled participants who cannot be moved from group 2 to group 1 will remain in group 2 
5 First Part B extension visit can occur at any of these timepoints. Consent to be obtained during the first visit of Part B extension if not obtained at Visit 8b.  
6 First Part B extension visit can occur at any of these timepoints. Inclusion/Exclusion criteria to be reviewed during the first visit of Part B extension.  
7 Only Treatment Related AE (TRAE) will be assessed. 
 
Part A (Phase I Safety/Proof of Concept) 
Part B (Phase IIa) 
Part B Extension  
Visit Number 
1a 
2a 
3a 
4a 
5a 
6a 
1b 
2b 
SR 
3b 
4b 
5b 
6b 
7b 
8b 
9b 
10b 
11b 
12b 
Optional 
Visit 
Assessment and Procedures 
Screening 
Period 
Excisions 
Suture 
Removal  
 
  
 
Abdomin-
oplasty 
 
 
Suture 
Removal 
 
 
 
 
 
 
 
 
 
 
 
D -30 
to 0 
D1 
D8 
± 1d 
D29 
± 2d 
D57 
± 3d 
D85 
± 3d 
D0 
D8 
± 1d 
PI 
Discretion 
M1 
± 3d 
M2 
± 7d 
M3 
± 14d 
M6 
± 14d 
M9 
± 14d 
M12 
± 14d 
M15 
± 14d 
M18 
± 14d 
M21 
± 14d 
M24 
± 14d 
-- 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X5 
X5 
X5 
 
X5 
Inc/Excl Criteria Parts A and B 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inc/Excl Criteria Part B Extension 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X6 
X6 
X6 
 
X6 
Medical/Surgical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Exam 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Test 1 
X 
X 1 
 
 
 
 
X 
 
 
 
 
X 
X 
X 
X 
 
 
 
 
 
Abdominoplasty Area Assessment 
& selection of Pannus Map size 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Immunogenicity sampling 
X 
 
X 
X 
X 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Safety Laboratory Testing 2 
X 2 
 
 
X 
Group 2 
Group 1 
 
 
 
X 
 
 
 
 
X 
 
 
 
 
 
Photography 3 
 
X 3 
X 3 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Randomization 
 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Excisions 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IP Injections 
 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Abdominoplasty/ Tissue 
Harvesting 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Suture removal 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
POSAS grading (PI & Subject) 
 
 
Post-removal 
of sutures 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
AE Assessment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X7 
X7 
X7 
X7 
X7 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Group 1; 12 week assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exit from Part A / Start of Part B 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group 2; 8 week assessment4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exit from Part A / Start of Part B 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


Scarless Laboratories Inc.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Protocol SLI-C40-001 
CONFIDENTIAL 
v.1.4; 20-Nov-2020 
Page 9 of 53 
 
TABLE OF CONTENTS 
 
PROTOCOL APPROVAL SIGNATURE PAGE ............................................................................................... 2 
INVESTIGATOR SIGNATURE PAGE .............................................................................................................. 3 
SYNOPSIS .............................................................................................................................................................. 4 
STUDY SUMMARY .............................................................................................................................................. 8 
CONTACT LIST ................................................................................................................................................. 12 
ABBREVIATIONS AND DEFINITIONS ......................................................................................................... 13 
1 
INTRODUCTION ....................................................................................................................................... 14 
2 
STUDY OBJECTIVES ................................................................................................................................ 15 
3 
COMPLIANCE STATEMENT .................................................................................................................. 16 
3.1 
Variations to the Protocol ..................................................................................................................... 16 
3.2 
Investigational Sites .............................................................................................................................. 16 
3.3 
Medical Monitor ................................................................................................................................... 16 
4 
OVERVIEW OF STUDY DESIGN ............................................................................................................ 17 
4.1 
Study Design ......................................................................................................................................... 17 
4.2 
Study Design Rationale ......................................................................................................................... 17 
4.2.1 
Study Population ................................................................................................................................................ 17 
4.2.2 
Primary Effectiveness Outcome Measurements ................................................................................................. 17 
5 
STUDY POPULATION .............................................................................................................................. 18 
5.1 
Inclusion Criteria .................................................................................................................................. 18 
5.1.1 
Part A and Part B ............................................................................................................................................... 18 
5.1.2 
Part B Extension: ............................................................................................................................................... 18 
5.2 
Exclusion Criteria ................................................................................................................................. 18 
5.2.1 
Parts A and B ..................................................................................................................................................... 18 
5.2.2 
Part B Extension ................................................................................................................................................ 19 
5.3 
Subject Withdrawal Criteria ................................................................................................................. 19 
6 
TREATMENT PLAN .................................................................................................................................. 21 
6.1 
Subject Numbering ................................................................................................................................ 21 
6.2 
Randomization ...................................................................................................................................... 21 
6.3 
Blinding ................................................................................................................................................. 21 
6.4 
Unblinding ............................................................................................................................................ 21 
6.5 
Pannus Excision Sites - Study Part A .................................................................................................... 21 
6.5.1 
Excision Sites..................................................................................................................................................... 21 
6.5.2 
Pannus Map and Excision Template .................................................................................................................. 22 
Figure 1. Small Pannus Map ............................................................................................................................. 22 
Figure 2. Medium Pannus Map.......................................................................................................................... 22 
Figure 3. Large Pannus Map ............................................................................................................................. 23 
6.5.3 
Excision Site Mapping ....................................................................................................................................... 23 
6.5.4 
Sequence of Excisions ....................................................................................................................................... 24 
6.5.5 
Pre-operative Preparation and Patient Monitoring ............................................................................................. 24 
6.5.6 
Anesthetic Preparation and Administration ....................................................................................................... 24 
6.5.7 
Excision Procedures ........................................................................................................................................... 24 
6.5.8 
Administration of Investigational Product (Excisions) ...................................................................................... 25 
6.5.9 
Wound Care (Excisions) .................................................................................................................................... 25 
6.6 
Abdominoplasty Incision – Study Part B ............................................................................................... 26 
6.6.1 
Surgical Preparation and Patient Monitoring ..................................................................................................... 26 
6.6.2 
Surgical Anesthesia ............................................................................................................................................ 26 
6.6.3 
Abdominoplasty Surgery ................................................................................................................................... 26 
6.6.4 
Administration of Investigational Product (Abdominoplasty) ........................................................................... 26 


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v.1.4; 20-Nov-2020 
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Figure 5. Injection of the abdominoplasty incision ............................................................................................ 27 
6.6.5 
Wound Care (Abdominoplasty) ......................................................................................................................... 27 
6.7 
Observational Extension - Part B Extension ......................................................................................... 27 
6.7.1 
Participant Recruitment ..................................................................................................................................... 27 
6.8 
Concomitant Medications and Procedures ........................................................................................... 27 
6.8.1 
Prohibited Treatment and Procedures ................................................................................................................ 27 
7 
STUDY DRUG MATERIALS AND MANAGEMENT ............................................................................ 29 
7.1 
SLI-F06 (Investigational Product) ........................................................................................................ 29 
7.2 
Formulation Buffer ............................................................................................................................... 29 
7.3 
Packaging and Labeling ....................................................................................................................... 29 
7.4 
Storage, Handling, and Disposal of Investigational Product ............................................................... 29 
7.5 
Dosing and Administration ................................................................................................................... 29 
8 
DATA COLLECTION ................................................................................................................................ 30 
8.1 
Electronic Case Report Form ............................................................................................................... 30 
8.2 
Laboratory Data ................................................................................................................................... 30 
8.3 
Photography .......................................................................................................................................... 30 
9 
STUDY EVALUATIONS ............................................................................................................................ 31 
9.1 
Informed Consent .................................................................................................................................. 31 
9.2 
Study Part A .......................................................................................................................................... 31 
9.2.1 
Visit 1a (Screening Period; Day -30 to 0) .......................................................................................................... 31 
9.2.2 
Visit 2a (Abdominal Excisions; Day 1) ............................................................................................................. 31 
9.2.3 
Visit 3a (Suture Removal; Day 8; ±1 day) ......................................................................................................... 31 
9.2.4 
Visit 4a (Day 29; ±2 days) ................................................................................................................................. 31 
9.2.5 
Visit 5a (Day 57; ±3 days) ................................................................................................................................. 32 
9.2.6 
Visit 6a (Day 85; ±3 days) ................................................................................................................................. 32 
9.3 
Study Part B .......................................................................................................................................... 32 
9.3.1 
Visit 1b (Day 0; Abdominoplasty) ..................................................................................................................... 32 
9.3.2 
Visit 2b (Day 8; ±1 day) .................................................................................................................................... 32 
9.3.3 
Suture Removal Visit (Timing of visit at the discretion of the Investigator) ..................................................... 32 
9.3.4 
Visit 3b (Month 1 ± 3d) ..................................................................................................................................... 32 
9.3.5 
Visit 4b, 5b, 6b, and 7b (Month 2 ± 7d, Months 3, 6, and 9 ± 14d) ................................................................... 33 
9.3.6 
Visit 8b (Months 12 ± 14d) ................................................................................................................................ 33 
9.4 
Study Part B Extension .......................................................................................................................... 33 
9.4.1 
Visit 9b, 10b, and 11b (Months 15, 18, 21 ± 14d) ............................................................................................. 33 
9.4.2 
Visit 12b (Month 24 ± 14d) ............................................................................................................................... 34 
9.4.3 
Study Exit .......................................................................................................................................................... 34 
9.4.4 
Optional Visit..................................................................................................................................................... 34 
9.5 
Efficacy ................................................................................................................................................. 34 
9.5.1 
Primary Efficacy Variable ................................................................................................................................. 34 
9.5.1.1 
POSAS (PI Assessment) – Excisions/Abdominoplasty Incisions (Parts A, B, and B Extension) ......... 34 
9.5.2 
Secondary Efficacy Variables ............................................................................................................................ 34 
9.5.2.1 
POSAS (Subject Assessment) – Abdominoplasty Incisions (Parts B and B Extension) ....................... 34 
9.5.2.2 
POSAS (PI assessment) – Abdominoplasty 5 cm sections (Parts B and B Extension) ......................... 35 
9.5.2.3 
Independent Panel Review - Photography ............................................................................................ 35 
9.5.2.4 
Histology .............................................................................................................................................. 35 
9.5.2.5 
Tensile Strength .................................................................................................................................... 35 
9.5.3 
Exploratory Efficacy Variables .......................................................................................................................... 36 
9.5.3.1 
POSAS (Subject Assessment) – Excisions (Part A) ............................................................................. 36 
9.6 
Safety ..................................................................................................................................................... 36 
9.6.1 
Clinical Safety Laboratory Tests ........................................................................................................................ 36 
9.6.2 
Immunogenicity Testing .................................................................................................................................... 36 
9.6.3 
Adverse Events .................................................................................................................................................. 36 
9.6.3.1 
Definition of Adverse Event ................................................................................................................. 36 
9.6.3.2 
Documenting Adverse Experiences ...................................................................................................... 37 
9.6.3.3 
Serious Adverse Events ........................................................................................................................ 38 
9.6.3.4 
Assessment of Severity ......................................................................................................................... 38 


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9.6.3.5 
Assessment of Causality ....................................................................................................................... 39 
9.6.3.6 
Reporting of Serious Adverse Events ................................................................................................... 39 
9.6.3.7 
Expedited Serious Adverse Event Reports ........................................................................................... 39 
9.6.3.8 
Pregnancy ............................................................................................................................................. 40 
10 STATISTICS ................................................................................................................................................ 41 
10.1 
Sample Size Determination ................................................................................................................... 41 
10.2 
Assessments of Efficacy ......................................................................................................................... 41 
10.3 
Assessment of Safety .............................................................................................................................. 41 
10.3.1 Adverse Events .................................................................................................................................................. 41 
10.3.2 Safety Laboratory Tests ..................................................................................................................................... 42 
10.3.3 Immunogenicity ................................................................................................................................................. 42 
10.3.4 Concomitant Medications .................................................................................................................................. 42 
10.4 
Analysis Populations ............................................................................................................................. 42 
10.4.1 Primary Population for Efficacy Analysis ......................................................................................................... 42 
10.4.2 Populations for Safety Analysis ......................................................................................................................... 42 
10.4.3 Sub-Populations ................................................................................................................................................. 42 
10.5 
Subject Disposition ............................................................................................................................... 42 
10.6 
Protocol Deviations and Violations ...................................................................................................... 42 
10.7 
Multicenter Issues ................................................................................................................................. 42 
10.8 
Missing Efficacy Data Imputations ....................................................................................................... 42 
10.9 
Statistical Hypothesis Testing and Control of Multiplicity ................................................................... 42 
10.10 Compliance ........................................................................................................................................... 43 
10.11 Interim Analyses .................................................................................................................................... 43 
11 QUALITY CONTROL AND QUALITY ASSURANCE .......................................................................... 44 
11.1 
Study Monitoring ................................................................................................................................... 44 
11.2 
Audits and Inspections .......................................................................................................................... 44 
11.3 
Protocol Deviations .............................................................................................................................. 44 
12 ETHICS AND ADMINISTRATIVE ISSUES ............................................................................................ 46 
12.1 
Ethical Conduct of the Study ................................................................................................................. 46 
12.2 
Ethics Review ........................................................................................................................................ 46 
12.3 
Written Informed Consent ..................................................................................................................... 46 
12.4 
Subject Data Protections ....................................................................................................................... 46 
12.5 
Data Monitoring Committee ................................................................................................................. 46 
12.6 
Financial Disclosure ............................................................................................................................. 46 
12.7 
Investigator Obligation ......................................................................................................................... 46 
12.8 
Changes to the Protocol ........................................................................................................................ 46 
12.9 
Confidentiality Regarding Study Subjects ............................................................................................. 47 
12.10 Information to Study Personnel ............................................................................................................. 47 
12.11 Reporting and Publication of Results .................................................................................................... 47 
12.12 Financing and Insurance ...................................................................................................................... 47 
13 DATA HANDLING AND RECORD KEEPING ....................................................................................... 48 
13.1 
Case Report Form ................................................................................................................................. 48 
13.2 
Inspection of Records ............................................................................................................................ 48 
13.3 
Archiving of Study Documentation ....................................................................................................... 49 
14 APPENDICES .............................................................................................................................................. 50 
APPENDIX A: PROTOCOL VERSION HISTORY ........................................................................................ 51 
APPENDIX B: PATIENT AND OBSERVER SCAR ASSESSMENT SCALE.............................................. 53 


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CONTACT LIST 
Medical Monitor 
Stacy Smith, MD 
2371 Lagoon View Drive 
Cardiff By The Sea, CA 92007 
Phone: 619.787.5723 
Fax:  619.342.7428 
ssmith@stacyrsmithmd.com 
 
Sponsor Contact 
Carol H Danielson, MS, DrPH 
Scarless Laboratories, Inc. 
369 South Doheny Dr. 
Suite 1201 
Beverly Hills, CA  90211 
Phone: 520.907.5193 
cdanielson@scarlessslabs.com 
 
eCRO Clinical Project Manager 
Sara Kasem 
ethica CRO Inc. 
8555 Transcanada Hwy, Suite 201 
Montreal, Quebec, H4S 1Z6 
Phone:  514.531.2315 
Fax:   514.336.1142 
skasem@ethicacro.com 
 
eCRO Managing Director 
Murray Jensen, MSc 
ethica CRO Inc. 
8555 Transcanada Hwy, Suite 201 
Montreal, Quebec, H4S 1Z6 
Phone:  514.262.9398 
Fax:   514.336.1142 
mjensen@ethicaCRO.com 
 
 
 
24-Hour Emergency Phone Number 
ethica CRO Inc.  
514-262-9398 
 
NOTE: Changes in the names, addresses or telephone numbers of these contacts will be considered 
administrative and will not require a protocol amendment before being implemented. 
 


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ABBREVIATIONS AND DEFINITIONS 
Abdominoplasty 
excision area  
The entire area of skin and subcutaneous tissue that is planned to be excised during the abdominoplasty 
procedure. The abdominoplasty excision area will contain 12-18 excision sites. 
AE 
Adverse Event 
BL 
Baseline 
BMI 
Body Mass Index 
CFR 
U. S. Code of Federal Regulations 
CTR 
Common Treatment Response 
CRO 
Clinical Research Organization 
DHHS 
Department of Health and Human Services 
DP 
Drug Product 
Excision site  
A mapped area designated for a single excision. 
eCRF 
electronic Case Report Form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practices 
HgB 
Hemoglobin 
HIPAA 
Health Insurance Portability and Accountability Act 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IDR 
Independent Drug Reconstitutor 
IP 
Investigational Product 
IPR 
Independent Panel Review 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
LLT 
Lowest Level Term 
MedDRA 
Medical Dictionary for Regulatory Activities 
NSAID 
Non-steroidal anti-inflammatory drug 
OP 
Operating Physician (typically also the PI) 
PI 
Principal Investigator (typically also the OP) 
POC 
Proof Of Concept 
POSAS 
Patient and Observer Scar Assessment Scale 
PP 
Per protocol 
PT 
Preferred Term 
SAE 
Serious Adverse Event 
SAFT 
Safety 
SAP 
Statistical Analysis Plan 
SAS 
Statistical Analysis Software 
SDs 
Source Documents 
SOC 
System Organ Class 
TAN 
Treatment Assignment Number 
TRAE 
Treatment Related Adverse Event 
Tx 
Treatment 
UPT 
Urine Pregnancy Test 
USP 
United States Pharmacopeia 
 
 


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1 
INTRODUCTION 
SLI-F06 is a synthetic 40-amino acid peptide that is being developed as a treatment to promote 
wound healing and improve scar appearance. The amino acid sequence of SLI-F06 is derived from 
an endogenous human protein that has been shown in animal models to promote accelerated wound 
healing, reduced scarring, and increased wound tensile strength. In these same animal models, the 
SLI-F06 has been demonstrated to retain similar pro-migration, pro-tensile strength, and anti-
fibrotic properties as the endogenous protein. 
SLI-F06 drug product (DP) is a sterile lyophilized powder consisting of SLI-F06 as the active 
ingredient and formulation buffer components. The DP will be reconstituted in clinic with USP 
Water for Injection and injected intradermally along both edges of a freshly made excision to 
achieve a primarily local effect.  
The route of administration, dosage, dosage regimen and treatment period for the current study are 
based on large and small animal safety and efficacy studies. Pre-clinical toxicology testing of SLI-
F06 includes a 5-day intravenous repeat dosing in rats, a 3-day subcutaneous repeat dosing in pigs, 
and a 3-day intradermal repeat dosing in a wounded pig model. The intended human drug exposure 
for the current study is far below the human equivalent dose that has demonstrated to be safe in 
animals. Please see the Investigator Brochure for a summary of all preclinical studies as well as a 
list of references. 
The study population will consist of healthy patients planning to undergo elective abdominoplasty. 
During Part A of this study (i.e., Phase I Safety/Proof of Concept), each subject will receive 12, 
14, or 18 small or large excisions at 8 weeks or 12 weeks pre-abdominoplasty. Wounds treated 
with SLI-F06 or vehicle will be followed until the time of abdominoplasty when the tissue is 
harvested. At the completion of study Part A, subjects will enter study Part B where they will 
undergo the abdominoplasty, have the abdominoplasty incision treated with SLI-F06, and be 
followed for an additional 12 months. At the completion of Part B, subjects will be invited to 
participate in the study Part B Extension where the abdominoplasty scar will be monitored for an 
additional 12 months.  
This is a first-in-human study; there are currently no human experience or regulatory actions 
related to SLI-F06. The study will be conducted in compliance with the protocol, Good Clinical 
Practices, and all applicable regulatory requirements. 
Please see the Investigator Brochure for additional information as well as a list of references. 
 
 
 
 
 


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2 
STUDY OBJECTIVES 
The primary objectives of this study are the following: 
• Part A: Assess the safety and tolerability of SLI-F06 in the treatment of planned surgical 
excisions. 
• Part B: Assess the safety and tolerability of SLI-F06 in the treatment of abdominoplasty 
incisions. 
• Part B Extension: Assess the efficacy of SLI-F06 treatment on the appearance of 
abdominoplasty incision scars. 
Secondary objectives include, but are not limited to, the following: 
• Part A: 
- 
Assess the effect of SLI-F06 on scar appearance. 
- 
Assess the effect of SLI-F06 on wound strength. 
- 
Assess the effect of SLI-F06 on histological appearance of scars. 
- 
Assess immunogenicity effects of SLI-F06. 
• Part B: 
- 
Assess the effect of SLI-F06 on post-operative abdominoplasty scar appearance. 
- 
Assess immunogenicity effects of SLI-F06. 
• Part B Extension: 
- 
None  
 


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3 
COMPLIANCE STATEMENT 
The study will be conducted in accordance with the protocol, International Conference on 
Harmonization (ICH) and Good Clinical Practice (GCP), the Declaration of Helsinki, United 
States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 21 
CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312). 
The sites’ Principal Investigator (PI) is responsible for ensuring the privacy, safety and welfare of 
the subjects during and after the study and must ensure that site personnel are appropriately trained. 
The PI must be familiar with the background and requirements of the study and with the properties 
of the IP as described in the Investigator Brochure. The PI at each site has the overall responsibility 
for the conduct and administration of the study at their site, and for contact with study site 
management, and local authorities.  
3.1 
Variations to the Protocol 
No changes from the final approved (signed) protocol will be initiated without the prior approval 
by the IRB except 1) when necessary to eliminate immediate hazards to the subjects or when the 
change involves only logistics or administration, or 2) minor administrative or typographical 
corrections. The sites’ PIs and the Sponsor must sign any protocol amendments. 
3.2 
Investigational Sites 
Up to four (4) U.S. investigational sites will participate in this study. Each site must obtain written 
approval from a 21 CFR 56 compliant IRB prior to recruitment and enrollment of any subject into 
the study. Any changes to the study procedures must be made with the mutual agreement of the PI 
and the Sponsor, documented in an amendment to the protocol, and approved by the reviewing 
IRB.  
3.3 
Medical Monitor 
A Medical Monitor will provide safety oversight for this clinical study. The Medical Monitor will 
review and evaluate SAEs upon receipt to ensure adherence to the FDA requirements for expedited 
reporting. Additionally, in consultation with the Sponsor’s team, the Medical Monitor will review 
and evaluate all AEs approximately monthly, review safety reports, and will provide consultation 
and 
recommendations 
with 
regard 
to 
inclusion/exclusion 
criteria, 
concomitant 
medications/treatments, and subject discontinuations. 


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4 
OVERVIEW OF STUDY DESIGN 
4.1 
Study Design 
This is a multicenter, double-blind study comparing SLI-F06 to vehicle formulation buffer for the 
improvement in scar appearance and wound strength in routine surgical excisions, as well as post-
operative abdominoplasty scar appearance.  Each subject will serve as his or her own control. 
Subjects desiring abdominoplasty and who consent to participate in the study will have their 
abdominoplasty site allocated and mapped into sections for standardized 3 cm length excisions 
(see Section 6.5). Number of excisions will be determined by pannus size (i.e., 12 excision sites 
for small pannus, 14 excision sites for medium pannus, 18 excision sites for large pannus). 
All excisions to be treated with SLI-F06 will be on one side of the mapped area (i.e., left side or 
right side) and vehicle treated excisions will be on the other side of the mapped area. A 
randomization scheme will assign treatment for the left and right side of the pannus. Each excision 
site will be treated post-operatively in precisely the same manner.  
Duration of follow-up will not be subject to randomization. Subjects will be allocated to 2 groups 
with different durations of post-excision follow-up (i.e., 12 weeks or 8 weeks pre-abdominoplasty) 
according to when they were enrolled into the study.  
Following completion of the designated post-excision follow-up period, the entire abdominoplasty 
site will be harvested and sent for analyses of histopathology and tensile strength. 
Subjects will then be randomly assigned to receive injections of SLI-F06 along one half (left or 
right) of the abdominoplasty incision and control injections along the other half. Injections will be 
on both sides of the incision. Subjects will undergo routine wound care and will attend study 
follow-up visits following abdominoplasty at Months 1, 2, 3, 6, 9, and 12. The entire incision will 
be treated post-operatively in precisely the same manner. 
Subjects will then be invited to participate in an observational extension of the study, Part B 
Extension. Numbering and timing of study visits will be extended from Visit 8b (M12) of Part B. 
The subject will attend study visits at Months 15, 18, 21 and 24 where they will undergo POSAS 
assessments (PI and Subject) and abdominal photography. No further treatments will be 
administered during this observational extension of the study. 
4.2 
Study Design Rationale 
4.2.1 
Study Population 
Up to 25 healthy adult subjects presenting for abdominoplasty surgery will be enrolled and 
randomized. This will include a subset of up to 6 subjects with a history of hypertrophic or keloidal 
scarring. The full description of the inclusion and exclusion criteria is found in Section 5. 
4.2.2 
Primary Effectiveness Outcome Measurements 
The primary efficacy outcome parameter will be the difference in Patient and Observer Scar 
Assessment Scale (POSAS) scores, as assessed by the PI:  
1) Between SLI-F06 treated excision sites and the vehicle treated excision sites at each 
timepoint during the Part A of the study; 
2) Between the half of the abdominoplasty incision treated with SLI-F06 and the half of the 
incision treated with vehicle during Part B and Part B Extension of the study. 


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5 
STUDY POPULATION 
5.1 
Inclusion Criteria  
5.1.1 
Part A and Part B 
The inclusion criteria below are only applicable to Parts A and B. Refer to Section 5.1.2 for the 
Inclusion Criteria for Part B Extension. 
1. Outpatient, male or female of any race, 18 years of age or older. Female subjects of 
childbearing potential must have a negative UPT at Visit 1a (Study Part A) and 1b (Study 
Part B) and practice a reliable method of contraception throughout the study. 
A female is considered of childbearing potential unless she is: 
− 
postmenopausal for at least 12 months prior to study treatment administration; 
− 
without a uterus and/or both ovaries; or 
− 
has been surgically sterile for at least 6 months prior to study treatment administration.  
Reliable methods of contraception are: 
− 
hormonal methods or intrauterine device in use >90 days prior to study treatment administration; 
− 
barrier methods plus spermicide in use at least 14 days prior to study treatment administration; or 
− 
vasectomized partner.  
[Exception: Females of childbearing potential who are not sexually active are not required to practice 
contraception. These subjects may be enrolled at the site’s PI’s discretion if they are counseled to remain 
sexually inactive during the study or agree to use an approved method of contraception should they become 
sexually active and understand the possible risks in getting pregnant during the study.] 
2. Seeking or scheduled for standard elective abdominoplasty. 
3. Willing to undergo directed excisions and follow-up prior to abdominoplasty and to 
undergo all follow-up visits after abdominoplasty. 
4. Willing to undergo directed excisions under local anesthetic (i.e., does not require general 
anesthetic). 
5. Be able to follow study instructions and likely to complete all required visits. 
6. Sign the IRB-approved ICF (which includes the Photographic Release Form and HIPAA) 
prior to any study-related procedures being performed. 
5.1.2 
Part B Extension: 
The inclusion criteria below are only applicable to Part B Extension. 
1. Current or previous participant in Part B of Study SLI-C40-001. 
2. Sign the IRB-approved ICF (which includes the Photographic Release Form and HIPAA) 
prior to any study-related procedures being performed. 
5.2 
Exclusion Criteria 
5.2.1 
Parts A and B  
The Exclusion Criteria below are only applicable to Parts A and B. Refer to Section 5.2.2 for 
the Exclusion Criteria for Part B Extension. 


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1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not 
practicing reliable birth control (as specified in Section 5.1). 
2. Known hypersensitivity or previous allergic reaction to any constituent of the IP (i.e., SLI-
F06). 
3. History of diabetes mellitus or an HgB A1C greater than 5.7 percent. 
4. Morbid obesity (i.e., BMI >40). 
5. History of prior abdominal surgery. [Note: laparoscopic surgery that did not result in open 
laparotomy or routine cesarean section surgery is acceptable provided the procedure 
occurred at least 3 years prior to Visit 1a] 
6. History of abdominal liposuction, cryolipolysis, focused ultrasound or other fat reduction 
procedures in or near the anterior abdomen within 12 months of Visit 2a. 
7. History of poor or delayed wound healing such as a prior wound dehiscence, chronic wound 
or leg ulcer. 
8. History of or evidence of a genetic collagen disorder such as Ehlers-Danlos syndrome. 
9. Operating Physician unable to design an abdominoplasty incision area of at least 25 cm 
wide by 12 cm tall at the center of the fusiform. 
10. The presence of any abnormality of the skin within the area of the proposed 
abdominoplasty that, in the opinion of the PI, could interfere with the excision process or 
grading of the resultant surgical scar (e.g., striae gravidarum, striae distensae, excessive 
nevi, numerous seborrheic keratoses, tattoos, etc.). 
11. Use of any concomitant medications/procedures or tobacco/inhaled nicotine products 
specified in Section 6.7.1 within a restricted time period. 
12. Allergy to or intolerance of local anesthetics. 
13. Medical or psychiatric conditions that may increase the risk associated with study 
participation or may interfere with interpretation of study results or compliance of the 
subject and, in the opinion of the PI, would make the subject inappropriate for study entry. 
14. Any personal, familial, employment or financial situation that could impede the subject’s 
ability to attend all study visits and successfully complete the entire clinical study. 
15. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. 
16. Exposure to any other investigational drug/device within 30 days prior to study entry. 
5.2.2 
Part B Extension  
The Exclusion Criteria below are only applicable to Parts B Extension. 
1. None 
5.3 
Subject Withdrawal Criteria 
Reasons for withdrawal may include, but are not limited to, the following: 
• At the request of the PI or study Sponsor (e.g., for tolerability reasons, SAE, etc.). 
• At the request of the subject. 
• When the requirements of the protocol are not followed. 


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• When a concomitant therapy or interventional surgery required by the subject is likely to 
interfere with study results, (report all such information on the source documents and CRFs) 
and confer with the Sponsor if the subject should be withdrawn). 
• When a subject is lost to follow-up. The PIs will try at least twice to reach the subject by 
telephone and document these attempts and then send a follow-up letter by certified mail 
before considering that the subject is lost to follow-up. 
All premature discontinuations and their reasons must be carefully documented by the PI in the 
source documents, CRF, and (if applicable), on the AE form. 
No subject who has received study injection(s) can be replaced if they discontinue prematurely for 
whatever reason. All data gathered on the subject prior to termination will be made available to 
the Sponsor. 
Reasons for study completion/discontinuation as listed on the final report form are defined as 
follows: 
• Normal Study Completion – Subject completes the study as planned in the protocol. 
• Adverse Event – Complete AE form. 
• Death – Complete SAE form. 
• Subject Request – Consent withdrawal, subject moved, schedule conflicts. 
• Protocol Violation – Contact the Sponsor or designee before making decision. 
• Lost to Follow-Up – Document with 2 phone calls and a certified letter. 
• Pregnancy – Subject will discontinue study drug immediately, but will be followed to term. 
Complete pregnancy form. 
• Study Terminated by Sponsor  
• Other – Specify in comments section of final CRF. 
Subjects are free to withdraw from participating in this study at any time and for whatever reason, 
specified or unspecified, and without prejudice. 
 


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6 
TREATMENT PLAN 
6.1 
Subject Numbering 
Each screened subject will be assigned a unique 4-digit study subject number assigned by the 
investigational site, which will consist of a pre-assigned 1-digit investigational site number and a 
3-digit chronological screening order number, starting with 001 (e.g., 1001, 1002). Subject 
Numbers will not be omitted or reused. Subjects withdrawn from the study will retain their Subject 
Number; new subjects will be allotted a new Subject Number. 
6.2 
Randomization 
A hardcopy computer generated “Randomization Schedules” will link a bilateral (left, right) 
treatment assignment to each Subject Number (Section 6.1). Randomization to treatment 
assignment for Part A will be independent of Part B randomization. The Randomization Schedule 
will be maintained by the Independent Drug Reconstitutor (Section 6.3). During Part A, all 
excisions to be treated with SLI-F06 for a given subject will be on one side of the mapped area 
(i.e., left side or right side) and vehicle treated excisions will be on the other side of the mapped 
area. During Part B, one side of the abdominoplasty incision will be treated with SLI-F06 (i.e., left 
side or right side) and the other side of the incision will be treated with vehicle. 
6.3 
Blinding 
To maintain study blind, the Independent Drug Reconstitutor (IDR) (i.e., pharmacist, study nurse 
or physician not responsible for subject follow-up) will have access to the Randomization Schedule, 
be aware of treatment assignment, and will prepare study medication. “Injectors”, Investigators, 
and study coordinators responsible for subject assessment and follow-up, and study subjects will 
remain unaware of which study treatment was injected on either side of the pannus or 
abdominoplasty incision, but might not be blinded to the degree of wound tension. 
The IDR will consult the Randomization Schedule, prepare syringes of SLI-F06 and vehicle, and 
label syringes accordingly with the designation of “left side” or “right side”. 
6.4 
Unblinding 
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study (or for interim analyses). Specifically, the blind will be broken only after all data are 
verified, entered into the database and validated, and the database is locked. If it is medically 
imperative to know what study treatment was injected on a particular side, the Investigator or 
authorized person will contact the IDR (or designee) to obtain the treatment assignment for that 
subject. Prior to unblinding, the investigator should attempt to contact the Medical Monitor and 
ethica CRO Inc. to discuss the rationale for unblinding. The rationale for breaking the code must 
be recorded in the subjects’ medical record and eCRF. 
6.5 
Pannus Excision Sites - Study Part A 
6.5.1 
Excision Sites 
Each excision site will be a 3 cm long fusiform excision. All excisions will be performed in an 
identical manner except for dimensions. Two types of fusiform excisions will be made (templates 
will be provided): 
• Low tension wounds will have a 3 cm length with a maximum midpoint width of 1 cm; 
• High-tension wounds will have a 3 cm length and a maximum midpoint width of 2 cm.  


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6.5.2 
Pannus Map and Excision Template 
The Investigator will assess the subject’s abdomen (while supine) and will select the appropriate 
size of pannus map. If unable to select a suitable pannus map, the subject will be considered as a 
screen failure. The following sizes of pannus maps will be supplied to the site: 
Small pannus map:  For an abdominoplasty area of at least 25 cm length x 12 cm height. This 
map accommodates 6 small wounds (3 cm length x 1 cm width, green wounds) and 6 large wounds 
(3 cm length x 2 cm width, blue wounds) for a total of 12 wounds per subject. The excision sites 
will be numbered as shown in Figure 1 below: 
 
Figure 1. Small Pannus Map 
Medium pannus map: For an abdominoplasty area of at least 30 cm length x 14 cm height. This 
map accommodates 6 small wounds (3 cm length x 1 cm width, green wounds) and 8 large wounds 
(3 cm length x 2 cm width, blue wounds) for a total of 14 wounds per subject. The excision sites 
will be numbered as shown in Figure 2 below: 
 
Figure 2. Medium Pannus Map 


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Large pannus map: For an abdominoplasty area of at least 32 cm length x 18 cm height. This 
map accommodates 8 small wounds (3 cm length x 1 cm width, green wounds) and 10 large 
wounds (3 cm length x 2 cm width, blue wounds) for a total of 18 wounds per subject. The excision 
sites will be numbered as shown in Figure 3 below: 
 
Figure 3. Large Pannus Map 
6.5.3 
Excision Site Mapping 
The PI will designate the excision sites with the subject in the supine position and using the 
selected pannus map. 
Pannus maps will have pre-punched holes at the center of each fusiform. With the subject in a 
supine position, the PI will place the map over the pannus and, using permanent ink, will place a 
“dot” on the skin through each hole, thus indicating the center of each planned excision. 
Two sterilizable ink stamps will be provided to each investigative site. One stamp will trace the 
fusiform for high-tension excision sites, and the other stamp will trace the fusiform for low-tension 
excision sites. Referring to the pannus map, the OP will select the appropriate “excision stamp” 
(i.e., high vs. low tension as per R1, L1, R2, etc.), place the stamp over the previously marked dot, 
and apply a tracing outlining the fusiform to be excised. Each tracing will be orientated 
horizontally, as per the pannus map. 
 
 


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6.5.4 
Sequence of Excisions 
Bilateral matched excisions (e.g., R1/L1, R2/L2, etc.) are to be performed in sequence. Each 
individual excision should be injected and then closed prior to performing the next excision (i.e., 
do not perform all of the excisions, followed by all of the closures). Injection of study drug is to 
be performed before closure (i.e., excise skin, undermine if needed, hemostasis, inject study drug, 
then skin closure). 
It is acknowledged that during the excision process, the topography of the pannus will change and 
the final placement, orientation, and number of excisions may not match pre-defined pannus 
mapping. In such cases, the abdominoplasty map should be updated and annotated accordingly in 
order to match the final placement, orientation, and number of excisions. 
6.5.5 
Pre-operative Preparation and Patient Monitoring 
Prophylactic antibiotics are allowed on a case-by-case basis, at the discretion of the Investigator. 
Use of sedative/pain medication (e.g., 10mg diazepam, hydrocodone with acetaminophen, etc.) or 
nitrous oxide is allowed on a case-by-case basis to relieve anesthetic injection pain and anxiety, at 
the discretion of the Investigator. Routine patient monitoring (e.g., BP, HR, oxygen saturation, 
etc.) is to be conducted at the discretion of the Investigator. 
6.5.6 
Anesthetic Preparation and Administration 
At each excision site, local injections of dilute anesthetic solution with epinephrine should be used 
as per the site’s standard practice (e.g., 0.05-0.1% lidocaine with ~1:1,000,000 epinephrine) with 
or without sodium bicarbonate. Use of dilute anesthetic solutions containing epinephrine is 
suggested in order to optimize hemostasis. Total lidocaine dosage should not exceed established 
lidocaine guidelines of 7 mg/kg with respect to mg lidocaine per kg patient weight. Use of 1% 
rather than 2% is suggested to minimize over-dosing errors. 
6.5.7 
Excision Procedures 
A #15 scalpel will be used to excise the skin up to the subcutaneous fat (minimize fat removal). 
As the intent of this study is to test scar formation in wounds closed under tension, undermining 
of wound edges should be avoided if possible. If undermining is required, the surgeon will use 
only the minimal amount needed to close the wound and will undermine at the level of the 
subcutaneous fat about 1 cm deep to the dermis (avoid undermining more than 1 cm horizontally 
from the cut wound edge if possible). The use of undermining will be recorded in the CRF. 
Hemostasis should be achieved by light pressure, topical epinephrine (1:100,000 dilution on Telfa 
strips), or additional injection of the dilute anesthetic solution only. Electrocautery will be avoided 
if possible. At this point, study treatment will be injected (i.e., after excision, potential 
undermining, and hemostasis, but before wound closure). See Section 6.5.8 below. 
As per Figure 4 below, the deep dermal and subcutaneous layers will be closed using 2 equally 
spaced #4-0 poliglycaprone 25 (e.g., Monocryl) simple, buried, deep dermal interrupted sutures 
(the knot should be closer to the subcutaneous fat, deep to the deep dermis). The 3 cm wound will 
be divided into thirds (i.e., each third will be 1 cm). Sutures will be placed at the 1 cm and 2 cm 
locations in the wound while avoiding any sutures in the middle cm of the 3 cm long wound). 
The skin edge will be closed with 4 equally (approximate) spaced #5-0 polypropylene (e.g., 
Prolene) simple interrupted sutures that are approximately 4 mm from the skin edge and effectively 
evert the skin edge.  Ensure that a 0.6 cm suture-free area remains at the midpoint of the wound 


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and note gap size in mm in the center of the wound after all sutures are placed (i.e., “0 mm” 
indicates no gap). 
 
 
6.5.8 
Administration of Investigational Product (Excisions) 
Excisions are to be injected on each edge of the wound, immediately prior to closure, using a 29G 
needle. The solution of SLI-F06 or vehicle solution will be injected intradermally into BOTH 
edges of the surgical wound immediately prior to closure. The concentration of SLI-F06 will be 
25 mg/ml. 
The needle should be inserted into the dermis, and while keeping parallel to both the dermis and 
the wound edge, the needle will be advanced 0.75 cm. 
A total of 0.4 mL (10 mg) will be injected at each excision site. A total of 0.2 mL (5 mg) will be 
injected along EACH SIDE of the wound edge. As each wound edge is 3 cm in length, 0.05 mL 
will be injected per 0.75 cm of wound edge). 
Investigational Product will be injected into the dermis while the needle is withdrawn (avoiding 
injection into the subcutaneous fat). Care should be taken to avoid ‘bare areas” along the wound 
edge where no study treatment is injected (i.e., the needle should always slightly advance into the 
area of the previous needle insertion). 
6.5.9 
Wound Care (Excisions) 
A sterile dressing of non-stick gauze (i.e., Telfa or similar) and paper surgical tape will be applied 
along with  ~1 gram of petrolatum ointment. Wounds may be individually dressed, or all dressed 
together (Investigator preference). 
Extreme care will be taken to ensure the uniform application of post-operative care to each excision 
site. Subjects will be instructed to apply new bandages once per day after bathing/showering. Each 
excision site will have sutures removed at the next clinic visit (nominally in 8 days). 
Upon suture removal, use of adhesive strips is prohibited. The CRF will capture any use of 
adhesive strips and any such use will be treated as a protocol violation. 
Figure 4. Suture Placement for Excision Closure  
- Avoid placing suture material in the middle of the wound. 
- Divide the deep dermal layer into thirds and place 2 absorbable (e.g., Vicryl) sutures. 
- Divide the outer skin layer into fifths and place 4 non-absorbable sutures. 


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6.6 
Abdominoplasty Incision – Study Part B 
6.6.1 
Surgical Preparation and Patient Monitoring 
Surgical preparation and patient monitoring during surgery will be performed according to the 
surgeons’ standard practice and best medical judgment on a per-patient basis. 
6.6.2 
Surgical Anesthesia 
Surgical anesthesia will be administered according to the surgeons’ standard practice and best 
medical judgment on a per-patient basis. 
6.6.3 
Abdominoplasty Surgery 
Prior to handing off the pannus specimen, the orientation of the pannus will be confirmed by 
placing a simple, non-absorbable suture in the top midline (leaving a short tail of ~1 cm) and a 
simple non-absorbable suture on the patient’s left corner of the pannus (leaving a long tail ~5-10 
cm). 
Abdominoplasty will be performed according to the surgeons’ standard practice and best medical 
judgment on a per-patient basis. 
Closure of the abdominoplasty incision will be performed according to the surgeons’ standard 
practice and best medical judgment on a per-patient basis. 
Study treatment will be injected immediately after incision closure. 
6.6.4 
Administration of Investigational Product (Abdominoplasty) 
On the upper and lower wound edges and using a surgical marker, a line will be drawn at the exact 
center of the abdominoplasty incision, separating the left from the right side. The randomization 
code will dictate which study treatment will be injected into the left and right sides of the incision. 
Using a 29G needle, each edge of the incision wound is to be injected immediately after closure. 
The needle should be inserted into the dermis. Injections should run parallel and 1 mm from the 
incisional line. Injections will start 1 cm from the mid-point on each side of both wound edges and 
will proceed laterally. While keeping parallel to both the dermis and the wound edge, the needle 
will be advanced 0.75 cm and a total volume of 0.05 ml of study treatment for each 0.75 cm of 
wound edge will be injected into the dermis while the needle is withdrawn back to the injection 
point (avoiding injection into the subcutaneous fat).  Injections will be repeated in the same manner 
until the entire length of the wound edge (i.e., left or right side, as per the randomization schedule) 
has been injected. Care should be taken to avoid ‘bare areas” (except for the 2 cm area at the mid-
point) along the incision line where no study treatment is injected (i.e., the needle should always 
advance slightly into the area of the previous needle insertion) (see Fig. 5). 


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Figure 5. Injection of the abdominoplasty incision 
 
6.6.5 
Wound Care (Abdominoplasty) 
Post-surgical wound care will be administered according to the surgeons’ standard practice and 
best medical judgment on a per-patient basis. Care must be taken to ensure the uniform application 
of post-operative care to the entire incision area. 
The timing of suture removal, if applicable, is at the discretion of the Investigator as per the 
Investigator’s standard of care. Sutures will be removed as per the Investigator’s standard of care, 
and with appropriate consideration for the suturing method employed (e.g., subcuticular, 
absorbable vs. non-absorbable sutures, use of DERMABOND, etc.).  
Upon suture removal, if applicable, the use of adhesive strips will be recorded in the CRF. If 
adhesive strips are used, all efforts should be made to ensure identical use of strips on the left and 
right side of the incision. The use of adhesive strips will be recorded in the CRF. 
6.7 
Observational Extension - Part B Extension 
6.7.1 
Participant Recruitment  
Ongoing subjects and subjects who exited Part B of the study will be asked to join the Part B 
extension. A new informed consent form will be signed.  
6.8 
Concomitant Medications and Procedures 
For Study Parts A and B, any medication or procedure, including over-the-counter preparations, 
that the subject takes during the study protocol period is considered concomitant medication and 
will be captured on the Concomitant Medications page of the eCRF. 
Every attempt should be made to keep concomitant therapy dosing constant during the study. Any 
change to concomitant therapy should be noted in source documents and the eCRF. 
For Study Part B Extension, no concomitant medication will be recorded in the eCRF or source 
documents unless it is needed to treat a Treatment Related AE. 
6.8.1 
Prohibited Treatment and Procedures 
Necessary therapies that will not interfere with the response to treatment or interpretation of results 


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may be provided to the subject at the discretion of the PI. 
As per Table 1 below, the following medications are prohibited during the course of the study and 
appropriate washout periods noted below (calculated from Visit 2a) must be respected: 
 
Table 1.  Prohibited medications and procedures 
Description 
Washout Period 
• 
Systemic corticosteroids (e.g., prednisone, triamcinolone, etc.)  [NOTE: inhaled and 
insufflated corticosteroids of stable dosing are acceptable] 
4 weeks 
• 
Topical corticosteroids in or around the treatment areas [NOTE: low/medium potency 
corticosteroids may be used in areas removed from the treatment area with caution to ensure no 
contamination of the treatment area] 
4 weeks 
• 
Antimetabolite medications (e.g., methotrexate, azathioprine, 6-mercaptopurine, etc.)  
8 weeks 
• 
Antineoplastic agents  
4 weeks 
• 
Chronic NSAID use (i.e., use for more than 7 days out of the prior 14 days)  [NOTE: 
short courses of NSAIDS are allowable to manage acute pain/inflammation syndromes but should be limited 
to 7 days or less] 
4 weeks 
• 
Oral hypoglycemic agents or any form of insulin 
2 years 
• 
Agents that prolong bleeding times (i.e., coumarin, heparin, clopidogrel, Factor Xa 
inhibitors, vitamin E supplementation ≥30,000 IU per day, etc.) 
4 weeks 
• 
Investigational drug or device 
30 days 
• 
Tobacco/inhaled nicotine products (cigarettes, pipe, snuff, cigars, vaporizers) 
6 months 
• 
Incisional surgery of any kind from the level of the umbilicus to the knees 
12 months 
• 
Any cosmetic surgery (e.g., facelift, breast enhancement, etc.). 
Prohibited during 
study Parts A and B 
(Not applicable to 
Part B Extension) 
 
All treatment/procedures received by the subject within 30 days prior to Visit 1a and throughout 
the treatment period, including the name of the treatment/procedure, must be recorded in the eCRF 
with end dates, if applicable. Use of prohibited treatment/procedures must be recorded in the eCRF 
up to the extent of the prohibited time period indicated above. 
In the event such prohibited therapies are administered during the study period, the Medical 
Monitor will be contacted to discuss the details of the event. Subject participation will not 
automatically be discontinued. At a minimum, the event will be documented by the site staff as a 
protocol deviation, as instructed by the Medical Monitor. Depending upon the nature of the 
prohibited therapy and the timing relative to the determination of the primary endpoint, the 
Medical Monitor may make a decision to discontinue the subject. 
The decision to administer a prohibited medication/treatment is done with the safety of the study 
participant as the primary consideration. If the permissibility of a specific medication/treatment is 
in question, the Medical Monitor should be contacted before the prohibited medication/treatment 
is administered. 


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7 
STUDY DRUG MATERIALS AND MANAGEMENT 
7.1 
SLI-F06 (Investigational Product) 
SLI-F06 drug product will be provided by the Sponsor as a lyophilized powder. It consists of SLI-
F06 and the formulation buffer components in a lyophilized cake. It will be reconstituted with USP 
Water for Injection just prior to use.  
7.2 
Formulation Buffer 
Formulation buffer will be provided as a lyophilized powder consisting of L-histidine, disodium 
phosphate, D-mannitol, and deionized water. Adjusted to pH 6.5 with NaOH or HCl as required. 
It will be reconstituted with USP Water for Injection just prior to use. 
7.3 
Packaging and Labeling 
Product supplies will be packaged in glass vials with labeling for storage conditions. 
7.4 
Storage, Handling, and Disposal of Investigational Product 
Upon receipt of the study drug, the PI is responsible for ensuring that the designated staff member 
will conduct a complete inventory of study materials and assumes responsibility for their storage, 
dispensing and disposal. In accordance with federal regulations, the PIs must keep all study 
materials in a secure location with restricted access. The PI will keep a record of the inventory and 
dispensing of all study drugs. All supplies sent to the PIs will be accounted for and, in no case, 
used in any unauthorized situation. 
Lyophilized SLI-F06 and lyophilized formulation buffer will be stored at -20oC (-25°C to -15°C). 
Lyophilized formulation buffer will be brought to room temperature (20°C to 25°C) and 
reconstituted with USP Water for Injection. Reconstitute each vial with 1mL USP Water for 
Injection to create a 25mg/mL solution and, then store on ice or keep in the refrigerator at 4°C 
(refrigerated reconstituted product or product on ice must be used within 8 hours). Note that one 
vial will be sufficient to load 2 syringes or treat 2 wounds (Part A). For the abdominoplasty (Part 
B, one vial will be sufficient to treat approximately 15 cm of a single wound edge. 
All used and unused supplies will be returned to Sponsor/designee for destruction at the conclusion 
of the study. 
7.5 
Dosing and Administration 
SLI-F06 will be supplied as a lyophilized powder (25 mg/vial) and will be diluted with 1 ml USP 
Water for Injection to make a 25 mg/ml solution. Formulation buffer (25 mg of lyophilized powder 
per vial) will be diluted with 1 ml USP Water for Injection to make a 25 mg/ml solution.  
Immediately prior to closure, excisions will be injected along BOTH wound edges at 0.05 mL per 
0.75 cm of single wound edge. The total dose of SLI-F06 for each subject is based on the number 
of excisions and abdominoplasty incision length. Total dose exposure follows: 
  Part A: 
 
• 90 mg of SLI-F06 (9 treated excisions) for subjects with large pannus 
• 70 mg of SLI-F06 (7 treated excisions) for subjects with smaller pannus 
• 60 mg of SLI-F06 (6 treated excisions) for subjects with smaller pannus 
  Part B: 
 
• 41.7 mg of SLI-F06 for subjects with a 25 cm wound (12.5 cm active treatment) 
• 50.0 mg of SLI-F06 for subjects with a 30 cm wound (15 cm active treatment) 
• 53.3 mg of SLI-F06 for subjects with a 32 cm wound (16 cm active treatment) 
Part B Extension: 
• There will be no exposure to SLI-F06 or vehicle solution. 


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8 
DATA COLLECTION 
8.1 
Electronic Case Report Form 
Treatment and follow-up of subjects will be recorded in a 21 CFR part 11 compliant eCRF. Data 
will be first recorded into the medical record and study specific source document worksheets prior 
to entry into the eCRF. 
8.2 
Laboratory Data 
Laboratories utilized in this study (clinical safety, immunogenicity, tensile strength, and histology) 
will provide electronic data transfers that will be maintained separate from the eCRF. 
8.3 
Photography 
Photographs of treatment areas will be taken according to a standardized protocol incorporating 
appropriate quality control processes. A reshoot may be requested if quality standards are not met. 


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9 
STUDY EVALUATIONS 
9.1 
Informed Consent 
The PI (or designate) will explain the benefits and risks of participation in the study to each subject 
and will obtain written informed consent. Written informed consent must be obtained prior to the 
subject entering the study (before initiation of any study related procedure). 
9.2 
Study Part A 
9.2.1 
Visit 1a (Screening Period; Day -30 to 0)  
• Written informed consent 
• Inclusion / exclusion criteria for Part A and Part B  
• Medical history and demographics 
• Physical exam 
• UPT (if female subject of childbearing potential) 
• Concomitant medications/treatments 
• Abdominoplasty area assessment and selection of pannus map size 
• Immunogenicity sampling 
• Safety laboratory sampling 
• Concomitant medications/treatments 
9.2.2 
Visit 2a (Abdominal Excisions; Day 1) 
• UPT (if female of childbearing potential and if last UPT was >7 days before V2a) 
• Randomization 
• Excisions 
• IP Injection 
• Abdominal area photography (pre- and post-excisions) 
• Adverse events assessment 
• Concomitant medications/treatments 
9.2.3 
Visit 3a (Suture Removal; Day 8; ±1 day) 
• Immunogenicity sampling 
• Abdominal area photography 
• Suture removal 
• POSAS grading (post-suture removal) 
• Adverse events assessment 
• Concomitant medications/treatments 
9.2.4 
Visit 4a (Day 29; ±2 days) 
• Immunogenicity sampling 
• Safety laboratory sampling 
• Abdominal area photography 
• POSAS grading 
• Concomitant medications/treatments 
• Adverse events assessment 


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9.2.5 
Visit 5a (Day 57; ±3 days) 
• Immunogenicity sampling 
• Safety laboratory sampling (Group 2 only) 
• Abdominal area photography 
• POSAS grading  
• Concomitant medications/treatments 
• Adverse events assessment 
• Group 2 subjects enter Study Part B 
9.2.6 
Visit 6a (Day 85; ±3 days) 
• Immunogenicity sampling 
• Safety laboratory sampling (Group 1 only) 
• Abdominal area photography 
• POSAS grading  
• Concomitant medications/treatments 
• Adverse events assessment 
• Group 1 subjects enter Study Part B 
9.3 
Study Part B 
9.3.1 
Visit 1b (Day 0; Abdominoplasty) 
• UPT (prior to abdominoplasty, if female subject of childbearing potential) 
• Abdominoplasty/tissue harvesting* 
• Randomization 
• IP injections 
• Concomitant medications/treatments 
• 
Adverse events assessment 
* the abdominoplasty will be performed according to the surgeons’ standard practice and best medical 
judgment on a per-patient basis 
9.3.2 
Visit 2b (Day 8; ±1 day) 
• Immunogenicity sampling  
• Concomitant medications/treatments 
• Adverse events assessment 
9.3.3 
Suture Removal Visit (Timing of visit at the discretion of the Investigator) 
• Suture Removal  
• Concomitant medications/treatments 
• Adverse events assessment 
9.3.4 
Visit 3b (Month 1 ± 3d) 
• Immunogenicity sampling  
• Safety Laboratory Testing 
• Abdominal area photography 
• POSAS grading 
• Concomitant medications/treatments 
• Adverse events assessment 


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9.3.5 
Visit 4b, 5b, 6b, and 7b (Month 2 ± 7d, Months 3, 6, and 9 ± 14d) 
• UPT (if female subject of childbearing potential; except for V4b) 
• Immunogenicity sampling  
• Abdominal area photography* 
* If photographs do not meet the Sponsor and/or Photography vendor quality 
standards, participants will be asked to return to the study site for a reshoot (except 
for V4b). 
• POSAS grading 
• Concomitant medications/treatments 
• Adverse events assessment 
9.3.6 
Visit 8b (Months 12 ± 14d) 
• UPT (if female subject of childbearing potential) 
• Immunogenicity sampling 
• Safety Laboratory Testing 
• Abdominal area photography* 
* If photographs do not meet the Sponsor and/or Photography vendor quality 
standards, participants will be asked to return to the study site for a reshoot (except 
for V4b). 
• POSAS grading 
• Concomitant medications/treatments 
• Adverse events assessment 
• Study Exit 
Subject does not consent to Part B extension 
- 
If a photography reshoot IS NOT required, Study Exit date will be the date the 
V8b photography report is received.  
- 
If one or more photography reshoots ARE required, Study Exit date will be the 
date on which the last reshoot photography report is received or the date the 
participant decline additional photography session. 
Subject consent to Part B extension 
- 
Participant will be exited from Part B. 
- 
Subject will enter Part B Extension. 
9.4 
Study Part B Extension 
A subject first visit in Part B extension may be conducted at an alternative timepoint than Visit 9b 
and a scheduled visit may be cancelled as per the directive of the Sponsor.  
9.4.1 
Visit 9b, 10b, and 11b (Months 15, 18, 21 ± 14d) 
• Written Informed Consent* 
• Inclusion/ exclusion criteria Part B extension**  
• Abdominal area photography 
 If photographs do not meet the Sponsor and/or Photography vendor quality 
standards, subjects will be asked to return to the study site for a reshoot. 
• POSAS grading 
• Treatment Related Adverse Events assessment 
• *To be performed during first visit of Part B Extension if consent not obtained at Visit 8b. 


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• ** To be performed during first visit of Part B Extension.  
9.4.2 
Visit 12b (Month 24 ± 14d) 
• Abdominal area photography 
 If photographs do not meet the Sponsor and/or Photography vendor quality 
standards, subjects will be asked to return to the study site for a reshoot. 
• POSAS grading 
• Treatment Related Adverse Events assessment 
9.4.3 
Study Exit 
The Final visit may be conducted at any timepoint (Month 15, 18, 21 or 24) 
• If a photography reshoot IS NOT required, Study Exit date will be the date the 
photography report is received for the last visit.  
• If one or more photography reshoots ARE required, Study Exit date will be the date on 
which the last reshoot photography report from the last visit is received or the date the 
participant decline additional photography session. 
9.4.4 
Optional Visit 
The Sponsor may request that an Optional Visit(s) be conducted at an alternative timepoint. 
• Written Informed Consent* 
• Inclusion/ exclusion criteria Part B extension**  
• Abdominal area photography 
 If photographs do not meet the Sponsor and/or Photography vendor quality 
standards, participants will be asked to return to the study site for a reshoot. 
• POSAS grading 
• Treatment Related Adverse Events assessment 
*To be performed if first visit of Part B Extension and consent not obtained at Visit 8b. 
** To be performed if first visit of Part B Extension Visit.  
9.5 
Efficacy 
9.5.1 
Primary Efficacy Variable 
9.5.1.1 
POSAS (PI Assessment) – Excisions/Abdominoplasty Incisions (Parts A, B, and B 
Extension) 
The Patient and Observer Scar Assessment Scale (POSAS; Appendix B) will be used to assess the 
various parameters of each excision site and the abdominoplasty incision. At each observation time 
point, the PI will grade each scar using the “Observer Scale” of the POSAS. The PI assessment 
will be conducted after the subject POSAS assessment so as not to influence the subject’s grading. 
9.5.2 
Secondary Efficacy Variables 
9.5.2.1 
POSAS (Subject Assessment) – Abdominoplasty Incisions (Parts B and B 
Extension) 
At each observation time point, the subject will be directed to grade the left and right side of the 
incision scar separately using the “Patient Scale” criteria of the POSAS. Then, each side of the 
abdominoplasty incision (left and right) will be divided into 5cm sections starting from the 
midpoint moving outwards to the end of the incision. The subject will use the “Patient Scale” 
criteria of the POSAS to assess the middle 3cm section within each 5cm section of the incision 


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line. Sections that are less than 5cm (as well as their paired contralateral section) will not be 
assessed (Refer to Figure 6). After the subject has completed his/her grading, the PI will grade the 
incisional scar using the “Observer Scale” of the POSAS.  
 
 
Figure 6. 5cm sections of Abdominoplasty Incision 
9.5.2.2 
POSAS (PI assessment) – Abdominoplasty 5 cm sections (Parts B and B Extension) 
Using a standard clear plastic 15 cm ruler and surgical marker, each side of the abdominoplasty 
incision (left and right) will be divided into 5cm sections starting from the midpoint moving 
outwards to the end of the incision. Markings will be placed 2 cm below the scar incision in order 
to not obstruct the scar. The PI will use the POSAS to assess the middle 3cm section within each 
5cm section of the incision line. Sections that are less than 5cm (as well as their paired contralateral 
section) will not be assessed (Refer to Figure 6). 
Photography will be taken of each individual section including those that are less than 5 cm (as 
well as their contralateral section) in order to obtain photographs of the scar terminus. A 5cm 
adhesive ruler will be adhered at least 2 cm underneath each 5 cm section in order to confirm 
accuracy of the 5cm markings. Pre- identified labels (i.e., L1, L2, L3, etc.) will be adhered directly 
above each section. 
9.5.2.3 
Independent Panel Review - Photography 
At each observation time point, close-up photographs of each excision will be taken. Upon study 
completion, a panel of raters will review the photographs in a blinded fashion. Assessors will grade 
scars using the “Observer Scale” of the POSAS (pliability and vascularity will not be assessed). 
9.5.2.4 
Histology 
Study Part A only. Histologic appearance of excision sites will be assessed and compared. 
Logistics and assay specifics will be provided in a separate manual. 
9.5.2.5 
Tensile Strength 


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Study Part A only. Ex vivo tensile strength of excision sites will be assessed and compared. 
Logistics and assay specifics will be provided in a separate manual. 
9.5.3 
Exploratory Efficacy Variables 
9.5.3.1 
POSAS (Subject Assessment) – Excisions (Part A) 
At each observation time point during study Part A, the subject will be directed to grade each 
excision scar separately using the “Patient Scale” criteria of the POSAS. After the subject has 
completed his/her grading, the PI will grade each excision scar using the “Observer Scale” of the 
POSAS. 
9.6 
Safety  
9.6.1 
Clinical Safety Laboratory Tests 
Standard clinical laboratory analyses (CBC/Diff, chemistry) will be conducted on blood samples 
collected at Screening V1a, V4a (Day 29), V5a (Day 57 - Group 2 only), V6a (Day 85 - Group 1 
only), V3b (M1) and at study exit. 
Clinically significant results, in the opinion of the PI, should be reported as AEs. If an AE requires 
laboratory testing, the results of the test must be obtained by the investigative site and filed in the 
subject’s documentation. 
9.6.2 
Immunogenicity Testing 
During Study Part A, immunogenicity analyses will be conducted on blood samples collected from 
subjects at Screening V1a, V3a (Day 8), V4a (Day 29), V5a (Day 57) and V6a (Day 85 - Group 1 
only). During Study Part B, immunogenicity analyses will be conducted at V2b (Day 8), V3b 
(M1), V4b (M2), V5b (M3), V6b (M6), V7b (M9), and V8b (12M).  
Logistics and assay specifics will be provided in a separate manual. 
9.6.3 
Adverse Events 
During Parts A and B, all observed or volunteered AEs regardless of treatment group or suspected 
causal relationship to the study treatment will be recorded in the eCRF. Subjects will be questioned 
for the occurrence of any new or worsening signs or symptoms at each visit. 
During Part B Extension, all Treatment-Related AEs (TRAEs) will be recorded in the eCRF. 
Subjects will be questioned for the occurrence of any new or worsening signs or symptoms at each 
visit. 
9.6.3.1 
Definition of Adverse Event 
An AE is any untoward medical occurrence in a patient or clinical investigation subject 
administered a medicinal product and which does not necessarily have a causal relationship with 
the study drug. AEs include any unfavorable and unintended illness, sign, symptom, clinically 
significant laboratory test abnormality, or disease temporally associated with the use of a medicinal 
product that has appeared or worsened during the course of the clinical trial, regardless of causal 
relationship to the study drug(s) under study. AEs include any illness, sign, symptom, or out-of-
range and clinically significant laboratory finding that has appeared or worsened during the course 
of the clinical trial, regardless of causal relationship to the study. Typical signs and symptoms of 
minor excisional surgery are NOT to be considered adverse events UNLESS: 
• They persist longer than expected by the investigator 
• They are more severe than expected by the investigator 


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Findings that should be considered typical of minor excisional surgery include: 
• Pain  
• Pruritus 
• Erythema 
• Bruising  
• Tenderness 
• Crusting/ Scabbing 
• Any other finding that the investigator would expect to observe in routine, uncomplicated 
minor excisional surgery  
The collection of non-serious AEs and serious adverse events (SAEs) will begin following the 
subject's exposure to SLI-F06. 
9.6.3.2 
Documenting Adverse Experiences 
During Parts A and B, the PI is responsible to document all AEs that occur during the study. AEs 
should be documented as a single medical diagnosis. When this is not possible, AEs should be 
documented in terms of signs/symptoms observed by the PI or reported by the subject at each study 
visit. Each AE that appears to be independent of any prior event will be reported separately. 
All AEs occurring after the subject first exposure to SLI-F06 through the last study visit must be 
reported, regardless of AE causality. All AEs, whether in response to a query, observed by the 
study site personnel, or reported spontaneously by the subject, will be recorded. Any clinically 
significant AEs deemed related to treatment reported or observed at the final study/treatment visit 
will be followed until stabilization or resolution (or up to 30 days after final study visit). 
At each visit during the study, the subject will be assessed for the occurrence of new and ongoing 
AEs. The following data will be collected on all AEs and recorded on the appropriate CRF: 
• Event name (diagnosis preferred, if unknown, record the signs/symptoms) 
• Onset date and end date 
• Maximum intensity (severity) 
• Seriousness 
• Action taken regarding study drug 
• Corrective treatment, if given 
• Outcome 
• PI’s assessment of causality 
Vital sign abnormalities are to be recorded as AEs only if they are clinically significant (for 
example: are symptomatic, requiring corrective treatment, leading to discontinuation or fulfilling 
a seriousness criterion). 
For findings considered typical of minor excisional surgery that persist or become more severe 
than expected, the investigator should determine: 
• The start date – when the finding exceeds what may be typically seen with minor excisional 
surgery. 
• Maximum intensity (severity) – using the definitions for adverse event severity found in 
section 9.6.3.4, the investigator should assign a severity to the adverse event. For events 
that change in severity, the maximum severity attained should be recorded. 


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• The end date – the investigator should record the date that the finding returns to a typical 
severity or duration, NOT necessarily when the finding is fully recovered. For example, a 
subject who notes pain well above what would be expected for three days after the 
procedure but has very minor pain thereafter for six additional days should have an adverse 
event of pain lasting three days, not pain lasting nine days. 
During Part B Extension, the PI is responsible to document all TRAEs that occur during the study. 
TRAEs should be documented as a single medical diagnosis. When this is not possible, TRAEs 
should be documented in terms of signs/symptoms observed by the PI or reported by the subject 
at each study visit. Each TRAE that appears to be independent of any prior event will be reported 
separately. 
9.6.3.3 
Serious Adverse Events 
All AEs will be assessed as either serious or non-serious. An SAE is defined as any untoward 
medical occurrence that at any dose: 
• Results in death 
• Is immediately life threatening, (the term "life threatening" in the definition of "serious" 
refers to an event in which the subject is 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) 
• Requires in patient hospitalization or prolongation of existing hospitalization 
(hospitalization for elective surgery for a baseline condition is not considered an AE) 
• Results in persistent or significant disability/incapacity (permanent or substantial 
disruption of a person’s ability to conduct normal life functions) 
• Is a congenital anomaly/birth defect 
• Is a medically important event that may not be immediately life threatening or result in 
death or hospitalization but may jeopardize the subject and may require medical or surgical 
intervention to prevent one of the above listed outcomes. Examples of such events include, 
but are not limited to, allergic bronchospasm requiring intensive treatment in an emergency 
room or at home; blood dyscrasias or convulsions that do not result in inpatient 
hospitalization. 
Note: A spontaneous abortion will be considered an SAE, and must be reported per Reporting of 
SAEs under Section 9.5.3.6. 
9.6.3.4 
Assessment of Severity 
The severity assigned to an AE should be determined by the maximum severity of the AE. The 
categories described below should be used to estimate the severity of AEs: 
• Mild: Transient or mild discomfort; no limitation in activity; no medical 
intervention/therapy required 
• Moderate: Mild to moderate limitation in activity; some assistance may be needed; no or 
minimal medical intervention/therapy required 
• Severe: Marked limitation in activity; some assistance usually required; medical 
intervention/therapy required; hospitalization or prolongation of current hospitalization 
possible; may be incapacitating or life threatening 


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9.6.3.5 
Assessment of Causality 
The PI should assess the relationship of the AE to the study drug as either “Related” or “Not 
Related”. The following should be taken into account when assessing AE causality: 
• Related: There is at least a reasonable possibility that the AE/SAE is related to the study 
drug. Reasonable possibility means that there is evidence to suggest a causal relationship 
between the drug and the AE. 
• Not Related: There is little or no reasonable possibility that the AE/SAE is related to the 
study drug. This assessment implies that the AE/SAE has little or no temporal relationship 
to the study drug and/or a more likely or certain alternative etiology exists. 
9.6.3.6 
Reporting of Serious Adverse Events 
Adverse events classified as “serious” require expeditious handling and reporting to Sponsor or 
designee within 24 hours of investigational center notification to comply with regulatory 
requirements. 
All SAEs, whether related or unrelated to study drug, must be immediately reported to the ethica 
CRO within 24 hours of the PI’s awareness of the event. All SAEs must be reported via confirmed 
facsimile or email transmission and must be submitted on a written SAE report form signed by the 
PI within 24 hours of the PI’s awareness of the event. Please refer to the SLI-C40-001 Safety 
and Medical Monitoring Plan for the listing of appropriate contacts. 
PIs should not wait to receive additional information to fully document the event before notifying 
ethica CRO of an SAE. If only limited information is initially available, follow-up reports are 
required. Additional relevant information such as hospital records and autopsy reports should be 
provided to the Sponsor as soon as they are available. Should the PI become aware of an SAE 
(regardless of its relationship to IP) that occurs within 30 days after stopping the study drug, the 
SAE must be reported in accordance with procedures specified in this protocol. 
All deaths of subjects, regardless of cause, and which are known to the PI will be reported on the 
appropriate CRF for up to 30 days after the administration of study drug, regardless of the PI's 
opinion regarding drug relationship. Documentation of the subject’s cause of death and a copy of 
the autopsy/hospital report will also be provided. The Medical Monitor must be notified within 24 
hours of knowledge of the event by telephone (and/or fax/email) of all subject deaths. Written 
follow-up must be received by ethica CRO within five (5) calendar days of initial notification. 
The PI should take all appropriate measures to ensure the safety of the subjects, notably he/she 
should follow a subject with an SAE until the event has resolved or the condition has stabilized. 
This may imply that follow-up will continue after the subject has left the study, and that additional 
investigations may be requested by the Sponsor. When an SAE persists at the end of the study, the 
PI will conduct follow-up contacts with the subject until the PI/Sponsor agree the event is 
satisfactorily resolved and/or stabilized. If at any time after 30 days after administration of study 
drug, the PI becomes aware of an SAE which he/she feels is related to study drug or procedure, 
this must also be reported immediately (within 24 hours of knowledge of occurrence) by telephone 
and confirmed facsimile transmission/email to ethica CRO. 
9.6.3.7 
Expedited Serious Adverse Event Reports 
Expedited SAE reports are those that are both unexpected based on the reference document 
(Investigator Brochure) and are related (i.e., the relationship cannot be ruled out) to the study drug. 


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These expedited reports are subject to reporting timelines of 7 and/or 15 calendar days to the 
regulatory reporting agency(ies). The Sponsor will notify regulatory authorities of these SAEs and 
all participating investigational centers in writing for submission by the PI to the IRB. 
Upon receiving such notices, the PI must review and retain the notice with the Investigator 
Brochure and immediately submit a copy of this information to the responsible IRB according to 
local regulations. The PI and IRB will determine if the informed consent requires revision. The PI 
should also comply with the IRB procedures for reporting any other safety information. 
9.6.3.8 
Pregnancy 
During Parts A and B, all female subjects of childbearing potential must use an effective method 
of birth control (as defined in Section 5.1) during the course of the study, in a manner such that 
risk of contraceptive failure is minimized. Abstinence is allowed as a birth control method. 
Before enrolling a female subject of childbearing potential in this clinical trial, the PI must review 
the following information about study participation: 
• Informed consent requirements 
• Contraceptives in current use 
Following review of this information and appropriate subject counseling, the PI or designee 
(obtaining the consent) and the subject must sign the informed consent before study enrolment. 
During the study, all female subjects of childbearing potential should be instructed to contact the 
PI immediately if they suspect they might be pregnant (e.g., missed or late menstrual period). 
If a subject or PI suspects that the subject may be pregnant prior to study enrolment, the study drug 
must be withheld until the results of laboratory pregnancy testing are available. If pregnancy is 
confirmed, the subject must not receive study drug and must not be enrolled in the study. 
If pregnancy is suspected while the subject is receiving study treatment, the study drug must 
immediately be withheld until the result of pregnancy testing is known. If pregnancy is confirmed, 
the study drug will be permanently discontinued, and the subject will be followed until the 
pregnancy comes to term. 
For Part B-Extension, all female subjects of childbearing potential are not required to use a birth 
control method as pregnancy will not impact their study participation. However, if they suspect 
they might be pregnant (e.g., missed or late menstrual period), they should be instructed to contact 
the PI immediately.  
All confirmed pregnancies must be reported via confirmed facsimile or email transmission and 
must be submitted on an Unanticipated Problem Reporting form within 24 hours of the PI’s 
awareness of the pregnancy. Any pregnancy complications that meet the criteria of a SAE (e.g., a 
spontaneous abortion, stillbirth, congenital anomaly, etc.) are considered SAEs. The SAE form 
must be submitted of PI awareness using the same reporting as procedure for an SAE under Section 
9.6.3.6. 


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10 STATISTICS 
All statistical processing will be performed using SAS® version 9.4 or later. Statistical significance 
will be based on two-tailed tests of the null hypothesis resulting in p-values of 0.05 or less. A 
statistical analysis plan (SAP), describing all statistical analyses will be provided as a separate 
document. The SAP will be finalized prior to unblinding of the study treatments. 
10.1 
Sample Size Determination 
Approximately 25 subjects will be enrolled. This is a POC study and a formal sample size 
justification is not required for this study. It is the opinion of the Sponsor that a total of 25 subjects 
will be sufficient to achieve the objectives of the study. 
10.2 
Assessments of Efficacy 
Efficacy analyses will be conducted on an intent-to-treat (ITT) basis (see Section 10.4). 
For categorical parameters, the number and percentage of subjects/observations in each category 
will be presented. The denominator will be based on the number of subjects/observations 
appropriate for the purpose of analysis. For continuous parameters, descriptive statistics will 
include n (number of subjects or observations), mean, standard deviation, median, and range. 
Comparisons between treatment groups will be performed using parametric or non-parametric 
testing, as appropriate. 
10.3 
Assessment of Safety 
For Parts A and B, safety analysis will be conducted on the Safety Population (SAFT), by 
tabulations of AEs, safety laboratory parameters and immunogenicity outcomes. 
Subjects will be followed for AEs (local and systemic) throughout the study. Events specific to 
treatment sites will be recorded by excision site (Study Part A) and per side (Study Part B) to allow 
comparison of study treatments. 
For Part B Extension, Safety analysis will be conducted on the ITT population. Subjects will be 
followed for Treatment-Related AEs (local and systemic) throughout the study. 
10.3.1 
Adverse Events 
All AEs occurring during the study will be recorded and classified on the basis of MedDRA 
terminology. Descriptions of AEs will include the date of onset, the date the AE ended, the severity 
of the AE, the relationship to study medication, the action taken regarding study medication usage, 
the action taken to treat the AE, and the outcome. All reported treatment-emergent AEs (TEAEs) 
will be summarized by the number of Subjects reporting AEs, system organ class, severity, 
seriousness, and relationship to study medication. TEAEs are those AEs with an onset on or after 
the date of initial IP exposure. 
AEs will be summarized by treatment group and severity, and by treatment group and relationship 
to IP. Each subject will be counted only once within a system organ class or a preferred term by 
using the AEs with the greatest relationship within each category. 
All information pertaining to AEs noted during the study will be listed by subject, detailing 
verbatim given by the PI, preferred term, system organ class, start date, stop date, severity, actions 
taken, and drug relatedness. 


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10.3.2 
Safety Laboratory Tests 
Determination of clinical significance for all out-of-range laboratory values will be made by each 
PI, and Adverse Event reports will be generated as necessary. 
10.3.3 
Immunogenicity 
Changes from baseline in immunogenicity outcomes will be summarized with descriptive statistics 
and text, as appropriate. 
10.3.4 
Concomitant Medications 
All previous therapies and concomitant medications will be classified based on terminology from 
the WHO Drug Dictionary. Previous therapies and concomitant medications data will be presented 
in data listings. 
No concomitant medication will be recorded in the eCRF for Part B Extension.  
10.4 
Analysis Populations 
10.4.1 
Primary Population for Efficacy Analysis 
The ITT population will be the primary population for efficacy and safety analyses and will consist 
of all randomized subjects who received at least one injection of IP and provided at least one post-
baseline evaluation, and will be analyzed in the treatment group they were allocated. 
A per-protocol (PP) population will neither be identified nor analyzed.  
10.4.2 
Populations for Safety Analysis 
The SAFT population will be used for safety analysis and will consist of all randomized subjects 
who received one injection of IP, and will be analyzed as per the treatment actually received. 
10.4.3 
Sub-Populations 
A subset of subjects with a history of keloidal scarring will be analyzed for efficacy and safety in 
a separate report. Comparisons between this subject population and the general population will not 
be made. 
10.5 
Subject Disposition 
A tabulation of subject disposition will be provided which will include the numbers of subjects 
who enter, complete, and discontinue the study. The reasons for discontinuation will be included. 
10.6 
Protocol Deviations and Violations 
All protocol deviations and violations will be reported to the Sponsor and recorded throughout the 
study. A tabulation of protocol deviations will be included in the final study report. 
10.7 
Multicenter Issues 
The study will be conducted at multiple investigational centers in the United States with the 
intention of pooling the results for analysis. 
10.8 
Missing Efficacy Data Imputations 
Data will be analyzed as observed; no imputations will be made for missing data. 
10.9 
Statistical Hypothesis Testing and Control of Multiplicity 
Not Applicable. 


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10.10 Compliance 
No compliance analyses are planned. 
10.11 Interim Analyses 
An interim analysis will be performed utilizing data from study Part A. 
 


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11 QUALITY CONTROL AND QUALITY ASSURANCE 
11.1 
Study Monitoring 
An initiation visit will be conducted with the PI/OP, IDR and study coordinator(s) by Sponsor 
and/or its designee. During this meeting, an extensive review and discussion of the protocol, all 
study procedures, source documents, and eCRFs will be conducted. Evaluation scales will be 
reviewed extensively. 
The study monitors/clinical research associates will be trained prior to study initiation. Following 
this training, an overview of the study disease and study material background will be understood. 
Specific monitoring guidelines and procedures to be followed during monitoring visits will also 
be utilized. For Parts A and B, all data will be approximately 100% source document verified by 
the site monitors. All subject source records must be made available to the monitors. 
For Part B Extension, sites will be monitored remotely. On-site monitoring will not be conducted. 
The conduct of the study will be closely monitored by the Sponsor (or designate) following GCP 
guidelines. The reports of these verifications will also be archived with the study report. In 
addition, inspections or on-site audits may be carried out by local and/or federal authorities. The 
PIs will allow the Sponsor's representatives and any regulatory agency to examine all study 
records, corresponding subject medical records, clinical dispensing records and storage area, and 
any other documents considered source documentation. The PIs agree to assist the representative, 
if required. 
11.2 
Audits and Inspections 
The study will be conducted under the Sponsorship of the Sponsor in conformation with all 
appropriate local and federal regulations, as well as ICH guidelines. Interim and end-of-study 
audits of raw data, study files, and final report may be conducted by the Sponsor’s Quality 
Assurance Department or designee. 
The Sponsor is responsible for implementing and maintaining quality assurance and quality control 
systems to ensure that studies are conducted and data are generated, documented, and reported in 
compliance with the protocol, GCP, and applicable regulatory requirements. In addition, the 
Sponsor will be responsible for securing agreement from all involved parties to ensure direct 
access to all study related investigational centers, source data/documents, CRFs, and reports for 
the purpose of monitoring and auditing by the Sponsor, and inspection by regulatory authorities. 
11.3 
Protocol Deviations 
The PIs must read the protocol thoroughly and must follow the instructions exactly. 
A deviation from the protocol is an unintended and/or unanticipated departure from the procedures 
and/or processes approved by the Sponsor and the IRB and agreed to by the PI. Deviations usually 
have an impact on individual patients or a small group of patients and do not involve 
inclusion/exclusion or primary endpoint criteria. 
A protocol violation occurs when there is non-adherence to the protocol that results in a significant, 
additional risk to the patient, when the patient or PI has failed to adhere to significant protocol 
requirements (inclusion/exclusion criteria) and the patient was enrolled without prior Sponsor 
approval, or when there is non-adherence to FDA regulations and/or ICH GCP guideline. 


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The issue of noncompliance may be either on the part of the subject, the PI, or the study site staff. 
As a result of deviations, corrective actions are to be developed by the site and implemented 
promptly. 
It is the responsibility of the site to use continuous vigilance to identify and promptly report 
deviations to ethica CRO Inc. 
All protocol deviations and violations must be addressed in study subject source documents. A 
completed copy of the ethica CRO Inc. Protocol Deviation Form must be maintained in the 
regulatory file, as well as in the subject’s source document. Protocol deviations must be sent to the 
IRB per its guidelines. 
The protocol must be rigorously adhered to; however, exceptions will be made in emergency 
situations when the protection, safety, and well-being of the subject requires immediate 
intervention based on the judgment of the PI. 
 
 


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12 ETHICS AND ADMINISTRATIVE ISSUES 
12.1 
Ethical Conduct of the Study 
This study will be conducted in accordance with the ethical principles originating from the 
Declaration of Helsinki, ICH guidelines, GCP, and in compliance with local regulatory 
requirements. The PI agrees, when signing the protocol, to adhere to the instructions and 
procedures described in it and thereby to adhere to the principles of GCP. 
12.2 
Ethics Review 
This protocol, proposed informed consent form and other information to subjects, and all 
appropriate amendments will be reviewed and approved by an Institutional Review Board (IRB). 
A signed and dated notification of the IRB approval will be provided to the Sponsor and PI prior 
to study initiation. The name and occupation of the chairman and members of the IRB will be 
supplied to the Sponsor to the extent allowable by the IRB. The PI will provide required progress 
reports and report all SAEs to the IRB as required by the IRB. 
12.3 
Written Informed Consent 
This study will be conducted in compliance with 21 CFR Part 50 for informed consent.  
Written informed consent will be obtained from each subject before any procedures or assessments 
are done and after the aims, methods, anticipated benefits, potential hazards, compensation and/or 
honoraria, and insurance arrangements are in force. It will also be explained to the subject that 
they are free to refuse entry into the study and free to withdraw from the study at any time without 
prejudice to future treatment. 
The site will keep the original consent forms and copies will be given to the subjects. 
12.4 
Subject Data Protections 
Subject data will be protected by ensuring that no captured data contain subject names, addresses, 
telephone numbers, email addresses, or other personally identifying information. It is 
acknowledged that subject initials, demographics (including birthdates), medical histories, and 
prior concomitant medication uses, along with the name and address of the enrolling PI may allow 
for personal identification of study participants. Other than where necessary to meet regulatory 
requirements, all data collected in this study will be presented in tabulated (i.e., aggregate) form 
and listings containing information that could be used to identify an individual subject will not be 
included in any public disclosures of the study data or the study results. 
12.5 
Data Monitoring Committee 
Not applicable. 
12.6 
Financial Disclosure 
Financial disclosures will be obtained from Investigators and Co-Investigators to document any 
potential conflicts of interest. 
12.7 
Investigator Obligation 
The PI agrees, when signing the protocol, to adhere to the instructions and procedures described 
in it and thereby to adhere to the principles of Good Clinical Practice (GCP). 
12.8 
Changes to the Protocol 
The PIs must read the protocol thoroughly and must follow the instructions exactly. Whenever 


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possible, any planned deviations should be agreed to by prior discussion between the Sponsor and 
the PI, with appropriate documentation of Sponsor approval prior to effecting the changes agreed 
upon. Any amendment to the protocol containing major modifications (particularly if it may 
involve an increased risk to the subjects) will be approved by the IRB before it may be 
implemented. No change in the conduct of the study can be instituted without written approval 
from the Sponsor. 
12.9 
Confidentiality Regarding Study Subjects 
All the data furnished to the PI and his/her staff and all data obtained through this protocol will be 
regarded as confidential and proprietary in nature and will not be disclosed to any third party, 
except for the FDA or other regulatory body, without written consent from the Sponsor. 
12.10 Information to Study Personnel 
The PI, with the assistance of ethica CRO Inc., is responsible for ensuring that all study personnel 
are qualified for their designated roles and for providing information about the study to all staff 
members involved in the study or in any element of subject management, both before starting the 
practical performance of the study and during the course of the study (e.g., when new staff become 
involved). 
The ethica CRO Inc. site monitor is responsible for initiating the site, for ensuring site compliance 
with the protocol and for closing out the site at the end of the study. Additional information 
available during the study should be given as agreed upon, either by the PI or the site monitor, and 
always when new staff members become involved in the study. 
12.11 Reporting and Publication of Results 
Scarless Laboratories Inc., as the Sponsor, has a proprietary interest in this study. Authorship and 
manuscript composition will reflect joint cooperation among multiple PIs and sites and Scarless 
Laboratories Inc. personnel. Authorship will be established prior to the writing of the manuscript. 
As this study involves multiple sites, no individual publications will be allowed prior to completion 
of the final report of the multicenter study except as agreed with Scarless Laboratories Inc. 
All information, including but not limited to information regarding the IP or the Sponsor’s 
operations supplied by the Sponsor to the PI and not previously published, along with any data 
generated as a result of this study are considered confidential and remain the sole property of the 
Sponsor. The PI agrees to maintain this information in confidence and will use the information 
only to perform the study. 
The Sponsor or its designate is responsible for preparing a clinical study report. 
The Sponsor or its designate is responsible for publicly registering this study on 
http://www.clinicaltrials.gov prior to initiating enrolment. 
12.12 Financing and Insurance 
A separate financial agreement (Clinical Study Agreement) will be made between the Sponsor and 
the PI at each site. 
The study is covered under a Scarless Laboratories Inc. liability insurance policy. The certificate 
of insurance will be provided upon request. 
 


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13 DATA HANDLING AND RECORD KEEPING 
13.1 
Case Report Form 
In this study the case report form will be an eCRF. The study coordinator must complete the eCRF 
for each subject within a timely manner of the visit occurring. 
The site monitor, Clinical Project Manager (CPM), or Clinical Data Manager (CDM) will review 
the completed eCRF for accuracy, completeness and consistency with source documentation (i.e., 
medical records, source document worksheets, etc.). The site monitor or CDM will submit requests 
for correction/clarification of data (e.g., queries) to the study coordinator when inconsistencies are 
identified during monitoring and source data verification or during the edit check process.  
All corrections and alterations of eCRF data must be made by the study coordinator in a timely 
manner and according to the instructions provided. Completed eCRFs for each visit (i.e., those 
reviewed by ethica CRO Inc. and with no remaining queries) should then be reviewed and 
electronically signed by the PI. 
A full audit trail detailing corrections and alterations made to the eCRF will be maintained. 
Upon study completion, an electronic copy of the eCRF for each subject will be provided to the 
site. 
13.2 
Inspection of Records 
PIs must maintain detailed records on all study subjects who are enrolled in the study or undergo 
screening. Data will be recorded in the subject’s source documents and in applicable study logs 
provided by the Sponsor. Source documents include subject medical records, hospital charts, clinic 
charts, PI subject study files, as well as the results of diagnostic tests (e.g., laboratory tests). All 
required data should be recorded in the study documentation completely for prompt data review. 
Upon study completion or at any other time specified by the Sponsor or designee, the appropriate 
study documents must be submitted. 
The PI must keep accurate separate records (source documentation) of all subject visits, being sure 
to include all pertinent study related information. At a minimum, this includes the following 
information: 
• A statement indicating that the subject has been enrolled in the study and the subject 
number. 
• Date that informed consent was obtained. 
• Evidence that the subject meets study eligibility requirements (e.g., medical history, 
screening evaluations). 
• Dates of all study related visits and results of any evaluations/procedures performed, 
including who performed each assessment at each visit. 
• Use of any concurrent medications during the study. 
• Documentation of study drug accountability. 
• Any and all side effects and AEs must be thoroughly documented to conclusion of Part B.  
• Treatment related AEs must be thoroughly documented to conclusion of Part B Extension. 
• Results of any diagnostic tests conducted during the study. 
• The date the subject exited the study and a statement indicating that the subject completed 
the study or was discontinued early, including the reason for discontinuation. 


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Notes describing telephone conversations and all electronic mail with the subject or the Sponsor 
(Sponsor’s designee) concerning the study must be recorded or kept on file. All source documents 
must be made available to the Sponsor and the Sponsor’s designated monitor upon request. 
13.3 
Archiving of Study Documentation 
Essential documents are any records that demonstrate the compliance of the subject, PIs, Sponsor, 
and site monitor with the study protocol, with standards of GCP, and with all applicable regulatory 
requirements. Essential documents (including but not limited to study-related correspondence 
(including emails), subject records, subject privacy documentation, records of the distribution and 
use of the IP, and copies of eCRFs should be retained and available for audit by the Sponsor’s 
auditor and regulatory authorities until at least 2 years after the latest among the following 
scenarios: completion or termination of the study, the last approval of a marketing application, no 
pending or contemplated marketing applications, or formal discontinuation of clinical 
development of the IP. These documents should be retained for a longer period, however, if 
mandated by the applicable regulatory requirements, by conditions imposed by the IRB, or by an 
agreement with the Sponsor. It is the responsibility of the Sponsor to inform the PI when these 
documents no longer need to be retained.  
The Sponsor must be notified in writing if the PI chooses to store the records at a different physical 
address than the site address or if the PI wishes to relinquish ownership of the data so that mutually 
agreed-upon arrangements can be made for transfer of ownership to a suitably qualified, 
responsible person. 


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14 APPENDICES 
Appendix A:  Protocol Version History 
Appendix B:  Patient and Observer Scar Assessment Scale (POSAS) 
 
 


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APPENDIX A: PROTOCOL VERSION HISTORY 
Version and Date 
Description 
Version 1.0, 07-May-2018 
Initial protocol 
Version 1.1, 26-Jun-2018 
Clarifications provided to Section 6.5.3. 
Version 1.2, 31-Oct-2018 
1) Some text was modified/added to increase clarity and comprehension. 
2) Pannus maps were revised to permit additional space between excision 
sites as well as precision regarding skin strips to be used to test tensile 
strength. Overall, subjects will be exposed to slightly fewer excisions 
during Part A of the study. Text has been appropriately modified 
throughout the protocol to accommodate the new mapping. 
3) The study treatment will now be injected immediately prior to closing 
wounds, as opposed to injections immediately after closure. 
4) Protocol sections have been added to define Pre-operative Preparation 
and Patient Monitoring, Anesthetic Preparation and Administration, 
Excision Procedures, Administration of Investigational Product, and 
Wound Care. 
5) These amendments do not increase risk for study participants. 
Version 1.3, 15-Jan-2019 
1) The Pre-Screening Visit (day -45 to -15) and Screening (day -15 to 0) 
were combined into a single visit (i.e., Screening Period; day-30 to 0). 
2) Precision was made to confirm that safety laboratory results obtained 
during the Screening Period will be reviewed by the PI to confirm 
absence of any health condition(s) that would make the subject 
inappropriate for study entry. 
3) If the UPT conducted during the Screening Period was performed >7 
days of V2a, it will now be repeated prior to performing excisions. 
4) The timing for the removal of sutures post-abdominoplasty is now at the 
discretion of the Investigator (i.e., standard of care), rather than 
mandatorily occurring at 2b (day 8 post-abdominoplasty). 
5) To accommodate Investigators removing abdominoplasty sutures as per 
standard of care, a Suture Removal Visit added has been added to Part 
B of the study (timing to be at the discretion of the PI). 
6) Immunogenicity testing for ADAs at Visits 4b, 5b, 7b and 8b will now 
be conducted without consideration of previous test results (i.e., rather 
than subjects negative for ADAs at a preceding visit not be re-tested). 
7) Photography will now be conducted at Visit 2A (pre- and post-
excision). 
8) The POSAS will now also be conducted at Visit 3a (post-suture 
removal). 
9) Text describing administration of IP for excisions (Section 6.5.8) has 
been edited to be concise and more precise. 
10) Text describing administration of IP for abdominoplasty (Section 6.6.4) 
has been edited to be concise and more precise. 
11) Excision site mapping has been simplified with the use of paper pannus 
maps and sterilizable ink stamps. 
12) The maximal exposure to lidocaine while conducting excisions has been 
now defined as 7mg/kg. 
13) Incisional surgery of any kind from the level of the umbilicus to the 
knees has been added to the list of prohibited procedures (Section 


Scarless Laboratories Inc. 
Protocol SLI-C40-001 
CONFIDENTIAL 
v.1.4; 20-Nov-2020 
Page 52 of 53 
6.7.1). 
14) The shelf-life of refrigerated reconstituted Investigational Product has 
been increased to 6 hours, up from 4 hours. 
15) Precision was made to confirm that randomization to treatment 
assignment for Part B will be independent of the randomization to 
treatment assignment for Part A (Section 6.2). 
16) The Subject assessment of POSAS will now be a secondary endpoint 
(abdominoplasty incisions/Part B) and an exploratory endpoint 
(excisions/Part A), rather than a primary endpoint (Section 9.4.2.1). 
Version 1.4, 13-Nov-2020 
1) Clarification that typical signs and symptoms after a minor excisional 
surgery are not to be considered adverse events unless meeting certain 
criteria (Sections 9.6.3.1 and 9.6.3.2). 
2) All current participants, whereas possible, will be moved to Group 1; 
12-week follow-up after excisions. All future participants will be 
enrolled in Group 1; 12-week follow-up after excision. (Section 4.1) 
3) Group 3; 4-week follow-up after excision was removed (Section 4.1) 
4) For part B, the IP will now be administered immediately after wound 
closure (not before wound closure as previously described). Injections 
will start 1 cm from the mid-point on each side of both wound edges 
and will proceed laterally (Sections 6.6.3 and 6.6.4). 
5) Addition of a 2 cm area at the midpoint of the incision that will have no 
IP administered (Sections 6.6.3 and 6.6.4). 
6) Addition of a secondary efficacy assessment. Each side of the 
abdominoplasty incision will be divided into 5cm sections starting from 
the midpoint and moving outwards to the end of the incision. The 
Participant will use the “Patient Scale” criteria of the POSAS and the 
PI will use the “Observer Scale” criteria of the POSAS to assess the 
middle 3cm section within each of the 5cm section (Sections 9.5.2.1 and 
9.5.2.2)    
7) The shelf-life of refrigerated reconstituted Investigational Product has 
been increased to 8 hours, up from 6 hours. 
8) Some text was modified/added to increase clarity and comprehension in 
Sections 9.6.1 and 9.6.2 
9) If photographs don’t meet the Sponsor and/or Photography Vendor 
quality standards, participants will be asked to return to the study site 
for a reshoot for V5b, V6b, V7b, and V8b (Sections 9.3.5 and 9.3.6). 
10)  If participant does not consent to study Part B extension, the 
participant study exit date is the date the last V8b photography report is 
received or the date the participant declines additional reshoot 
photography sessions (Section 9.3.6.) 
11) Protocol sections and wording have been updated to incorporate details 
about addition of Part B extension. Protocol has been extended for an 
additional 12 months to assess the efficacy of SLI-F06 treatment on 
abdominoplasty incision scar appearance over a longer period of time 
12) Addition of wording on how participants will be recruited and 
consented for the Part B extension (Section 4.1) 
13) These amendments do not increase risk for study participants. 
 
 
 


Scarless Laboratories Inc. 
Protocol SLI-C40-001 
CONFIDENTIAL 
v.1.4; 20-Nov-2020 
Page 53 of 53 
APPENDIX B: PATIENT AND OBSERVER SCAR ASSESSMENT SCALE 
POSAS Observer Scale 
 
 
POSAS Patient Scale 
 
 

SAP_001.pdf: 
Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A)  
CONFIDENTIAL 
 
 NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 1 of 23 
 
 
STATISTICAL ANALYSIS PLAN 
 
STUDY NUMBER:  SLI-C40-001 
Study Part A (Excisions) 
 
Version:   v. 1.0 
Date:   09-Oct-2020 
 
Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in 
Pre-Abdominoplasty Surgical Excisions and Post-Operative Scar Appearance 
in Subjects Undergoing Abdominoplasty 
 
Study Sponsor 
Scarless Laboratories Inc. 
369 South Doheny Drive, Suite 1201 
Beverly Hills, CA 
USA 90211 
 
 
Clinical Research Organization 
ethica CRO Inc. 
8555 Transcanada Hwy, Suite 201 
Montreal, Canada H4S 1Z6 
866-384-4221 
 
 
 
 
 
 
 
 
 
Confidentiality Statement 
The information contained in this document is provided in confidence. It is 
understood that this information will not be disclosed to others without prior 
agreement with the Sponsor, except to other study personnel and to the extent 
necessary to obtain informed consent from participating subject. 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A)  
CONFIDENTIAL 
 
 NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 2 of 23 
SAP APPROVAL SIGNATURE PAGE 
 
The following individuals approve this version of the SLI-C40-001 Part A Statistical Analysis 
Plan. 
 
Accepted for the Sponsor – Scarless Laboratories Inc. 
___________________________  ______________________________  
Printed Name 
Title 
___________________________  ______________________________   
Signature 
Date 
 
 
Accepted for the Clinical Research Organization - ethica CRO Inc. 
___________________________  ______________________________  
Printed Name 
Title 
___________________________  ______________________________   
Signature 
Date 
 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A)  
CONFIDENTIAL 
 
 NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 3 of 23 
TABLE OF CONTENTS 
 
SAP APPROVAL SIGNATURE PAGE .................................................................................................................... 2 
TABLE OF CONTENTS ............................................................................................................................................ 3 
ABBREVIATIONS ...................................................................................................................................................... 4 
1 
INTRODUCTION ......................................................................................................................................... 5 
1.1 
Background ............................................................................................................................................ 5 
1.2 
Objectives .............................................................................................................................................. 6 
1.3 
Study Design .......................................................................................................................................... 6 
2 
STUDY POPULATION ................................................................................................................................ 8 
3 
TREATMENT ALLOCATION AND RANDOMIZATION ..................................................................... 8 
4 
STUDY EVALUATIONS ............................................................................................................................. 8 
4.1 
Primary Efficacy Variable ..................................................................................................................... 8 
4.1.1 
POSAS (PI Assessment) – Excisions .......................................................................................................... 8 
4.2 
Secondary Efficacy Variables ................................................................................................................ 8 
4.2.1 
Histology ......................................................................................................................................................... 8 
4.2.2 
Tensile Strength ............................................................................................................................................. 8 
4.3 
Exploratory Efficacy Variable ............................................................................................................... 8 
4.3.1 
POSAS (Subject Assessment) – Excisions ................................................................................................ 8 
4.4 
Safety Variables ..................................................................................................................................... 8 
4.4.1 
Adverse Events (AEs) ................................................................................................................................... 8 
4.4.2 
Clinical Safety Laboratory Tests ................................................................................................................. 8 
4.4.3 
Immunogenicity Testing ............................................................................................................................... 8 
4.4.4 
Concomitant Medications and Procedures ................................................................................................. 8 
5 
ANALYSIS POPULATIONS ....................................................................................................................... 9 
5.1 
Populations ............................................................................................................................................ 9 
5.1.1 
Intent-to-Treat (ITT) Population .................................................................................................................. 9 
5.1.2 
Per Protocol (PP) Population ........................................................................................................................ 9 
5.1.3 
Safety (SAFT) Population ............................................................................................................................ 9 
6 
SAMPLE SIZE JUSTIFICATION .............................................................................................................. 9 
7 
STATISTICAL METHODS ......................................................................................................................... 9 
7.1 
Efficacy Analyses .................................................................................................................................. 9 
7.2 
Safety Analyses ..................................................................................................................................... 9 
7.3 
Adverse Events (AEs) ............................................................................................................................ 9 
7.4 
Concomitant Medications and Procedures ........................................................................................... 10 
7.5 
Safety Laboratory Tests ....................................................................................................................... 10 
7.6 
Immunogenicity ................................................................................................................................... 10 
7.7 
General Statistical Considerations ....................................................................................................... 10 
7.7.1 
Statistical Testing ......................................................................................................................................... 10 
7.7.2 
Descriptive Statistics ................................................................................................................................... 10 
7.7.3 
Missing Values ............................................................................................................................................. 10 
7.7.4 
Discontinuation and Drop-Outs ................................................................................................................. 10 
7.7.5 
Multiple Comparisons ................................................................................................................................. 10 
7.7.6 
Multicenter Data ........................................................................................................................................... 10 
7.7.7 
Subject Disposition ...................................................................................................................................... 10 
7.7.8 
Outliers .......................................................................................................................................................... 11 
 
APPENDIX A:  SUMMARY OF STATISTICAL TESTS ................................................................................. 12 
APPENDIX B:  STATISTICAL TABLES ......................................................................................................... 14 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A)  
CONFIDENTIAL 
 
 NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 4 of 23 
ABBREVIATIONS 
AE 
Adverse Event 
BL 
Baseline 
BMI 
Body Mass Index 
CFR 
U. S. Code of Federal Regulations 
CTR 
Common Treatment Response 
CRO 
Clinical Research Organization 
DP 
Drug Product 
Excision site  
A mapped area designated for a single excision. 
eCRF 
electronic Case Report Form 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
MedDRA 
Medical Dictionary for Regulatory Activities 
PI 
Principal Investigator 
POC 
Proof Of Concept 
POSAS 
Patient and Observer Scar Assessment Scale 
PP 
Per protocol 
PT 
Preferred Term 
SAE 
Serious Adverse Event 
SAFT 
Safety 
SAP 
Statistical Analysis Plan 
SOC 
System Organ Class 
TEAE 
Treatment Emergent Adverse Event 
TRAE 
Treatment Related Adverse Event 
Tx 
Treatment 
UPT 
Urine Pregnancy Test 
USP 
United States Pharmacopeia 
 
 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A)  
CONFIDENTIAL 
 
 NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 5 of 23 
1 
INTRODUCTION 
This statistical analysis plan (SAP) gives a comprehensive and detailed description of statistical 
techniques to be used for study SLI-C40-001. The purpose of this SAP is to ensure the credibility 
of the study findings by pre-specifying the statistical approaches for the analysis of study data prior 
to database lock. This SAP provides additional details concerning the statistical analyses outlined 
in the protocol. Whenever differences exist in descriptions or explanations provided in the protocol 
and SAP, the SAP prevails.   
1.1 
Background 
SLI-F06 is a synthetic peptide that is being developed as a treatment to promote wound healing 
and improve scar appearance. The amino acid sequence of SLI-F06 is derived from an endogenous 
human protein that has been shown in animal models to promote accelerated wound healing, 
reduced scarring, and increased wound tensile strength. In these same animal models, the SLI-F06 
has been demonstrated to retain similar pro-migration, pro-tensile strength, and anti-fibrotic 
properties as the endogenous protein. 
SLI-F06 drug product (DP) is a sterile lyophilized powder consisting of SLI-F06 as the active 
ingredient and formulation buffer components. The DP will be reconstituted in clinic with USP 
Water for Injection and injected intradermally along both edges of a freshly made excision to 
achieve a primarily local effect.  
The study population will consist of healthy patients planning to undergo elective abdominoplasty. 
During Part A of this study (i.e., Phase I Safety/Proof of Concept), each subject will receive 12, 
14, or 18 small or large excisions at 8 weeks or 12 weeks pre-abdominoplasty. Wounds treated 
with SLI-F06 or vehicle will be followed until the time of abdominoplasty when the tissue is 
harvested. At the completion of study Part A, subjects will enter study Part B where they will 
undergo the abdominoplasty, have the abdominoplasty incision treated with SLI-F06, and be 
followed for an additional 12 months. 
 
This SAP covers Study Part A only 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A)  
CONFIDENTIAL 
 
 NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 6 of 23 
1.2 
Objectives 
The primary objectives of this study are the following: 
• Assess the safety and tolerability of SLI-F06 in the treatment of planned surgical 
excisions. 
Secondary objectives include, but are not limited to, the following: 
• Assess the effect of SLI-F06 on post-excisional scar appearance. 
• Assess the effect of SLI-F06 on wound strength. 
• Assess the effect of SLI-F06 on histological appearance of scars. 
• Assess immunogenicity effects of SLI-F06. 
1.3 
Study Design 
This is a multicenter, double-blind study comparing the safety of SLI-F06 to control formulation 
buffer (vehicle), as well as comparing the improvement in scar appearance and wound strength. 
Each subject will serve as his or her own control. The study is divided into 2 parts where Part A is 
a Phase I safety/proof of concept study of small scars pre-abdominoplasty, and Part B is a Phase 
IIa study of post-abdominoplasty scars. 
In Part A of the study (i.e., Phase I safety/proof-of-concepts. Subjects will then be randomized by 
side of the pannus (right or left) for treatment with SLI-F06 or formulation buffer, wound tension 
(high or low), and by duration of follow-up post-excisions to 12 weeks (group 1) or 8 weeks (group 
2) pre-abdominoplasty. Excision mapping and number of excisions will be determined by size of 
pannus as follows: 
• Small pannus: 6 low tension and 6 high tension wounds will (12 wounds/subject). 
• Medium pannus: 6 low tension and 8 high tension wounds will (14 wounds/subject). 
• Large pannus: 8 low tension and 10 high tension wounds (18 wounds/subject).  
Following completion of the follow-up period, the entire abdominoplasty site will be harvested 
and sent for analyses of histopathology and tensile strength. 
In Part B of the study (i.e., Phase IIa), ALL subjects who complete Part A will be randomly 
assigned to receive injections of SLI-F06 along one half (left or right) of the abdominoplasty 
incision and control injections along the other half. The subject will undergo routine wound care 
and will attend study follow-up visits following abdominoplasty at Day 8 and at Months 1, 2, 3, 6, 
9, and 12. 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 7 of 23 
 
STUDY SUMMARY 
 
 
 
1 UPT if female of childbearing potential and if last UPT performed >7 days of V2a. 
2 Safety laboratory results to be reviewed by the PI prior to excisions in order to confirm absence of any health condition(s) that would make the subject inappropriate for study entry. 
3 Day 1 photography occurs prior to excisions and following closure of all excisions, and Day 8 photography occurs pre- and post-removal of sutures. 
4 Only currently enrolled participants who cannot be moved from group 2 to group 1 will remain in group 2 
 
 
Part A (Phase I Safety/Proof of Concept) 
Part B (Phase IIa) 
Visit Number 
1a 
2a 
3a 
4a 
5a 
6a 
1b 
2b 
SR 
3b 
4b 
5b 
6b 
7b 
8b 
Assessment and Procedures 
Screening 
Period 
Excisions 
Suture 
Removal  
 
  
 
Abdomin-
oplasty 
 
 
Suture 
Removal 
 
 
 
 
 
 
D -30 
to 0 
D1 
D8 
± 1d 
D29 
± 2d 
D57 
± 3d 
D85 
± 3d 
D0 
D8 
± 1d 
PI 
Discretion 
M1 
± 3d 
M2 
± 7d 
M3 
± 14d 
M6 
± 14d 
M9 
± 14d 
M12 
± 14d 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inc/Excl Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical/Surgical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Exam 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Test 1 
X 
X 1 
 
 
 
 
X 
 
 
 
 
X 
X 
X 
X 
Abdominoplasty Area Assessment 
& selection of Pannus Map size 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Immunogenicity sampling 
X 
 
X 
X 
X 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
Safety Laboratory Testing 2 
X 2 
 
 
X 
Group 2 
Group 1 
 
 
 
X 
 
 
 
 
X 
Photography 3 
 
X 3 
X 3 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
Randomization 
 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Excisions 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
IP Injections 
 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Abdominoplasty/ Tissue 
Harvesting 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Suture removal 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
POSAS grading 
 
 
Post-removal 
of sutures 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
AE Assessment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Group 1; 12 week assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exit from Part A / Start of Part B 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Group 2; 8 week assessment4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exit from Part A / Start of Part B 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 8 of 23 
2 
STUDY POPULATION 
Healthy adult subjects presenting for abdominoplasty surgery will be enrolled and randomized. 
The full description of the inclusion and exclusion criteria is found in Section 5 of the study 
protocol. 
3 
TREATMENT ALLOCATION AND RANDOMIZATION 
All excisions to be treated with SLI-F06 for a given subject will be on one side of the mapped area 
(i.e., left side or right side) and vehicle treated excisions will be on the other side of the mapped 
area. 
4 
STUDY EVALUATIONS 
4.1 
Primary Efficacy Variable 
4.1.1 
POSAS (PI Assessment) – Excisions 
The Patient and Observer Scar Assessment Scale  (POSAS) will be used to assess the various 
parameters of each excision site. At each observation time point, the PI will grade each scar using 
the “Observer Scale” of the POSAS. 
4.2 
Secondary Efficacy Variables 
4.2.1 
Histology 
Histology of excision sites will be evaluated and reported separately from the analyses described 
in this SAP. 
4.2.2 
Tensile Strength 
Ex vivo tensile strength of excision sites will be assessed and compared. 
4.3 
Exploratory Efficacy Variable 
4.3.1 
POSAS (Subject Assessment) – Excisions 
Subjects will grade the abdominoplasty scar using the “Patient Scale” criteria of the POSAS. 
4.4 
Safety Variables 
4.4.1 
Adverse Events (AEs) 
The Treating Investigator will assess AEs and record details of seriousness, severity, duration, and 
action taken with the study device, and relationship to the study device. 
4.4.2 
Clinical Safety Laboratory Tests 
Standard clinical laboratory analyses (CBC/Diff, chemistry) will be conducted on blood samples 
collected at Screening V1a, V4a (D29), V5a (D57), V6a (D85). Clinically significant results, in 
the opinion of the PI, will be reported as AEs.  
4.4.3 
Immunogenicity Testing 
Immunogenicity analyses will be conducted on blood samples collected from subjects at Screening 
V1a, V3a (D8), V4a (D29), V5a (D57) and V6a (D85). 
4.4.4 
Concomitant Medications and Procedures 
Any medication or procedure (including OTC preparations) that the subject takes during the study 
protocol period will be considered concomitant medication and will recorded. 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 9 of 23 
5 
ANALYSIS POPULATIONS 
5.1 
Populations 
5.1.1 
Intent-to-Treat (ITT) Population 
The ITT population will be the primary population for efficacy and safety analyses and will consist 
of all randomized subjects who received at least one injection of IP and provided at least one post-
baseline evaluation, and will be analyzed in the treatment group they were allocated. 
5.1.2 
Per Protocol (PP) Population 
A per-protocol (PP) population will neither be identified nor analyzed.  
5.1.3 
Safety (SAFT) Population 
The SAFT population will be used for safety analysis and will consist of all randomized subjects 
who received one injection of IP, and will be analyzed as per the treatment actually received. 
6 
SAMPLE SIZE JUSTIFICATION 
This is a Phase I safety/proof-of-concept study and a formal sample size justification is not 
required. It is the opinion of the Sponsor that a total of 25 subjects will be sufficient to achieve the 
objectives of the study. 
7 
STATISTICAL METHODS 
7.1 
Efficacy Analyses 
Efficacy analyses will be conducted on an intent-to-treat (ITT) basis. 
For categorical parameters, the number and percentage of subjects/observations in each category 
will be presented. The denominator will be based on the number of subjects/observations 
appropriate for the purpose of analysis. For continuous parameters, descriptive statistics will 
include n (number of subjects or observations), mean, standard deviation, median, and range. 
Comparisons between treatment groups will be based on 95% confidence intervals. 
7.2 
Safety Analyses 
Safety analysis will be conducted on the Safety Population (SAFT), by tabulations of AEs, safety 
laboratory parameters and immunogenicity outcomes. 
7.3 
Adverse Events (AEs) 
Safety outcomes will be incidence rate of AEs, including SAEs, types of AEs and relationship to 
study treatment (i.e., Treatment-Emergent Adverse Events [TEAEs]; Treatment-Related-Adverse 
Events [TRAEs]). TEAEs will include all reported AE since the time of informed consent. TRAEs 
will include all reported AEs that were deemed by the Investigator to be related or not-related to 
study treatment. 
Safety data will be tabulated with descriptive group statistics (mean, standard deviation, minimum, 
maximum). Severity and relationship to study treatment will be assessed. 
AEs will be coded using MedDRA. These events, irrespective of relationship to study medication, 
will be summarized by treatment groups, MedDRA system organ class (SOC) and MedDRA 
preferred term (PT). The number of subjects reporting an AE, the number of AEs, and percentages 
of subjects in each category will be summarized. AEs by severity and relationship to study will be 
summarized in a similar way. Serious AEs will be summarized separately. Specifically, the 
following AE incidence tables will be provided: 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 10 of 23 
• Treatment-Emergent AEs:  Sorted By SOC and PT 
• Treatment-Related AEs:  Sorted By SOC and PT 
• Treatment-Emergent SAEs:  Sorted By SOC and PT 
• Treatment-Related SAEs:  Sorted By SOC and PT 
AE incidence rates with exact 95% confidence intervals will be calculated for each safety variable; 
confidence intervals will be used to confirm whether distribution of subjects with events is 
homogeneous between the treatment groups. 
7.4 
Concomitant Medications and Procedures 
Descriptive statistics (i.e., frequency and percent) will be calculated for each treatment group. 
7.5 
Safety Laboratory Tests 
Determination of clinical significance for all out-of-range laboratory values will be made by each 
PI, and Adverse Event reports will be generated as necessary. 
7.6 
Immunogenicity 
Changes from baseline in immunogenicity outcomes will be summarized with descriptive statistics 
and text, as appropriate. 
7.7 
General Statistical Considerations 
7.7.1 
Statistical Testing 
For specific information regarding the statistical tests to be used in this study, please refer to 
Appendix A: Summary of Statistical Tests.  Comparisons between treatment groups will be based 
on 95% confidence intervals. 
7.7.2 
Descriptive Statistics 
Descriptive statistics (i.e., frequency and percent) will be calculated for each treatment group.  
Quantitative variables will be presented by way of number of observations, number of missing 
values, mean, standard deviation, extreme values (minimum and maximum), median, and 95% 
confidence internals.  Categorical data will be presented by way of number of observations, 
number of missing values, and for each observed category, the number of occurrences and its 
corresponding percentage, and 95% confidence internals. 
7.7.3 
Missing Values 
Missing data will not be imputed. Data will be analyzed as observed. 
7.7.4 
Discontinuation and Drop-Outs 
Dropouts will not be replaced. All available data from dropouts will be included in the ITT 
analysis. 
7.7.5 
Multiple Comparisons 
No methods will be used to accommodate multiplicity (unless otherwise specified). 
7.7.6 
Multicenter Data 
The data will be pooled across centers for analysis. Additionally, data for each center will be 
provided in data listings. 
7.7.7 
Subject Disposition 
A tabulation of subject disposition will be provided which will include the numbers of subjects 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 11 of 23 
who enter, complete, and discontinue the study. The reasons for discontinuation will be included. 
7.7.8 
Outliers 
No method to process outliers will be used.  Data will be analyzed as reported in the database. 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 12 of 23 
APPENDIX A:  SUMMARY OF STATISTICAL TESTS 
 
STUDY DISPOSITION 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Populations 
Statistical 
Tests 
Subject discontinuations 
Listing: 
- Last Visit 
- Reason for discontinuing  
Exit Form 
IIT 
-- 
Primary Reason for 
discontinuations 
Categorical 
Exit Form 
IIT 
-- 
Disposition at each Visit 
Frequency of subjects attending visit 
All Visits 
IIT 
-- 
Study dates 
- FPFV 
- LPFV 
- LPLV 
- Enrolment duration 
- Study duration 
All Visits 
IIT 
-- 
 
 
BASELINE CHARACTERISTICS 
Demographics 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Populations 
Statistical Tests 
Age 
Quantitative (years) 
V1a (Scr) 
IIT 
95% CI 
BMI 
Quantitative 
V1a (Scr) 
IIT 
95% CI 
Gender 
Categorical 
V1a (Scr) 
IIT 
-- 
Race 
Categorical 
V1a (Scr) 
IIT 
-- 
Ethnicity 
Categorical 
V1a (Scr) 
IIT 
-- 
Keloid Hx 
Categorical 
V1a (Scr) 
IIT 
-- 
Smoking Hx 
Categorical 
V1a (Scr) 
IIT 
-- 
Pannus Size 
Categorical 
V1a (Scr) 
IIT 
-- 
 
 
Medical History 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Populations 
Statistical Tests 
Medical Hx 
Categorical  
V1a (Scr) 
IIT 
-- 
 
 
Concomitant Medications/Treatment 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Populations 
Statistical Tests 
Medication 
Categorical  
ConMed Form 
IIT 
-- 
 
 
 


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Page 13 of 23 
EFFICACY ANALYSIS 
PATIENT AND OBSERVER SCAR ASSESSMENT SCALE (POSAS; Excisions) 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Population 
Statistical Tests 
POSAS (PI) 
Quantitative 
V3a (D8) 
V4a (D29) 
V5a (D57) 
V6a (D85) 
IIT 
95% CI 
POSAS (Subject) 
Quantitative 
V3a (D8) 
V4a (D29) 
V5a (D57) 
V6a (D85) 
IIT 
95% CI 
 
 
TENSILE STRENGTH 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Population 
Statistical Tests 
Tensile Strength 
Quantitative 
V5a (D57) 
V6a (D85) 
IIT 
95% CI 
 
 
SAFETY ANALYSES 
IMMUNOGENICITY 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Population 
Statistical Tests 
Immunogenicity 
Categorical (positive / negative) 
V1a (D0) 
V3a (D8) 
V4a (D29) 
V5a (D57) 
V6a (D85) 
IIT 
95% CI 
 
ADVERSE EVENTS 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Population 
Statistical Tests 
Adverse Events (number of subjects with and 
number of events): 
- All Adverse Events 
- Treatment-Emergent Adverse Events 
- Treatment-Related Adverse Events 
- Serious Adverse Events 
 
Categorical 
AE Form 
SAFT 
95% CI 
 


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Page 14 of 23 
APPENDIX B:  STATISTICAL TABLES 
 
14.1 SUBJECT DISPOSITION .................................................................................................................................. 15 
Table 14.1.1  Enrolment ..................................................................................................................................... 15 
Table 14.1.2  Listing of Subject Discontinuations ............................................................................................. 15 
Table 14.1.3  Subject Disposition per Visit........................................................................................................ 15 
Table 14.1.4  Study Dates – Part A .................................................................................................................... 15 
14.2 DEMOGRAPHIC, BASELINE, AND CON-MED DETAILS ................................................................................. 16 
Table 14.2.1  Demographics .............................................................................................................................. 16 
Table 14.2.2  Inclusion Criteria .......................................................................................................................... 17 
Table 14.2.3  Exclusion Criteria......................................................................................................................... 17 
Table 14.2.4  Medical / Surgical  History .......................................................................................................... 18 
Table 14.2.5  Concomitant Medications/Treatment ........................................................................................... 18 
14.3 EFFICACY DATA ........................................................................................................................................... 19 
Table 14.3.1  POSAS (PI Assessment, Excisions) ............................................................................................. 19 
Table 14.3.2  POSAS (Subject Assessment, Excisions) .................................................................................... 20 
Table 14.3.4  Tensile Strength ........................................................................................................................... 21 
Table 14.3.5  Histology ...................................................................................... Error! Bookmark not defined. 
14.4  SAFETY DATA ................................................................................................................................................ 21 
Table 14.4.1  Immunogenicity ........................................................................................................................... 21 
Table 14.4.2  AE Profile Overview – Part A ...................................................................................................... 22 
Table 14.4.3  Treatment-Emergent AEs Sorted by SOC – Part A ..................................................................... 22 
Table 14.4.4  Treatment-Related AEs Sorted by SOC – Part A ......................................................................... 22 
Table 14.4.5  Treatment-Emergent SAEs Sorted by SOC – Part A ................................................................... 23 
Table 14.4.6  Treatment-Related SAEs Sorted by SOC – Part A ...................................................................... 23 
 
 
 
 


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Page 15 of 23 
14.1 Subject Disposition  
Table 14.1.1  Enrolment   
Site 
Screened Screen Failures Randomized ITT 
SAFT 
01 
xx 
xx 
xx 
xx 
xx 
02 
xx 
xx 
xx 
xx 
xx 
03 
xx 
xx 
xx 
xx 
xx 
All sites xx 
xx 
xx 
xx 
xx 
Number of Participants 
 
 
Table 14.1.2  Listing of Subject Discontinuations 
Subject 
Number 
Treatment 
Group 
Gender* 
Age 
Last 
Visit 
Primary Reason for 
Discontinuation 
#### 
Active 
M/F 
xx 
V# 
xxxxxxxxxxxxxxxxxxx 
#### 
Active 
M/F 
xx 
V# 
xxxxxxxxxxxxxxxxxxx 
#### 
Control 
M/F 
xx 
V# 
xxxxxxxxxxxxxxxxxxx 
#### 
Active 
M/F 
xx 
V# 
xxxxxxxxxxxxxxxxxxx 
M=Male, F=Female 
 
 
Table 14.1.3  Subject Disposition per Visit 
Disposition of Subjects at each Study Visit 
n = xx 
N 
xx 
V1a (Scr) 
xx (xx.x%) 
V2a (BL/Excisions) 
xx (xx.x%) 
V3a (D8) 
xx (xx.x%) 
V4a (D29) 
xx (xx.x%) 
V5a (D57) 
xx (xx.x%) 
V6a (D85) 
xx (xx.x%) 
Number of participants (% in parenthesis) 
 
 
Table 14.1.4  Study Dates – Part A 
FPFV 
LPFV 
LPLV 
Enrollment Duration 
Study Duration 
dd-mmm-yyyy 
dd-mmm-yyyy 
dd-mmm-yyyy 
xxx 
xxx 
FPFV= First Participant First Visit, LPFV= Last Participant First Visit, LPLV= Last Participant Last Visit. Enrollment duration=FPFV-
LPFV+1, Study duration=FPFV-LPLV+1 
 
 


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Page 16 of 23 
14.2 Demographic, Baseline, and Con-Med Details 
Table 14.2.1  Demographics 
Demographics 
 
 n = xx 
Age 
N 
xx 
 
Mean ± SD 
xx.x  ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx, xx 
 
Missing values  
xx 
BMI 
N 
xx 
 
Mean ± SD 
xx.x  ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx, xx 
 
Missing values  
xx 
Gender 
N 
xx 
 
Male 
xx (xx.x%)  
 
Female 
xx (xx.x%)  
 
Missing values  
xx 
Race 
N 
xx 
 
American Indian or Alaska Native  
xx (xx.x%)  
 
Asian 
xx (xx.x%)  
 
Black or African American 
xx (xx.x%)  
 
Caucasian 
xx (xx.x%)  
 
Hawaiian / Pacific Islander  
xx (xx.x%)  
 
Other 
xx (xx.x%)  
 
Missing values  
xx 
Ethnicity 
N 
xx 
 
Hispanic 
xx (xx.x%)  
 
Non-Hispanic 
xx (xx.x%)  
 
Missing values  
xx 
Keloid/Hyp Hx 
N 
xx 
 
Yes 
xx (xx.x%)  
 
No 
xx (xx.x%)  
 
Missing values  
xx 
Smoking Hx 
N 
xx 
 
Non-Smoker 
xx (xx.x%)  
 
Smoker 
xx (xx.x%)  
 
Ex-Smoker 
xx (xx.x%)  
 
Missing values  
xx 
Pannus Size 
N 
xx 
 
Small 
xx (xx.x%)  
 
Medium 
xx (xx.x%)  
 
Large 
xx (xx.x%)  
 
Missing values  
xx 
95% CI [xx.x, xx.x], Mean ± standard deviation. Number of Participants (% in parenthesis). 
 
 


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Page 17 of 23 
 
Table 14.2.2  Inclusion Criteria 
Inclusion Criteria 
 
 
 n = xx 
Inclusion 1 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 2 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 3 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 4 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 5 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 6 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Number of participants (% in parenthesis). 
 
Table 14.2.3  Exclusion Criteria 
Exclusion Criteria 
 
 
 n = xx 
Exclusion 1 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 2 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 3 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 4 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 5 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 6 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 7 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 8 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 9 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 10 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 11 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 12 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 13 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 14 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 15 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 16 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Number of participants (% in parenthesis). 
 
 


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Page 18 of 23 
 
Table 14.2.4  Medical / Surgical  History 
Medical / Surgical History 
 
n = xx 
1. Blood and lymphatic system disorders 
 
xx (xx.x%) 
2. Cardiac/Vascular disorders 
 
xx (xx.x%) 
3. Eye/Ear and labyrinth disorders 
 
xx (xx.x%) 
4. Endocrine disorders 
 
xx (xx.x%) 
5. Gastrointestinal/Hepatobiliary disorders 
 
xx (xx.x%) 
6. General disorders and administration site conditions 
 
xx (xx.x%) 
7. Immune system disorders 
 
xx (xx.x%) 
8. Infections and infestations 
 
xx (xx.x%) 
9. Injury, poisoning and procedural complications 
 
xx (xx.x%) 
10. Metabolism and nutrition disorders 
 
xx (xx.x%) 
11. Musculoskeletal and connective tissue disorders 
 
xx (xx.x%) 
12. Neoplasms benign, malignant and unspecified 
 
xx (xx.x%) 
13. Nervous system disorders 
 
xx (xx.x%) 
14. Psychiatric disorders 
 
xx (xx.x%) 
15. Renal and urinary disorders 
 
xx (xx.x%) 
16. Reproductive system and breast disorders 
 
xx (xx.x%) 
17. Respiratory, thoracic and mediastinal disorders 
 
xx (xx.x%) 
18. Skin and subcutaneous tissue disorders 
 
xx (xx.x%) 
19. Surgical and medical procedures 
 
xx (xx.x%) 
20. Allergies 
 
xx (xx.x%) 
21. Other 
 
xx (xx.x%) 
Number of Participants (% in parenthesis). 
 
Table 14.2.5  Concomitant Medications/Treatment 
Concomitant Medication/Treatment 
n = xx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
Number of Participants (% in parenthesis). 
 
 


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Page 19 of 23 
14.3 Efficacy Data  
Table 14.3.1  POSAS (PI Assessment, Excisions) 
POSAS (PI) 
 
Active 
Control 
V3a (D8) 
Low Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
High Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
All Excisions  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V4a (D29) Low Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
High Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
All Excisions  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V5a (D57) Low Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
High Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
All Excisions  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V6a (D85) Low Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
High Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
All Excisions  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
N = # of excisions,  95% CI [xx.x, xx.x],  Mean ± standard deviation 
 


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Table 14.3.2  POSAS (Subject Assessment, Excisions) 
POSAS (Subject) 
 
Active 
Control 
V3a (D8) 
Low Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
High Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
All Excisions  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V4a (D29) Low Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
High Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
All Excisions  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V5a (D57) Low Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
High Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
All Excisions  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V6a (D85) Low Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
High Tension  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
All Excisions  N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
N = # of excisions,  95% CI [xx.x, xx.x],  Mean ± standard deviation 
 


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v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 21 of 23 
 
Table 14.3.4  Tensile Strength 
Tensile Strength 
 
Active 
Control 
V5a (D57) Low Tension N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
High Tension N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
All Excisions N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
V6a (D85) Low Tension N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
High Tension N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
All Excisions N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
95% CI [xx.x, xx.x] 
Mean ± standard deviation 
 
 
14.4  Safety Data 
Table 14.4.1  Immunogenicity 
Immunogenicity 
n = xx 
V1a (D0) 
N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
V3a (D8) 
N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
V4a (D29) N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
V5a (D57) N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
V6a (D85) N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
95% CI [xx.x, xx.x] 


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SLI-C40-001 – SAP (Study Part A) 
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v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 22 of 23 
Table 14.4.2  AE Profile Overview – Part A  
 
 
Active 
(n = xx) 
Control 
(n = xx) 
All 
(n = xx) 
Participants with any TEAEa 
Participants 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
 
Events 
xxx 
xxx 
xxx 
Participants with any TRAEb 
Participants 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
 
Events 
xxx 
xxx 
xxx 
Participants with any SAEc 
Participants 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
 
Events 
xxx 
xxx 
xxx 
Participants with any TRSAEd 
Participants 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
 
Events 
xxx 
xxx 
xxx 
95% CI [xx.x, xx.x].  aTEAE= Treatment-Emergent Adverse Events.  b TRAE= Treatment-Related Adverse Events.  
cSAE= Serious Adverse Events.  dTRSAE= Treatment-Related Serious Adverse Events.  
 
 
Table 14.4.3  Treatment-Emergent AEs Sorted by SOC – Part A 
 
 
Active 
(n = xx) 
Control 
(n = xx) 
 
All 
(n = xx) 
 
SOC 
PT 
Participants 
Events 
Participants 
Events 
Participants 
Events 
Any TEAE 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
XXXXXXX 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
95% CI [xx.x, xx.x].   
 
Table 14.4.4  Treatment-Related AEs Sorted by SOC – Part A 
 
 
Active 
(n = xx) 
Control 
(n = xx) 
 
All 
(n = xx) 
 
SOC 
PT 
Participants 
Events 
Participants 
Events 
Participants 
Events 
Any TRAE 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
XXXXXXX 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
95% CI [xx.x, xx.x].   
 
 


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v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 23 of 23 
 
Table 14.4.5  Treatment-Emergent SAEs Sorted by SOC – Part A 
 
 
Active 
(n = xx) 
Control 
(n = xx) 
 
All 
(n = xx) 
 
SOC 
PT 
Participants 
Events 
Participants 
Events 
Participants 
Events 
Any TESAE 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
XXXXXXX 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
95% CI [xx.x, xx.x].   
 
 
Table 14.4.6  Treatment-Related SAEs Sorted by SOC – Part A 
 
 
Active 
(n = xx) 
Control 
(n = xx) 
 
All 
(n = xx) 
 
SOC 
PT 
Participants 
Events 
Participants 
Events 
Participants 
Events 
Any TRSAE 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
XXXXXXX 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
95% CI [xx.x, xx.x].   
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B)  
CONFIDENTIAL 
 
 
 
NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 1 of 27 
 
 
STATISTICAL ANALYSIS PLAN 
 
STUDY NUMBER:  SLI-C40-001 
Study Part B (Abdominoplasty) 
 
Version:   v. 1.0 
Date:   09-Oct-2020 
 
Safety and Efficacy of SLI-F06 in Wound Healing and Scar Appearance in 
Pre-Abdominoplasty Surgical Excisions and Post-Operative Scar Appearance 
in Subjects Undergoing Abdominoplasty 
 
Study Sponsor 
Scarless Laboratories Inc. 
369 South Doheny Drive, Suite 1201 
Beverly Hills, CA 
USA 90211 
 
 
Clinical Research Organization 
ethica CRO Inc. 
8555 Transcanada Hwy, Suite 201 
Montreal, Canada H4S 1Z6 
866-384-4221 
 
 
 
 
 
 
 
 
 
 
Confidentiality Statement 
The information contained in this document is provided in confidence. It is 
understood that this information will not be disclosed to others without prior 
agreement with the Sponsor, except to other study personnel and to the extent 
necessary to obtain informed consent from participating subject. 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B)  
CONFIDENTIAL 
 
 
 
NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 2 of 27 
SAP APPROVAL SIGNATURE PAGE 
 
The following individuals approve this version of the SLI-C40-001 Part B Statistical Analysis 
Plan. 
 
Accepted for the Sponsor – Scarless Laboratories Inc. 
___________________________  ______________________________  
Printed Name 
Title 
___________________________  ______________________________   
Signature 
Date 
 
 
Accepted for the Clinical Research Organization - ethica CRO Inc. 
___________________________  ______________________________  
Printed Name 
Title 
___________________________  ______________________________   
Signature 
Date 
 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B)  
CONFIDENTIAL 
 
 
 
NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 3 of 27 
TABLE OF CONTENTS 
 
SAP APPROVAL SIGNATURE PAGE .................................................................................................................... 2 
TABLE OF CONTENTS ............................................................................................................................................ 3 
ABBREVIATIONS ...................................................................................................................................................... 4 
1 
INTRODUCTION ......................................................................................................................................... 5 
1.1 
Background ............................................................................................................................................ 5 
1.2 
Objectives .............................................................................................................................................. 6 
1.3 
Study Design .......................................................................................................................................... 6 
2 
STUDY POPULATION ................................................................................................................................ 8 
3 
TREATMENT ALLOCATION AND RANDOMIZATION ..................................................................... 8 
4 
STUDY EVALUATIONS ............................................................................................................................. 8 
4.1 
Primary Efficacy Variable ..................................................................................................................... 8 
4.1.1 
POSAS (PI Assessment) – Abdominoplasty Incisions ..................................................................... 8 
4.2 
Secondary Efficacy Variables ................................................................................................................ 8 
4.2.1 
POSAS (Subject Assessment) – Abdominoplasty Incisions ............................................................. 8 
4.3 
Exploratory Efficacy Variable ............................................................................................................... 8 
4.3.1 
POSAS (PI Assessment) – Abdominoplasty Incisions, 5cm Segments ............................................ 8 
4.3.2 
POSAS (Subject Assessment) – Abdominoplasty Incisions, 5cm Segments .................................... 8 
4.4 
Safety Variables ..................................................................................................................................... 8 
4.4.1 
Adverse Events (AEs) ....................................................................................................................... 8 
4.4.2 
Clinical Safety Laboratory Tests ....................................................................................................... 8 
4.4.3 
Immunogenicity Testing ................................................................................................................... 8 
4.4.4 
Concomitant Medications and Procedures ........................................................................................ 8 
5 
ANALYSIS POPULATIONS ....................................................................................................................... 9 
5.1 
Populations ............................................................................................................................................ 9 
5.1.1 
Intent-to-Treat (ITT) Population ....................................................................................................... 9 
5.1.2 
Per Protocol (PP) Population ............................................................................................................ 9 
5.1.3 
Safety (SAFT) Population ................................................................................................................. 9 
6 
SAMPLE SIZE JUSTIFICATION .............................................................................................................. 9 
7 
STATISTICAL METHODS ......................................................................................................................... 9 
7.1 
Efficacy Analyses .................................................................................................................................. 9 
7.2 
Safety Analyses ..................................................................................................................................... 9 
7.3 
Adverse Events (AEs) ............................................................................................................................ 9 
7.4 
Concomitant Medications and Procedures ........................................................................................... 10 
7.5 
Safety Laboratory Tests ....................................................................................................................... 10 
7.6 
Immunogenicity ................................................................................................................................... 10 
7.7 
General Statistical Considerations ....................................................................................................... 10 
7.7.1 
Statistical Testing ............................................................................................................................ 10 
7.7.2 
Descriptive Statistics ....................................................................................................................... 10 
7.7.3 
Missing Values ................................................................................................................................ 10 
7.7.4 
Discontinuation and Drop-Outs ...................................................................................................... 10 
7.7.5 
Multiple Comparisons ..................................................................................................................... 10 
7.7.6 
Multicenter Data ............................................................................................................................. 10 
7.7.7 
Sub-Populations .............................................................................. Error! Bookmark not defined. 
7.7.8 
Subject Disposition ......................................................................................................................... 11 
7.7.9 
Outliers ............................................................................................................................................ 11 
APPENDIX A:  SUMMARY OF STATISTICAL TESTS .............................................................................. 12 
APPENDIX B:  STATISTICAL TABLES ...................................................................................................... 14 
 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B)  
CONFIDENTIAL 
 
 
 
NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 4 of 27 
ABBREVIATIONS 
AE 
Adverse Event 
BL 
Baseline 
BMI 
Body Mass Index 
CFR 
U. S. Code of Federal Regulations 
CTR 
Common Treatment Response 
CRO 
Clinical Research Organization 
DP 
Drug Product 
Excision site  
A mapped area designated for a single excision. 
eCRF 
electronic Case Report Form 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
MedDRA 
Medical Dictionary for Regulatory Activities 
PI 
Principal Investigator 
POC 
Proof Of Concept 
POSAS 
Patient and Observer Scar Assessment Scale 
PP 
Per protocol 
PT 
Preferred Term 
SAE 
Serious Adverse Event 
SAFT 
Safety 
SAP 
Statistical Analysis Plan 
SOC 
System Organ Class 
TEAE 
Treatment Emergent Adverse Event 
TRAE 
Treatment Related Adverse Event 
Tx 
Treatment 
UPT 
Urine Pregnancy Test 
USP 
United States Pharmacopeia 
 
 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B)  
CONFIDENTIAL 
 
 
 
NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 5 of 27 
1 
INTRODUCTION 
This statistical analysis plan (SAP) gives a comprehensive and detailed description of statistical 
techniques to be used for study SLI-C40-001. The purpose of this SAP is to ensure the credibility 
of the study findings by pre-specifying the statistical approaches for the analysis of study data prior 
to database lock. This SAP provides additional details concerning the statistical analyses outlined 
in the protocol. Whenever differences exist in descriptions or explanations provided in the protocol 
and SAP, the SAP prevails.   
1.1 
Background 
SLI-F06 is a synthetic peptide that is being developed as a treatment to promote wound healing 
and improve scar appearance. The amino acid sequence of SLI-F06 is derived from an endogenous 
human protein that has been shown in animal models to promote accelerated wound healing, 
reduced scarring, and increased wound tensile strength. In these same animal models, the SLI-F06 
has been demonstrated to retain similar pro-migration, pro-tensile strength, and anti-fibrotic 
properties as the endogenous protein. 
SLI-F06 drug product (DP) is a sterile lyophilized powder consisting of SLI-F06 as the active 
ingredient and formulation buffer components. The DP will be reconstituted in clinic with USP 
Water for Injection and injected intradermally along both edges of a freshly made excision to 
achieve a primarily local effect.  
The study population will consist of healthy patients planning to undergo elective abdominoplasty. 
During Part A of this study (i.e., Phase I Safety/Proof of Concept), each subject will receive 12, 
14, or 18 small or large excisions at 8 weeks or 12 weeks pre-abdominoplasty. Wounds treated 
with SLI-F06 or vehicle will be followed until the time of abdominoplasty when the tissue is 
harvested. At the completion of study Part A, subjects will enter study Part B where they will 
undergo the abdominoplasty, have the abdominoplasty incision treated with SLI-F06, and be 
followed for an additional 12 months. 
 
This SAP covers Study Part B only 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B)  
CONFIDENTIAL 
 
 
 
NCT03880058  
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 6 of 27 
1.2 
Objectives 
The primary objectives of this study are the following: 
• Assess the safety and tolerability of SLI-F06 in the treatment of abdominoplasty 
incisions. 
Secondary objectives include, but are not limited to, the following: 
• Assess the effect of SLI-F06 on post-operative abdominoplasty scar appearance. 
• Assess immunogenicity effects of SLI-F06. 
1.3 
Study Design 
This is a multicenter, double-blind study comparing the safety of SLI-F06 to control formulation 
buffer (vehicle), as well as comparing the improvement in scar appearance and wound strength. 
Each subject will serve as his or her own control. The study is divided into 2 parts where Part A is 
a Phase I safety/proof of concept study of small scars pre-abdominoplasty, and Part B is a Phase 
IIa study of post-abdominoplasty scars. 
In Part A of the study (i.e., Phase I safety/proof-of-concepts. Subjects will then be randomized by 
side of the pannus (right or left) for treatment with SLI-F06 or formulation buffer, wound tension 
(high or low), and by duration of follow-up post-excisions to 12 weeks (group 1) or 8 weeks (group 
2) pre-abdominoplasty. Excision mapping and number of excisions will be determined by size of 
pannus as follows: 
• Small pannus: 6 low tension and 6 high tension wounds will (12 wounds/subject). 
• Medium pannus: 6 low tension and 8 high tension wounds will (14 wounds/subject). 
• Large pannus: 8 low tension and 10 high tension wounds (18 wounds/subject).  
Following completion of the follow-up period, the entire abdominoplasty site will be harvested 
and sent for analyses of histopathology and tensile strength. 
In Part B of the study (i.e., Phase IIa), ALL subjects who complete Part A will be randomly 
assigned to receive injections of SLI-F06 along one half (left or right) of the abdominoplasty 
incision and control injections along the other half. The subject will undergo routine wound care 
and will attend study follow-up visits following abdominoplasty at Day 8 and at Months 1, 2, 3, 6, 
9, and 12. 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 7 of 27 
 
STUDY SUMMARY 
 
 
 
1 UPT if female of childbearing potential and if last UPT performed >7 days of V2a. 
2 Safety laboratory results to be reviewed by the PI prior to excisions in order to confirm absence of any health condition(s) that would make the subject inappropriate for study entry. 
3 Day 1 photography occurs prior to excisions and following closure of all excisions, and Day 8 photography occurs pre- and post-removal of sutures. 
4 Only currently enrolled participants who cannot be moved from group 2 to group 1 will remain in group 2 
 
 
Part A (Phase I Safety/Proof of Concept) 
Part B (Phase IIa) 
Visit Number 
1a 
2a 
3a 
4a 
5a 
6a 
1b 
2b 
SR 
3b 
4b 
5b 
6b 
7b 
8b 
Assessment and Procedures 
Screening 
Period 
Excisions 
Suture 
Removal  
 
  
 
Abdomin-
oplasty 
 
 
Suture 
Removal 
 
 
 
 
 
 
D -30 
to 0 
D1 
D8 
± 1d 
D29 
± 2d 
D57 
± 3d 
D85 
± 3d 
D0 
D8 
± 1d 
PI 
Discretion 
M1 
± 3d 
M2 
± 7d 
M3 
± 14d 
M6 
± 14d 
M9 
± 14d 
M12 
± 14d 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Inc/Excl Criteria 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical/Surgical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Physical Exam 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine Pregnancy Test 1 
X 
X 1 
 
 
 
 
X 
 
 
 
 
X 
X 
X 
X 
Abdominoplasty Area Assessment 
& selection of Pannus Map size 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Immunogenicity sampling 
X 
 
X 
X 
X 
X 
 
X 
 
X 
X 
X 
X 
X 
X 
Safety Laboratory Testing 2 
X 2 
 
 
X 
Group 2 
Group 1 
 
 
 
X 
 
 
 
 
X 
Photography 3 
 
X 3 
X 3 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
Randomization 
 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Excisions 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
IP Injections 
 
X 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Abdominoplasty/ Tissue 
Harvesting 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
Suture removal 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
 
POSAS grading 
 
 
Post-removal 
of sutures 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
AE Assessment 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Group 1; 12 week assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exit from Part A / Start of Part B 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
Group 2; 8 week assessment4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Exit from Part A / Start of Part B 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B) 
CONFIDENTIAL 
 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 8 of 27 
2 
STUDY POPULATION 
Healthy adult subjects presenting for abdominoplasty surgery will be enrolled and randomized. 
The full description of the inclusion and exclusion criteria is found in Section 5 of the study 
protocol. 
3 
TREATMENT ALLOCATION AND RANDOMIZATION 
One side of the abdominoplasty incision will be treated with SLI-F06 (i.e., left side or right side) 
and the other side of the incision will be treated with vehicle. 
4 
STUDY EVALUATIONS 
4.1 
Primary Efficacy Variable 
4.1.1 
POSAS (PI Assessment) – Abdominoplasty Incisions 
The Patient and Observer Scar Assessment Scale (POSAS) will be used to assess the various 
parameters of the abdominoplasty incision. At each observation time point, the PI will grade each 
scar using the “Observer Scale” of the POSAS. 
4.2 
Secondary Efficacy Variables 
4.2.1 
POSAS (Subject Assessment) – Abdominoplasty Incisions 
Subjects will grade the abdominoplasty scar using the “Patient Scale” criteria of the POSAS. 
4.3 
Exploratory Efficacy Variable 
4.3.1 
POSAS (PI Assessment) – Abdominoplasty Incisions, 5cm Segments 
The Patient and Observer Scar Assessment Scale (POSAS) will be used to assess the various 
parameters of the abdominoplasty incision at 5cm intervals. At each observation time point, the PI 
will grade each scar using the “Observer Scale” of the POSAS. 
4.3.2 
POSAS (Subject Assessment) – Abdominoplasty Incisions, 5cm Segments 
The Patient and Observer Scar Assessment Scale (POSAS) will be used to assess the various 
parameters of the abdominoplasty incision at 5cm intervals. At each observation time point, the 
subject will grade each scar using the “Observer Scale” of the POSAS. 
4.4 
Safety Variables 
4.4.1 
Adverse Events (AEs) 
The Treating Investigator will assess AEs and record details of seriousness, severity, duration, and 
action taken with the study device, and relationship to the study device. 
4.4.2 
Clinical Safety Laboratory Tests 
Standard clinical laboratory analyses (CBC/Diff, chemistry) will be conducted on blood samples 
collected at V3b (M1) and V8b (M12). Clinically significant results, in the opinion of the PI, will 
be reported as AEs.  
4.4.3 
Immunogenicity Testing 
Immunogenicity analyses will be conducted at V2b (Day 8), V3b (M1), V4b (M2), V5b (M3), V6b 
(M6), V7b (M9), and V8b (M12).  
4.4.4 
Concomitant Medications and Procedures 
Any medication or procedure (including OTC preparations) that the subject takes during the study 
protocol period will be considered concomitant medication and will recorded. 


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5 
ANALYSIS POPULATIONS 
5.1 
Populations 
5.1.1 
Intent-to-Treat (ITT) Population 
The ITT population will be the primary population for efficacy and safety analyses and will consist 
of all randomized subjects who received at least one injection of IP and provided at least one post-
baseline evaluation, and will be analyzed in the treatment group they were allocated. 
5.1.2 
Per Protocol (PP) Population 
A per-protocol (PP) population will neither be identified nor analyzed.  
5.1.3 
Safety (SAFT) Population 
The SAFT population will be used for safety analysis and will consist of all randomized subjects 
who received one injection of IP, and will be analyzed as per the treatment actually received. 
6 
SAMPLE SIZE JUSTIFICATION 
This is a Phase IIa study and a formal sample size justification is not required. It is the opinion of 
the Sponsor that a total of 25 subjects will be sufficient to achieve the objectives of the study. 
7 
STATISTICAL METHODS 
7.1 
Efficacy Analyses 
Efficacy analyses will be conducted on an intent-to-treat (ITT) basis. 
For categorical parameters, the number and percentage of subjects/observations in each category 
will be presented. The denominator will be based on the number of subjects/observations 
appropriate for the purpose of analysis. For continuous parameters, descriptive statistics will 
include n (number of subjects or observations), mean, standard deviation, median, and range. 
Comparisons between treatment groups will be based on 95% confidence intervals. 
7.2 
Safety Analyses 
Safety analysis will be conducted on the Safety Population (SAFT), by tabulations of AEs, safety 
laboratory parameters and immunogenicity outcomes. 
Subjects will be followed for AEs (local and systemic) throughout the study. Events specific to 
treatment sites will be recorded per side to allow comparison of study treatments. 
7.3 
Adverse Events (AEs) 
Safety outcomes will be incidence rate of AEs, including SAEs, types of AEs and relationship to 
study treatment (i.e., Treatment-Emergent Adverse Events [TEAEs]; Treatment-Related-Adverse 
Events [TRAEs]). TEAEs will include all reported AE since the time of informed consent. TRAEs 
will include all reported AEs that were deemed by the Investigator to be related or not-related to 
study treatment. 
Safety data will be tabulated with descriptive group statistics (mean, standard deviation, minimum, 
maximum). Severity and relationship to study treatment will be assessed. 
AEs will be coded using MedDRA. These events, irrespective of relationship to study medication, 
will be summarized by treatment groups, MedDRA system organ class (SOC) and MedDRA 
preferred term (PT). The number of subjects reporting an AE, the number of AEs, and percentages 
of subjects in each category will be summarized. AEs by severity and relationship to study will be 
summarized in a similar way. Serious AEs will be summarized separately. Specifically, the 


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Page 10 of 27 
following AE incidence tables will be provided: 
• Treatment-Emergent AEs:  Sorted By SOC and PT 
• Treatment-Related AEs:  Sorted By SOC and PT 
• Treatment-Emergent SAEs:  Sorted By SOC and PT 
• Treatment-Related SAEs:  Sorted By SOC and PT 
AE incidence rates with exact 95% confidence intervals will be calculated for each safety variable; 
confidence intervals will be used to confirm whether distribution of subjects with events is 
homogeneous between the treatment groups. 
7.4 
Concomitant Medications and Procedures 
Descriptive statistics (i.e., frequency and percent) will be calculated for each treatment group. 
7.5 
Safety Laboratory Tests 
Determination of clinical significance for all out-of-range laboratory values will be made by each 
PI, and Adverse Event reports will be generated as necessary. 
7.6 
Immunogenicity 
Changes from baseline in immunogenicity outcomes will be summarized with descriptive statistics 
and text, as appropriate. 
7.7 
General Statistical Considerations 
7.7.1 
Statistical Testing 
For specific information regarding the statistical tests to be used in this study, please refer to 
Appendix A: Summary of Statistical Tests. Comparisons between treatment groups will be based 
on 95% confidence intervals. 
7.7.2 
Descriptive Statistics 
Descriptive statistics (i.e., frequency and percent) will be calculated for each treatment group.  
Quantitative variables will be presented by way of number of observations, number of missing 
values, mean, standard deviation, extreme values (minimum and maximum), median, and 95% 
confidence internals.  Categorical data will be presented by way of number of observations, 
number of missing values, and for each observed category, the number of occurrences and its 
corresponding percentage, and 95% confidence internals. 
7.7.3 
Missing Values 
Missing data will not be imputed. Data will be analyzed as observed. 
7.7.4 
Discontinuation and Drop-Outs 
Dropouts will not be replaced. All available data from dropouts will be included in the ITT 
analysis. 
7.7.5 
Multiple Comparisons 
No methods will be used to accommodate multiplicity (unless otherwise specified). 
7.7.6 
Multicenter Data 
The data will be pooled across centers for analysis. Additionally, data for each center will be 
provided in data listings. 


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7.7.7 
Subject Disposition 
A tabulation of subject disposition will be provided which will include the numbers of subjects 
who enter, complete, and discontinue the study. The reasons for discontinuation will be included. 
7.7.8 
Outliers 
No method to process outliers will be used.  Data will be analyzed as reported in the database. 
 
 


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APPENDIX A:  SUMMARY OF STATISTICAL TESTS 
 
STUDY DISPOSITION 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Populations 
Statistica
l Tests 
Subject discontinuations 
Listing: 
- Last Visit 
- Reason for discontinuing  
Exit Form 
IIT 
-- 
Primary Reason for 
discontinuations 
Categorical 
Exit Form 
IIT 
-- 
Disposition at each Visit 
Frequency of subjects attending visit 
All Visits 
IIT 
-- 
Study dates 
- FPFV 
- LPFV 
- LPLV 
- Enrolment duration 
- Study duration 
All Visits 
IIT 
-- 
 
 
BASELINE CHARACTERISTICS 
Demographics 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Populations 
Statistical Tests 
Age 
Quantitative (years) 
V1a (Scr) 
IIT 
95% CI 
BMI 
Quantitative 
V1a (Scr) 
IIT 
95% CI 
Gender 
Categorical 
V1a (Scr) 
IIT 
-- 
Race 
Categorical 
V1a (Scr) 
IIT 
-- 
Ethnicity 
Categorical 
V1a (Scr) 
IIT 
-- 
Keloid Hx 
Categorical 
V1a (Scr) 
IIT 
-- 
Smoking Hx 
Categorical 
V1a (Scr) 
IIT 
-- 
Pannus Size 
Categorical 
V1a (Scr) 
IIT 
-- 
 
 
Medical History 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Populations 
Statistical Tests 
Medical Hx 
Categorical  
V1a (Scr) 
IIT 
-- 
 
 
Concomitant Medications/Treatment 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Populations 
Statistical Tests 
Medication 
Categorical  
ConMed Form 
IIT 
-- 
 
 
 


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EFFICACY ANALYSIS 
PATIENT AND OBSERVER SCAR ASSESSMENT SCALE (POSAS; Excisions) 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Population 
Statistical Tests 
POSAS (PI) 
Quantitative 
V3b (M1) 
V4b (M2) 
V5b (M3) 
V6b (M6) 
V7b (M9) 
V8b (M12) 
IIT 
95% CI 
POSAS (Subject) 
Quantitative 
V3b (M1) 
V4b (M2) 
V5b (M3) 
V6b (M6) 
V7b (M9) 
V8b (M12) 
IIT 
95% CI 
POSAS (PI; 5cm 
Segment) 
Quantitative 
V5b (M3) 
V6b (M6) 
V7b (M9) 
V8b (M12) 
IIT 
95% CI 
POSAS (Subject; 
5cm Segment) 
Quantitative 
V5b (M3) 
V6b (M6) 
V7b (M9) 
V8b (M12) 
IIT 
95% CI 
 
 
 
SAFETY ANALYSES 
IMMUNOGENICITY 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Population 
Statistical Tests 
Immunogenicity 
Categorical (positive / negative) 
V2b (D8) 
V3b (M1) 
V4b (M2) 
V5b (M3) 
V6b (M6) 
V7b (M9) 
V8b (M12) 
IIT 
95% CI 
 
ADVERSE EVENTS 
Variable 
Type 
Visits / 
CRF Section 
Analyzed 
Population 
Statistical Tests 
Adverse Events (number of subjects with and 
number of events): 
- All Adverse Events 
- Treatment-Emergent Adverse Events 
- Treatment-Related Adverse Events 
- Serious Adverse Events 
 
Categorical 
AE Form 
SAFT 
95% CI 
 


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Page 14 of 27 
APPENDIX B:  STATISTICAL TABLES 
 
14.1 SUBJECT DISPOSITION .................................................................................................................................. 15 
Table 14.1.1  Enrolment ..................................................................................................................................... 15 
Table 14.1.2  Listing of Subject Discontinuations ............................................................................................. 15 
Table 14.1.3  Subject Disposition per Visit........................................................................................................ 15 
Table 14.1.4  Study Dates – Part B .................................................................................................................... 15 
14.2 DEMOGRAPHIC, BASELINE, AND CON-MED DETAILS ................................................................................. 16 
Table 14.2.1  Demographics .............................................................................................................................. 16 
Table 14.2.2  Inclusion Criteria .......................................................................................................................... 17 
Table 14.2.3  Exclusion Criteria......................................................................................................................... 17 
Table 14.2.4  Medical / Surgical  History .......................................................................................................... 18 
Table 14.2.5  Concomitant Medications/Treatment ........................................................................................... 18 
14.3 EFFICACY DATA ........................................................................................................................................... 19 
Table 14.3.1  POSAS (PI Assessment, Abdominoplasty, Full Scar) ................................................................. 19 
Table 14.3.2  POSAS (Subject Assessment, Abdominoplasty, Full Scar) ......................................................... 20 
Table 14.3.3  POSAS (PI Assessment, Abdominoplasty, 5cm Segments) ......................................................... 21 
Table 14.3.4  POSAS (Subject Assessment, Abdominoplasty, 5cm Segments) ................................................ 23 
14.4  SAFETY DATA ................................................................................................................................................ 25 
Table 14.4.1  Immunogenicity ........................................................................................................................... 25 
Table 14.4.2  AE Profile Overview – Part B ...................................................................................................... 26 
Table 14.4.3  Treatment-Emergent AEs Sorted by SOC – Part B ...................................................................... 26 
Table 14.4.4  Treatment-Related AEs Sorted by SOC – Part B ......................................................................... 26 
Table 14.4.5  Treatment-Emergent SAEs Sorted by SOC – Part B ................................................................... 27 
Table 14.4.6  Treatment-Related SAEs Sorted by SOC – Part B ....................................................................... 27 
 
 
 
 


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14.1 Subject Disposition  
Table 14.1.1  Enrolment   
Site 
Screened Screen Failures Randomized PP 
ITT 
SAFT 
01 
xx 
xx 
xx 
xx 
xx 
xx 
02 
xx 
xx 
xx 
xx 
xx 
xx 
03 
xx 
xx 
xx 
xx 
xx 
xx 
All sites xx 
xx 
xx 
xx 
xx 
xx 
Number of Participants 
 
 
Table 14.1.2  Listing of Subject Discontinuations 
Subject 
Number 
Treatment 
Group 
Gender* 
Age 
Last 
Visit 
Primary Reason for 
Discontinuation 
#### 
Active 
M/F 
xx 
V# 
xxxxxxxxxxxxxxxxxxx 
#### 
Active 
M/F 
xx 
V# 
xxxxxxxxxxxxxxxxxxx 
#### 
Control 
M/F 
xx 
V# 
xxxxxxxxxxxxxxxxxxx 
#### 
Active 
M/F 
xx 
V# 
xxxxxxxxxxxxxxxxxxx 
M=Male, F=Female 
 
 
Table 14.1.3  Subject Disposition per Visit 
Disposition of Subjects at each Study Visit 
n = xx 
N 
xx 
 
 
V1b (Abdominoplasty) 
xx (xx.x%) 
V2b (D8) 
xx (xx.x%) 
V3b (M1) 
xx (xx.x%) 
V4b (M2) 
xx (xx.x%) 
V5b (M3) 
xx (xx.x%) 
V6b (M6) 
xx (xx.x%) 
V7b (M9) 
xx (xx.x%) 
V8b (M12) 
xx (xx.x%) 
Number of Participants (% in parenthesis) 
 
 
Table 14.1.4  Study Dates – Part B 
FPFV 
LPFV 
LPLV 
Enrollment Duration 
Study Duration 
dd-mmm-yyyy 
dd-mmm-yyyy 
dd-mmm-yyyy 
xxx 
xxx 
FPFV= First Participant First Visit, LPFV= Last Participant First Visit, LPLV= Last Participant Last Visit. Enrollment duration=FPFV-
LPFV+1, Study duration=FPFV-LPLV+1 
 
 


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14.2 Demographic, Baseline, and Con-Med Details 
Table 14.2.1  Demographics 
Demographics 
 
n = xx 
Age 
N 
xx 
 
Mean ± SD 
xx.x  ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx, xx 
 
Missing values  
xx 
BMI 
N 
xx 
 
Mean ± SD 
xx.x  ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx, xx 
 
Missing values  
xx 
Gender 
N 
xx 
 
Male 
xx (xx.x%)  
 
Female 
xx (xx.x%)  
 
Missing values  
xx 
Race 
N 
xx 
 
American Indian or Alaska Native  
xx (xx.x%)  
 
Asian 
xx (xx.x%)  
 
Black or African American 
xx (xx.x%)  
 
Caucasian 
xx (xx.x%)  
 
Hawaiian / Pacific Islander  
xx (xx.x%)  
 
Other 
xx (xx.x%)  
 
Missing values  
xx 
Ethnicity 
N 
xx 
 
Hispanic 
xx (xx.x%)  
 
Non-Hispanic 
xx (xx.x%)  
 
Missing values  
xx 
Keloid/Hyp Hx 
N 
xx 
 
Yes 
xx (xx.x%)  
 
No 
xx (xx.x%)  
 
Missing values  
xx 
Smoking Hx 
N 
xx 
 
Non-Smoker 
xx (xx.x%)  
 
Smoker 
xx (xx.x%)  
 
Ex-Smoker 
xx (xx.x%)  
 
Missing values  
xx 
Pannus Size 
N 
xx 
 
Small 
xx (xx.x%)  
 
Medium 
xx (xx.x%)  
 
Large 
xx (xx.x%)  
 
Missing values  
xx 
95% CI [xx.x, xx.x], Mean ± standard deviation. Number of Participants (% in parenthesis). 
 
 


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Table 14.2.2  Inclusion Criteria 
Inclusion Criteria 
 
 
n = xx 
Inclusion 1 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 2 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 3 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 4 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 5 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Inclusion 6 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Number of Participants (% in parenthesis). 
 
Table 14.2.3  Exclusion Criteria 
Exclusion Criteria 
 
 
n = xx 
Exclusion 1 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 2 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 3 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 4 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 5 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 6 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 7 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 8 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 9 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 10 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 11 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 12 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 13 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 14 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 15 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Exclusion 16 
No 
 
xx (xx.x%) 
 
Yes 
 
xx (xx.x%) 
Number of Participants (% in parenthesis). 
 
 


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Table 14.2.4  Medical / Surgical  History 
Medical / Surgical History 
 
n = xx 
1. Blood and lymphatic system disorders 
 
xx (xx.x%) 
2. Cardiac/Vascular disorders 
 
xx (xx.x%) 
3. Eye/Ear and labyrinth disorders 
 
xx (xx.x%) 
4. Endocrine disorders 
 
xx (xx.x%) 
5. Gastrointestinal/Hepatobiliary disorders 
 
xx (xx.x%) 
6. General disorders and administration site conditions 
 
xx (xx.x%) 
7. Immune system disorders 
 
xx (xx.x%) 
8. Infections and infestations 
 
xx (xx.x%) 
9. Injury, poisoning and procedural complications 
 
xx (xx.x%) 
10. Metabolism and nutrition disorders 
 
xx (xx.x%) 
11. Musculoskeletal and connective tissue disorders 
 
xx (xx.x%) 
12. Neoplasms benign, malignant and unspecified 
 
xx (xx.x%) 
13. Nervous system disorders 
 
xx (xx.x%) 
14. Psychiatric disorders 
 
xx (xx.x%) 
15. Renal and urinary disorders 
 
xx (xx.x%) 
16. Reproductive system and breast disorders 
 
xx (xx.x%) 
17. Respiratory, thoracic and mediastinal disorders 
 
xx (xx.x%) 
18. Skin and subcutaneous tissue disorders 
 
xx (xx.x%) 
19. Surgical and medical procedures 
 
xx (xx.x%) 
20. Allergies 
 
xx (xx.x%) 
21. Other 
 
xx (xx.x%) 
Number of Participants (% in parenthesis). 
 
Table 14.2.5  Concomitant Medications/Treatment 
Concomitant Medication/Treatment 
n = xx 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx 
xx (xx.x%) 
Number of Participants (% in parenthesis). 
 
 


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14.3 Efficacy Data  
Table 14.3.1  POSAS (PI Assessment, Abdominoplasty, Full Scar) 
POSAS (PI) 
Active 
Control 
V3b (M1) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V4b (M2) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V5b (M3) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V6b (M6) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V7b (M9) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V8b (M12) N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
95% CI [xx.x, xx.x] 
Mean ± standard deviation 
 
 


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Table 14.3.2  POSAS (Subject Assessment, Abdominoplasty, Full Scar) 
POSAS (Subject) 
Active 
Control 
V3b (M1) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V4b (M2) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V5b (M3) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V6b (M6) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V7b (M9) 
N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
V8b (M12) N 
xx 
xx 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
95% CI [xx.x, xx.x] 
Mean ± standard deviation 
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 21 of 27 
Table 14.3.3  POSAS (PI Assessment, Abdominoplasty, 5cm Segments) 
POSAS (PI) 
Active 
Control 
V5b (M3) Seg 1 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 2 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 3 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD  
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 4 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 5 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 6 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Q1/2/3/4/5/6 Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V6b (M6) Seg 1 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 2 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 3 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD  
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 4 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 5 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 6 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Q1/2/3/4/5/6 Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
95% CI [xx.x, xx.x],  Mean ± standard deviation 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 22 of 27 
Table 14.3.3  POSAS (PI Assessment, Abdominoplasty, 5cm Segments)  con’t 
POSAS (PI) 
Active 
Control 
V7b (M9) 
Seg 1 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 2 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 3 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD  
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 4 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 5 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 6 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Q1/2/3/4/5/6 Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V8b (M12) Seg 1 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 2 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 3 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD  
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 4 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 5 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 6 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Q1/2/3/4/5/6 Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
95% CI [xx.x, xx.x],  Mean ± standard deviation 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 23 of 27 
Table 14.3.4  POSAS (Subject Assessment, Abdominoplasty, 5cm Segments) 
POSAS (Subject) 
Active 
Control 
V5b (M3) Seg 1 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 2 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 3 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD  
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 4 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 5 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 6 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Q1/2/3/4/5/6 Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V6b (M6) Seg 1 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 2 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 3 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD  
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 4 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 5 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 6 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Q1/2/3/4/5/6 Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
95% CI [xx.x, xx.x],  Mean ± standard deviation 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 24 of 27 
Table 14.3.3  POSAS (PI Assessment, Abdominoplasty, 5cm Segments)  con’t 
POSAS (Subject) 
Active 
Control 
V7b (M9) 
Seg 1 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 2 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 3 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD  
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 4 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 5 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 6 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Q1/2/3/4/5/6 Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
V8b (M12) Seg 1 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 2 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 3 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD  
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 4 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 5 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Seg 6 
N 
xx 
xx 
 
 
Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
Q1/2/3/4/5/6 Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
 
 
Median (P25, P75) xx.x (xx.x, xx.x) 
xx.x (xx.x, xx.x) 
 
 
Min, Max 
xx.x, xx.x 
xx.x, xx.x 
 
Opinion Mean ± SD 
xx.x ± xx.x [xx.x, xx.x] 
xx.x ± xx.x [xx.x, xx.x] 
95% CI [xx.x, xx.x],  Mean ± standard deviation 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part A) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 25 of 27 
14.4  Safety Data 
Table 14.4.1  Immunogenicity 
Immunogenicity 
n = xx 
V1a (D0) 
N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
V3a (D8) 
N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
V4a (D29) N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
V5a (D57) N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
V6a (D85) N 
xx 
 
Negative 
xx (xx.x%) [xx.x, xx.x] 
 
Positive 
xx (xx.x%) [xx.x, xx.x] 
 
Missing Data xx 
95% CI [xx.x, xx.x] 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 26 of 27 
Table 14.4.2  AE Profile Overview – Part B  
 
 
Active 
(n = xx) 
Control 
(n = xx) 
All 
(n = xx) 
Participants with any TEAEa 
Participants 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
 
Events 
xxx 
xxx 
xxx 
Participants with any TRAEb 
Participants 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
 
Events 
xxx 
xxx 
xxx 
Participants with any SAEc 
Participants 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
 
Events 
xxx 
xxx 
xxx 
Participants with any TRSAEd 
Participants 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
xx (xx.x%) [xx.x, xx.x] 
 
Events 
xxx 
xxx 
xxx 
95% CI [xx.x, xx.x].  aTEAE= Treatment-Emergent Adverse Events.  b TRAE= Treatment-Related Adverse Events.  
cSAE= Serious Adverse Events.  dTRSAE= Treatment-Related Serious Adverse Events.  
 
 
Table 14.4.3  Treatment-Emergent AEs Sorted by SOC – Part B 
 
 
Active 
(n = xx) 
Control 
(n = xx) 
 
All 
(n = xx) 
 
SOC 
PT 
Participants 
Events 
Participants 
Events 
Participants 
Events 
Any TEAE 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
XXXXXXX 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
95% CI [xx.x, xx.x].   
 
Table 14.4.4  Treatment-Related AEs Sorted by SOC – Part B 
 
 
Active 
(n = xx) 
Control 
(n = xx) 
 
All 
(n = xx) 
 
SOC 
PT 
Participants 
Events 
Participants 
Events 
Participants 
Events 
Any TEAE 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
XXXXXXX 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
95% CI [xx.x, xx.x].   
 
 


Scarless Laboratories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
SLI-C40-001 – SAP (Study Part B) 
CONFIDENTIAL 
v.1.0; 09-Oct-2020  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 27 of 27 
 
Table 14.4.5  Treatment-Emergent SAEs Sorted by SOC – Part B 
 
 
Active 
(n = xx) 
Control 
(n = xx) 
 
All 
(n = xx) 
 
SOC 
PT 
Participants 
Events 
Participants 
Events 
Participants 
Events 
Any TESAE 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
XXXXXXX 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
95% CI [xx.x, xx.x].   
 
 
Table 14.4.6  Treatment-Related SAEs Sorted by SOC – Part B 
 
 
Active 
(n = xx) 
Control 
(n = xx) 
 
All 
(n = xx) 
 
SOC 
PT 
Participants 
Events 
Participants 
Events 
Participants 
Events 
Any TRSAE 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
XXXXXXX 
 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
 
XXXXXXX 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
xx  (xx.x%) [ xx.x,  xx.x] 
xx 
95% CI [xx.x, xx.x].