Conditions: Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 440
Healthy volunteers: no

Brief summary:
Primary Objective:

-To evaluate the efficacy of a single 6-milliliter (mL) intra-articular (IA) injection of Hylan G-F 20 measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Numerical Rating Scale (NRS) 3.1 A1 score, in comparison to an IA placebo injection over 26 weeks, in Chinese participants with symptomatic Osteoarthritis (OA) of the knee.

Secondary Objectives:

* To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by 7-day average score of WOMAC A1 pain sub-score in comparison to an IA placebo injection over 26 weeks.
* To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by WOMAC A, patient global assessment (PTGA) and clinical observer global assessment (COGA) in comparison to an IA placebo injection over 26 weeks.
* To evaluate the response rate of a single 6-mL IA injection of Hylan G-F 20 in comparison to an IA placebo injection over 26 weeks. Response was defined as WOMAC A1 greater than or equal to (\>=) 2-point improvement from baseline on NRS.
* To evaluate the safety of a single 6-mL IA injection of Hylan G-F 20, in comparison to an IA placebo injection over 26 weeks.

Detailed description:
The duration of the study was 29 weeks at maximum. The screening and wash-out period lasted for up to 14 days, depending on the half-life of the medications followed by an 8-day baseline period including the treatment day. Overall, there were up to 21 days between signing informed consent (at screening visit) and the randomization (Day 1). Treatment was administered on Day 1, and follow-up period was 26 weeks.

Arms:
arm 1: Participants received a single IA injection of phosphate buffered saline on Day 1 and were observed for 26 weeks. arm 2: Participants received a single IA injection of 6 mL Hylan G-F 20 (Synvisc-One) on Day 1 and were observed for 26 weeks.

Interventions: intervention 1: Hylan G-F 20 (GZ402662/SAR402662) intervention 2: Placebo
Intervention descriptions: intervention 1: Pharmaceutical form: Solution for injection

Route of administration: Intra articular intervention 2: Pharmaceutical form: Solution for injection

Route of administration: Intra articular

Protocol document:
Prot_000.pdf: 
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ELECTRONIC SIGNATURES 
 
Signed by 
Meaning of Signature 
Server Date 
(dd-MMM-yyyy HH:mm) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EFC12723 Amended Protocol 01 - China
Regulatory Approval
20-Mar-2017 10:42 GMT+0100
Clinical Approval
20-Mar-2017 11:12 GMT+0100
Clinical Approval
20-Mar-2017 14:13 GMT+0100

SAP_001.pdf: 
Any and all information presented in this document shall be treated as confidential and shall remain the exclusive property of Sanofi (or any of its 
affiliated companies). The use of such confidential information must be restricted to the recipient for the agreed purpose and must not be 
disclosed, published or otherwise communicated to any unauthorized persons, for any reason, in any form whatsoever without the prior written 
consent of Sanofi (or the concerned affiliated company); ‘affiliated company’ means any corporation, partnership or other entity which at the date 
of communication or afterwards (i) controls directly or indirectly Sanofi, (ii) is directly or indirectly controlled by Sanofi, with ‘control’ meaning 
direct or indirect ownership of more than 50% of the capital stock or the voting rights in such corporation, partnership or other entity
According to template: QSD-002643 VERSION 6.0 (06-JUL-2016)
Page 1
STATISTICAL ANALYSIS PLAN
A 26-week, Multicenter, Double-blind, Randomized, Placebo-controlled Parallel 
Group Study to Evaluate the Efficacy and Safety of a Single Dose of 6 mL of hylan 
G-F 20 (Synvisc-One) in Chinese Patients With Symptomatic Osteoarthritis of the 
Knee 
GZ402662-EFC12723
STATISTICIAN: 
Statistical Project Leader: 
DATE OF ISSUE: 28-Jan-2019
Total number of pages:
40
(electronic 1.0)
NCT Number: NCT03190369


Statistical Analysis Plan
28-Jan-2019
GZ402662-EFC12723
Version number: 1
Property of the Sanofi Group - strictly confidential
Page 2
TABLE OF CONTENTS
STATISTICAL ANALYSIS PLAN ...................................................................................................................1
TABLE OF CONTENTS..................................................................................................................................2
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS..........................................................................5
1
OVERVIEW AND INVESTIGATIONAL PLAN ................................................................................6
1.1
STUDY DESIGN AND RANDOMIZATION ......................................................................................6
1.2
OBJECTIVES...................................................................................................................................6
1.2.1
Primary objectives............................................................................................................................6
1.2.2
Secondary objectives.......................................................................................................................6
1.2.3
Tertiary efficacy and other objectives ..............................................................................................7
1.3
DETERMINATION OF SAMPLE SIZE.............................................................................................7
1.4
STUDY PLAN...................................................................................................................................8
1.5
MODIFICATIONS TO THE STATISTICAL SECTION OF THE PROTOCOL..................................9
1.6
STATISTICAL MODIFICATIONS MADE IN THE STATISTICAL ANALYSIS PLAN .....................10
2
STATISTICAL AND ANALYTICAL PROCEDURES ....................................................................11
2.1
ANALYSIS ENDPOINTS ...............................................................................................................11
2.1.1
Demographic and baseline characteristics ....................................................................................11
2.1.2
Prior or concomitant medications...................................................................................................12
2.1.3
Efficacy endpoints..........................................................................................................................12
2.1.3.1
Primary efficacy endpoint(s) ..........................................................................................................13
2.1.3.2
Secondary efficacy endpoint(s)......................................................................................................13
2.1.4
Safety endpoints ............................................................................................................................14
2.1.4.1
Adverse events variables...............................................................................................................14
2.1.4.2
Deaths............................................................................................................................................15
2.1.4.3
Laboratory safety variables............................................................................................................15
2.1.4.4
Vital signs variables .......................................................................................................................15
2.1.5
Tertiary efficacy endpoints and other endpoint..............................................................................15
2.1.5.1
Tertiary efficacy endpoints .............................................................................................................15
2.1.5.2
Quality of life variables...................................................................................................................15
2.2
DISPOSITION OF PATIENTS .......................................................................................................15
2.2.1
Randomization and drug dispensing irregularities.........................................................................16
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2.3
ANALYSIS POPULATIONS...........................................................................................................17
2.3.1
Efficacy populations .......................................................................................................................17
2.3.1.1
Modified intent-to-treat population .................................................................................................17
2.3.2
Safety population ...........................................................................................................................17
2.3.3
Other analysis population ..............................................................................................................18
2.4
STATISTICAL METHODS .............................................................................................................18
2.4.1
Demographics and baseline characteristics ..................................................................................18
2.4.2
Prior or concomitant medications...................................................................................................18
2.4.3
Extent of investigational medicinal product exposure and compliance .........................................19
2.4.3.1
Extent of investigational medicinal product exposure....................................................................19
2.4.3.2
Compliance ....................................................................................................................................19
2.4.4
Analyses of efficacy endpoints.......................................................................................................19
2.4.4.1
Analysis of primary efficacy endpoint(s) ........................................................................................19
2.4.4.2
Analyses of secondary efficacy endpoints.....................................................................................22
2.4.4.3
Multiplicity issues ...........................................................................................................................22
2.4.4.4
Analyses of tertiary efficacy endpoints and other endpoints .........................................................23
2.4.5
Analyses of safety data..................................................................................................................23
2.4.5.1
Analyses of adverse events ...........................................................................................................24
2.4.5.2
Deaths............................................................................................................................................26
2.4.5.3
Analyses of laboratory variables....................................................................................................26
2.4.5.4
Analyses of vital sign variables ......................................................................................................26
2.4.6
Analyses of quality of life ...............................................................................................................26
2.5
DATA HANDLING CONVENTIONS ..............................................................................................26
2.5.1
General conventions ......................................................................................................................26
2.5.2
Data handling conventions for secondary efficacy variables.........................................................27
2.5.3
Missing data...................................................................................................................................27
2.5.4
Windows for time points.................................................................................................................29
2.5.5
Unscheduled visits .........................................................................................................................29
2.5.6
Pooling of centers for statistical analyses......................................................................................30
2.5.7
Statistical technical issues .............................................................................................................30
3
INTERIM ANALYSIS .....................................................................................................................31
4
DATABASE LOCK........................................................................................................................32
5
SOFTWARE DOCUMENTATION .................................................................................................33
6
REFERENCES...............................................................................................................................34
7
LIST OF APPENDICES.................................................................................................................35
APPENDIX A
SCHEDULE OF STUDY EVENTS.......................................................................................36
(electronic 
 
 
 
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Statistical Analysis Plan
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Page 4
APPENDIX B
SUMMARY OF STATISTICAL ANALYSES.........................................................................38
APPENDIX C
POTENTIALLY CLINICALLY SIGNIFICANT ABNORMALITIES CRITERIA ......................40
(electronic 
 
 
 
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Statistical Analysis Plan
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Page 5
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS
AE: 
adverse event
AESI: 
adverse event of special interest
ALP
alkaline phosphatase
ALT
alanine aminotransferase
ANCOVA: 
analysis of covariance
AST
aspartate aminotransferase
AT: 
all-treated
ATC
anatomic Therapeutic Chemical
COGA: 
clinical observer global assessment
eCRF: 
electronic case report form
EQ-5D: 
euroQol five dimensions
GEE: 
generalized estimating equation
GGT
gamma-glutamyl transpeptidase
HRQOL
Health-Related Quality of Life
IA: 
intra-articular
IMP: 
investigational medicinal product
IVRS: 
interactive voice response system
LOCF: 
last observation carry forward
MAR
missing at random
MedDRA
medical Dictionary for Regulatory Activities
mITT: 
modified intent-to-treat
NRS: 
numerical rating scale
OA: 
osteoarthritis
OC: 
observed case
PBS: 
phosphate buffered saline
PCSA: 
potentially clinically significant abnormality
PQ: 
patient questionnaire
PT: 
preferred term
PTGA: 
patient global assessment
SAE: 
serious adverse event
SAIR: 
severe acute inflammatory reaction
SAP: 
statistical analysis plan
SD: 
standard deviation
SOC: 
system-organ-class
TEAE: 
treatment emergent adverse event
WOMAC: 
western Ontario and McMaster Universities Osteoarthritis Index
(electronic 
 
 
 
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Statistical Analysis Plan
28-Jan-2019
GZ402662-EFC12723
Version number: 1
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Page 6
1
OVERVIEW AND INVESTIGATIONAL PLAN  
1.1
STUDY DESIGN AND RANDOMIZATION
This is a 26-week, multicenter, double-blind, randomized, placebo-controlled parallel group study
to evaluate the efficacy and safety of a single dose of 6 mL of hylan G-F 20 (Synvisc-One)
injected IA into the knee in Chinese patients with symptomatic OA of the knee.
A screening and wash-out period may last for up to 14 days, depending on the half-life of the
medications (please refer to Appendix C of the protocol), followed by an 8-day baseline period 
including the treatment day (Day 1). Overall, up to 21 days are allowed between signing informed 
consent (at screening visit) and the randomization (Day 1).The study observation period starts at
randomization and lasts until the end of the study. IMP or placebo will be injected IA into knee of
the randomized patients on Day 1. Randomized patients who had either IMP or placebo will be
invited for 7 post treatment observation visits, up to Week 26 (see Section 1.2).
The randomization ratio of hylan G-F 20: placebo is 1:1.
Approximately 422 patients (211 patients per treatment group) will be recruited and randomized.
1.2
OBJECTIVES
1.2.1
Primary objectives
The primary objective of this study is to evaluate the efficacy of a single 6-mL IA injection of 
Hylan G-F 20 measured by Western Ontario and McMaster Universities Osteoarthritis Index 
(WOMAC) Numerical Rating Scale (NRS) 3.1 A1 score (1), over 26 weeks, in Chinese patients
with symptomatic osteoarthritis (OA) of the knee.
1.2.2
Secondary objectives
The secondary objectives of this study are:

To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by 7-day 
average score of WOMAC A1 pain subscore in comparison to an IA placebo injection 
over 26 weeks.

To evaluate the efficacy of a single 6-mL IA injection of Hylan G-F 20 measured by 
WOMAC A, patient global assessment (PTGA) and clinical observer global assessment 
(COGA) in comparison to an IA placebo injection over 26 weeks.
(electronic 
 
 
 
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Statistical Analysis Plan
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Page 7

To evaluate the response rate of a single 6-mL IA injection of Hylan G-F 20 in comparison 
to an IA placebo injection over 26 weeks. Response is defined as WOMAC A1 ≥2-point 
improvement from baseline on NRS.

To evaluate the safety of a single 6-mL IA injection of Hylan G-F 20 in comparison to an 
IA placebo injection over 26 weeks.
1.2.3
Tertiary efficacy and other objectives
The tertiary and other objectives of this study are:

To evaluate changes from baseline at Week 4, 8, 12, 16, 20, and 26 measured by WOMAC 
A1, WOMAC A, B, C and total, as well as PTGA, COGA and 7-day average score of 
WOMAC A1 pain subscore, in comparison with IA placebo injection.

To evaluate the amount and days of permitted pain rescue medication use at Week 4, 8,
12, 16, 20, and 26 recorded by patient diary.

To explore changes in patient quality of life from baseline after a single 6-mL IA injection 
of Hylan G-F 20 treatment at Week 4, 8, 12, 16, 20 and 26 by using EuroQol five 
dimensions (EQ-5D) questionnaire.
1.3
DETERMINATION OF SAMPLE SIZE
The sample size calculations are based on the primary efficacy variable of WOMAC A1 over
26 weeks, with the following assumptions:
A common SD of 
 on the NRS scale

 (on the NRS scale) mean difference in treatment effect of Hylan G-F 20 on the
change from baseline in WOMAC A1 over 26 weeks, compared to placebo
A t-test at a 2-sided 5% significance level with 90% power
The estimated treatment effect and SD are based on the observed treatment effect and SD for the
WOMAC A1 over 26 weeks in US pivotal study (SOUND study) for a subgroup by excluding
patients with symptomatic OA of another lower limb joint. Based on the above assumptions,
211 patients per treatment group, thus 422 patients in total will be randomized for this study.
As the ANCOVA model will be used for primary analysis, the power should be somewhat higher
due to reduced estimate variability versus the t-test.
Calculations were made using nQuery Advisor 6.01.
(electronic 
 
 
 
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Statistical Analysis Plan
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Page 8
1.4
STUDY PLAN
The study consists a Screening period (Day -21 to -8, including necessary medication washout 
period), 8-day baseline (including the treatment day (Day 1)) evaluations and a 26-week follow-
up period. 
A screening and wash-out period may last for up to 14 days, depending on the half-life of the
medications (please refer to Appendix C), followed by an 8-day baseline period including the
treatment day (Day 1). Overall, up to 21 days are allowed between signing informed consent (at
screening visit) and the randomization (Day 1). In case eligibility criteria are not met, the patient 
may be re-screened and will follow the same procedure as described in the flow chart from 
screening visit to Day 1. A new patient number will be allocated. The study observation period 
starts at randomization and lasts until the end of the study. IMP or placebo will be injected IA into 
knee of the randomized patients on Day 1.
Approximately 422 patients are to be randomized in this study, in a 1:1 ratio, to receive either 
Hylan G-F20 or control (phosphate buffered saline) on Study Day 1 of the 26-week study period. 
Injection procedure details are given in protocol section 8. The patient and evaluator are blinded 
to investigative study treatment. 
All patients are to have 7 site visits (Week 1, 4, 8, 12, 16, 20, 26, see Appendix A) during the on 
treatment period. Assessments of OA symptoms (WOMAC, PTGA), COGA and assessments of 
safety are performed at baseline visit and at specified time points over the 26-week study period.
Acetaminophen for target knee OA pain (rescue medication) for causes other than target knee pain 
(eg, flu, headache, non-target joint pain) are permitted during the study (see protocol 
Section 8.8.3), but must not be taken within 48 hours prior to a study visit (ie, within 2 days of a 
site visit), so as to not interfere with any patient-rated assessments. If acetaminophen is taken 
within the 48 hours period above, then the study visit must be rescheduled within the time 
window specified in Appendix A in the SAP.
The end of the study is defined as the last patient last visit planned per protocol, including the
follow-up visit.
A schematic of the study design (protocol Figure 1) is copied here:
(electronic 
 
 
 
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Statistical Analysis Plan
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Page 9
1.5
MODIFICATIONS TO THE STATISTICAL SECTION OF THE PROTOCOL 
The protocol history table below gives the timing, rationale, and key details of major changes to 
the protocol statistical section.
(electronic 
 
 
 
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Statistical Analysis Plan
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Version number: 1
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Page 10
Table 1 - Protocol amendment statistical changes
Amendment  
Number
Date 
Approved
Rationale
Description of statistical changes
1.0(electronic 3.0)
17-Feb-2017
Pain study has lower probability of 
success in general. Analyses of 
newly added endpoints will better 
interpret the study outcomes.
Adding a secondary endpoint, difference 
between treatment groups in change from 
baseline over 26 weeks in 7-day average 
WOMAC A1; 
Adding tertiary efficacy endpoints, including 
the differences between treatment groups in:
• changes from baseline at Week 4, 8, 12, 
16, 20, and 26 in 7-day average WOMAC A1
• changes from baseline at Week 4, 8, 12, 
16, 20, and 26 measured by WOMAC A1, 
WOMAC A, B, C and total, as well as PTGA 
and COGA
• the amount and days of permitted pain 
rescue medication use at Week 4, 8, 12, 16, 
20, and 26.
and Quality of life variables include:
• changes of quality of life from baseline at 
Week 4, 8, 12, 16, 20, and
26 in EQ-5D scores.
1.6
STATISTICAL MODIFICATIONS MADE IN THE STATISTICAL ANALYSIS PLAN
Not applicable.
(electronic 
 
 
 
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Statistical Analysis Plan
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Page 11
2
STATISTICAL AND ANALYTICAL PROCEDURES
2.1
ANALYSIS ENDPOINTS
2.1.1
Demographic and baseline characteristics
The baseline value is generally defined as the last available value before randomization.
All baseline safety and efficacy parameters are presented along with the on-treatment summary 
statistics in the safety and efficacy sections (Section 2.4.5 and Section 2.4.4).
Demographic characteristics
Demographic variables are gender (Male, Female), age in years (quantitative and qualitative 
variable: 60 and >60 years), race (American Indian or Alaska Native, Asian, Black, Native 
Hawaiian or Other Pacific Islander, White, Unknown), baseline BMI. 
Medical or surgical history
Medical (or surgical) history includes information on the eCRF relating to any prior or existing 
medical conditions/surgical procedures involving the following categories: Infectious Diseases, 
Allergic, Metabolic/Endocrine/Nutritional, Haematopoietic, Musculoskeletal, Dermatological, 
Head, Ears, Eyes, Nose, and Throat (HEENT), Breasts, Respiratory, Cardiovascular, 
Gastrointestinal/Hepatic, Genitourinary/Renal, Neurological, and Psychiatric/Psychosocial.
The patient will be asked to provide a relevant medical history with specific dates. Those
conditions and/or procedures reported will be compared to the inclusion and exclusion criteria for
the study. Specific attention is paid to the patient’s previous history with respect to exclusionary
conditions, procedures, and surgeries.
This information will be coded using the version of Medical Dictionary for Regulatory Activities 
(MedDRA) currently in effect at Sanofi at the time of database lock.
Disease characteristics at baseline  
Specific disease history includes target knee (Right, Left), X-ray used as a diagnostic tool (yes, 
no), the Modified Kellgren-Lawrence Numerical Grading System (2) grade for the target knee
(grade 0, grade I, grade II, grade III and grade IV).
Vital signs 
Vital signs at baseline are temperature, heart rate, and systolic and diastolic blood pressure.
Any technical details related to computation, dates, and imputation for missing dates are described 
in Section 2.5. 
(electronic 
 
 
 
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2.1.2
Prior or concomitant medications
All medications will be coded using the World Health Organization-Drug Dictionary (WHO-DD) 
using the version currently in effect at Sanofi at the time of database lock.

Prior medications are those the patient used 26 weeks prior to first investigational 
medicinal product (IMP) injection.  Prior medications can be discontinued before first 
administration or can be ongoing during treatment phase.  

Concomitant medications are any treatments received by the patient concomitantly to the
IMP, from randomization to the end of treatment. A given medication can be classified 
both as a prior medication and as a concomitant medication.
Acetaminophen (rescue medication) are permitted for causes other than target knee OA pain
(eg, flu, headache, non- target joint pain) during the study, but must not be taken within 48 hours 
prior to a study visit, so as to not interfere with any patient-rated assessments. Information on 
acetaminophen will be captured in the eCRF and should include the date, medication strength, 
dose (eg, number of tablets per day), dosage form, and whether or not it was taken for target knee 
OA pain. On an as-needed basis in a tiered manner, the following therapies will be allowed as 
rescue medication: 1) Acetaminophen (500 mg), 2) Acetaminophen (325 mg)/oxycodone (5 mg), 
or 3) Acetaminophen (325 mg)/tramadol (37.5 mg).
Any technical details related to computation, dates, imputation for missing dates are described in 
Section 2.5.
2.1.3
Efficacy endpoints
The baseline value for efficacy endpoints is defined as the last available value prior to the IMP 
administration or last available value on or before the date of randomization if not treated, unless 
otherwise specified.
WOMAC scores 
The WOMAC NRS 3.1 questionnaire is a self-administered, health status measure used to probe
symptoms of pain (WOMAC A), stiffness (WOMAC B), and function (WOMAC C) in patients 
with OA of the knee (1, 3). The questionnaire consists of 24 questions relating to the patient’s 
assessment of his/her target joint pain (5 questions), stiffness (2 questions), and physical function 
(17 questions). An 11-point NRS ranging from 0 (None) to 10 (Extreme) will be used to capture
the patient’s response to each of the questions. All responses will be recorded directly on the
paper patient questionnaire (PQ), and the PQ will serve as source documentation. The patient was
asked to check the box that indicated his/her amount of target joint pain, amount of stiffness, and 
degree of difficulty completing tasks within the past 48 hours.
The WOMAC A consists of 5 questions assessing pain symptoms while walking, using stairs, at
night while in bed, sitting or lying, and standing.
The WOMAC A1 is a single question within the WOMAC A that specifically assesses target knee 
pain while walking on a flat surface.
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The WOMAC B consists of 2 questions assessing severity of stiffness that occurs after a period of 
inactivity later that same day.
The WOMAC C consists of 17 questions assessing physical function while performing the
following activities: stair rise, rise from sitting, standing, bending, walking, getting in/out of a car, 
putting on/taking off socks, rising from bed, lying in bed, getting in/out of bath, sitting, getting 
on/off toilet, heavy household duties, and light household duties.
The WOMAC total score is computed as the sum of the available components of the 3 subscores: 
WOMAC A, WOMAC B and WOMAC C. The raw total WOMAC score ranges from 0 to 240, 
since the sums for the components of the 3 subscores range from 0 to 50 for the WOMAC A, 0 to 
20 for the WOMAC B, and 0 to 170 for the WOMAC C. The total WOMAC score will be set to
missing if any of the WOMAC subscores are set to missing as defined above. The raw total 
WOMAC score will be standardized to the 0 to 10 scale by dividing by 24.
Patient Global Self-Assessment (PTGA)
The patient’s global self-assessment of target knee OA condition is the response on an 11-point
NRS (0 = best possible to 10 = worst possible) to the question “Considering all the ways that the
arthritis of your target knee affects you, select one response below for how you are doing at the
present time.” The patient’s response will be recorded directly on the PQ, and the PQ will serve as
the source documentation.
Clinical Observer Global Assessment (COGA)
The physician performs a global assessment of the patient’s target knee OA using the 11-point 
NRS pain intensity rating scale (0 = best possible to 10 = worst possible) in response to the 
question “Considering all the ways that the arthritis of the patient’s target knee affects him/her, 
select one response below for how you feel the patient is doing at the present time.” The same 
physician will complete this assessment for all patients at a site and record in the eCRF and this 
will serve as the source documentation.
2.1.3.1
Primary efficacy endpoint(s)
The primary efficacy endpoint is change from baseline in WOMAC A1 over 26 weeks for hylan 
G-F 20 compared to placebo.
2.1.3.2
Secondary efficacy endpoint(s)
Secondary efficacy endpoints include the differences between treatment groups in:

Change from baseline over 26 weeks in 7-day average walking pain score (measured by
daily WOMAC A1, 7-day average WOMAC A1), WOMAC A, B, C and total, as well as 
PTGA, and COGA

Percentages of positive responders over 26 weeks, where response is defined as a ≥2-point
improvement from baseline in the WOMAC A1 NRS
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2.1.4
Safety endpoints
The safety analysis will be based on the reported adverse events and other safety information, 
including vital signs. 
Observation period 
The observation period will be divided into 2 periods:

The pre-treatment period is defined as the time between when the patients give informed 
consent and the injection of IMP.

The on-treatment period is defined as the time from the injection of the IMP up to
Week 26 follow up visit.
The treatment-emergent adverse event period will only include the on-treatment period.
2.1.4.1
Adverse events variables
Adverse event observation period 

Pretreatment adverse events are adverse events that developed or worsened or became 
serious during the pretreatment period

Treatment-emergent adverse events are adverse events that developed or worsened or 
became serious during the treatment-emergent adverse event period
All adverse events (including serious adverse events) will be coded to a lower-level term (LLT), 
preferred term (PT), high-level term (HLT), high-level group term (HLGT), and associated 
primary system organ class (SOC) using the version of Medical Dictionary for Regulatory 
Activities (MedDRA) currently in effect at Sanofi at the time of database lock.
Adverse event of special interest (AESI)

Anaphylaxis

Foreign Body Reaction

Pseudosepsis

Severe acute inflammatory reaction (SAIR)

Joint infection

Injection site allergy

Drug allergy

Pregnancy
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2.1.4.2
Deaths
The deaths observation period are per the observation periods defined above.

Death on-study: deaths occurring during the treatment-emergent adverse event period 
2.1.4.3
Laboratory safety variables
Not applicable.
2.1.4.4
Vital signs variables
Vital signs include:  temperature, heart rate, and systolic and diastolic blood pressure.
2.1.5
Tertiary efficacy endpoints and other endpoint
2.1.5.1
Tertiary efficacy endpoints
Tertiary efficacy endpoints include the differences between treatment groups in:

Changes from baseline at Week 4, 8, 12, 16, 20, and 26 in 7-day average WOMAC A1

Changes from baseline at Week 4, 8, 12, 16, 20, and 26 measured by WOMAC A1, 
WOMAC A, B, C and total, as well as PTGA and COGA

The amount and days of permitted pain rescue medication use at Week 4, 8, 12, 16, 20, 
and 26.
2.1.5.2
Quality of life variables
Changes of quality of life from baseline at Week 4, 8, 12, 16, 20, and 26 in EQ-5D scores.
Patients’ health status will be assessed using the EQ-5D-5L questionnaire which includes 5 levels 
of severity in each of the five dimensions: no problems, slight problems, moderate problems, 
severe problems, and extreme problems (4, 5).
2.2
DISPOSITION OF PATIENTS
This section describes patient disposition for both patient study status and the patient analysis 
populations.
Screened patients are defined as any patients who met the inclusion criteria and signed the 
informed consent.
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Randomized patients consist of all patients with a signed informed consent form who have had a 
treatment kit number allocated and recorded in the IVRS/IWRS database, and regardless of 
whether the treatment kit was used or not.
For patient study status, the total number of patients in each of the following categories will be 
presented in the clinical study report using a flowchart diagram or summary table:

Screened patients

Screen failure patients and reasons for screen failure

nonrandomized but treated patients

Randomized patients

Randomized but not treated patients and reason for not being treated

Randomized and treated patients

Patients who complete the 26-week on treatment period as per protocol

Patients who discontinued study participation by main reason for  study discontinuation

Status at last study contact
For all categories of patients (except for the screened and nonrandomized categories) percentages 
will be calculated using the number of randomized patients as the denominator divided by the 
number of exposed patients.  Reasons for study discontinuation will be supplied in tables giving 
numbers and percentages by treatment group. 
A patient is considered lost to follow-up at the end of the study if he/she is not assessed at the last 
protocol planned visit and if the time from the last successful contact to the last protocol planned 
visit is greater than 7 days.
All critical or major deviations potentially impacting efficacy analyses, randomization, and 
drug-dispensing irregularities, and other major or critical deviations will be summarized in tables 
giving numbers and percentages of deviations by treatment group.
Additionally, the analysis populations for safety and efficacy will be summarized in a table by 
number of patients on the randomized population.

Efficacy population: modified intent-to-treat (mITT) population

Safety population: all-treated population
2.2.1
Randomization and drug dispensing irregularities
Randomization and drug-dispensing irregularities occur whenever:
1. A randomization is not in accordance with the protocol-defined randomization method, 
such as a) an ineligible patient is randomized, b) a patient is randomized twice.
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2. A patient is dispensed an IMP kit not allocated by the protocol-defined randomization, 
such as a) a patient is dispensed a different treatment kit than as randomized (which may 
or may not contain the correct-as-randomized IMP), or b) a nonrandomized patient is 
treated with IMP reserved for randomized patients.
Randomization and drug-dispensing irregularities will be monitored throughout the study and 
reviewed on an ongoing basis. 
All randomization and drug-dispensing irregularities will be documented in the clinical study 
report.  If the number of irregularities is large enough to make a tabular summary useful, the 
irregularities will be categorized and summarized among randomized patients (number and 
percentages). Nonrandomized, treated patients will be described separately. 
2.3
ANALYSIS POPULATIONS
Patients treated without being randomized will not be considered randomized and will not be 
included in any efficacy population.  
The randomized population includes any patient who has been allocated to a randomized 
treatment regardless of whether the treatment kit was used.
For any patient randomized more than once, only the data associated with the first randomization 
will be used in any analysis population. The safety experience associated with any later 
randomization will be assessed separately.
The safety experience of patients treated and not randomized will be reported separately, and 
these patients will not be in the safety population.
2.3.1
Efficacy populations
2.3.1.1
Modified intent-to-treat population
The modified intent-to-treat population: mITT population contains all randomized and treated 
patients, as randomized. Patients will be analyzed in the treatment group to which they are 
randomized.
The mITT population is the primary analysis population and will be used for the analyses of all 
efficacy variables.
2.3.2
Safety population
The safety population is defined as: 

Randomized population who actually received at least 1 injection or part of an injection of 
Hylan G-F 20 or placebo. It is used for safety analysis, where observations will be 
summarized based on the treatment actually received
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In addition: 

Nonrandomized but treated patients will not be part of the safety population; however, 
their safety data will be presented separately

Randomized patients for whom it is unclear whether they took the IMP will be included in 
the safety population as randomized

For patients receiving randomized more than once, the safety experience associated with 
any later randomization will be assessed separately. 
2.3.3
Other analysis population 
None.
2.4
STATISTICAL METHODS
Continuous data will be summarized using the number of available data, mean, standard 
deviation (SD), median, minimum, and maximum for each treatment group. Categorical and 
ordinal data will be summarized using the number and percentage of patients in each treatment 
group. Missing data will not be categorized in the summaries.
2.4.1
Demographics and baseline characteristics
Parameters will be summarized on the randomized population analyzed in the treatment group to 
which they were randomized. Analyses for the safety population will be included in the 
appendices if the size of the safety population is different (>10%) from the size of that in the 
primary analysis population for any treatment group.
Parameters described in Section 2.1.1 will be summarized by treatment group and overall 
treatment groups using descriptive statistics. 
Medical or surgical history as recorded on the eCRF will be summarized by SOC and PT.
P-values on demographic and baseline characteristic data will not be calculated. 
2.4.2 Prior or concomitant medications
The prior and concomitant medications will be presented on the safety population. 
Medications will be summarized by treatment group according to the WHO-DD dictionary, 
considering the first digit of the anatomic category (ATC) class (anatomic category) and the first 
3 digits of the ATC class (therapeutic category). All ATC codes corresponding to a medication 
will be summarized, and patients will be counted once in each ATC category (anatomic or 
therapeutic) linked to the medication. Therefore patients may be counted several time for the same 
medication. 
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The table for prior medications will be sorted by decreasing frequency of ATC followed by all 
other therapeutic classes based on the overall incidence across treatment groups. In case of equal 
frequency regarding ATCs (anatomic or therapeutic categories), alphabetical order will be used.
The tables for concomitant medications will be sorted by decreasing frequency of ATC followed 
by all other therapeutic classes based on the incidence in the treatment group. In case of equal 
frequency regarding ATCs (anatomic or therapeutic categories), alphabetical order will be used. 
2.4.3
Extent of investigational medicinal product exposure and compliance 
The extent of IMP exposure will be assessed and summarized by actual treatment within the 
safety population (Section 2.3.2).
2.4.3.1
Extent of investigational medicinal product exposure
The extent of IMP exposure will be assessed by actual dose information.
Dose information will be summarized descriptively (number, mean, SD, median, minimum and 
maximum) for the volume administered of the IMP by treatment group.
Fluid or effusion withdrawn will also be summarized in a similar manner as dose information.
2.4.3.2
Compliance
No compliance analysis will be done for this study. 
2.4.4
Analyses of efficacy endpoints
2.4.4.1
Analysis of primary efficacy endpoint(s)
The statistical test for the primary efficacy endpoint, the mean change from baseline measure of
pain relief (WOMAC A1) between Hylan G-F 20 and placebo over 26 weeks, will be 2-sided at α
level of 0.05.
For the primary efficacy endpoint, the following null hypothesis and alternative will be tested:   
H0: Hylan G-F 20 is not superior to placebo
H1: Hylan G-F 20 is superior to placebo
The primary effectiveness analysis will be performed on the mITT population and will be based
on repeated-measures Analysis of Covariance (ANCOVA) that will be used to test for differences
in treatment efficacy, as quantified by the change from baseline in WOMAC A1 over 26 weeks
between Hylan G-F 20 and placebo. The repeated measures ANCOVA model is equivalent to
mixed model for repeated measures (MMRM) and will include terms for treatment, site, visit and 
visit-by-treatment interaction, as well as the baseline WOMAC A1 score as a covariate.
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The difference between Hylan G-F 20 group and placebo group and its corresponding 95%
confidence interval will be estimated within the framework of ANCOVA. An unstructured 
variance-covariance structure will be used to model the within-patient errors. If this model fails to 
converge, the following structures will be tested in this order: Toeplitz (equal variances and a 
separate correlation for each level of separation between the time points), AR (1) (first-order 
autoregressive, equal variances and exponentially decreasing correlations), CS (compound 
symmetry, equal variances and equal pairwise correlations across fixed time points). The first 
(co)variance structure yielding convergence will be used as the primary analysis.
The Kenward-Roger approximation will be used to estimate denominator degrees of freedom. 
Outcomes between patients are assumed to be independent. The primary comparison will be the 
contrast between Hylan G-F20 and control over 26 weeks. An example of the SAS code is 
provided below (note time is modeled with the visit variable):
SAS Display 1 Code for Continuous Endpoints
proc mixed data = data method = ml;
class patid randgrp site visit;
model y_chg = site baseline randgrp visit visit*randgrp / ddfm=kr;
repeated visit / type = un subject = patid;
lsmeans randgrp randgrp*visit / cl diff at baseline= baseline;
run;
where:
randgrp = Hylan G-F20, control
site    = site number
visit   = numerical visit weeks (4,8,12,16,20,26)
baseline= patient’s baseline WOMAC A1 score
y_chg   = change from baseline WOMAC A1 value (WOMAC A1 value at post-baseline 
visit assessment minus the baseline value)
TYPE =
UN  = unstructured covariance
CS  = compound symmetry covariance
AR(1)= first-order autoregressive covariance
TOEP = Toeplitz covariance
Subgroup analysis 
Descriptive analyses will be performed on the primary efficacy endpoint to summarize the 
treatment effects across subgroups for the following baseline characteristics as needed and will be 
considered as exploratory.

Age groups (60, >60 years)

BMI category (<=25, >25)

Baseline WOMAC A1 score (5, 6-7, 8)
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Sensitivity analysis 
Sensitivity analyses will be performed using multiple imputation (MI) methods based on pattern 
mixture models (6) as appropriate.
First, a repeated measures Normal model will be fitted to the data using a Bayesian approach, with 
non-informative priors for the mean and variance-covariance matrix to provide a joint posterior 
for the parameters in the model. The repeated measures Normal model will include separate mean 
profiles for each treatment group and the same covariates as those in the primary analysis. 
Independent samples will then be drawn from the posterior distributions for the mean and 
variance-covariance matrix to provide inputs into an imputation model.
For each subject with missing data, these sampled values of the parameters for mean vectors and 
the variance-covariance matrices specify a joint distribution for their observed and unobserved 
outcome data. The post-withdrawal part of each pattern-specific distribution will be modelled 
using the approaches discussed below.
Based on this imputation model, a single set of data will be sampled for the missing data based on 
the distribution for the subject’s missing data conditional upon their observed data.
Each imputed data set will then be analyzed using the same repeated measures analysis of 
ANCOVA and resulting treatment differences over 26 weeks and their standard errors will then be 
combined to produce valid statistical inference based on t-tests using the SAS PROC 
MIANALYZE. Least-squares mean change from baseline over 26 weeks for each treatment group 
will be calculated and displayed with their associated standard errors. Estimated treatment 
differences along with corresponding 95% confidence intervals and p-values will also be 
presented. These analyses will also be performed at each scheduled post-base visit.
The post-withdrawal part of each pattern-specific distribution will be modelled using the 
following approaches:

Missing at Random (MAR) Approach: The means and variance-covariances following
withdrawal are chosen to reflect the subject’s own treatment group. This approach will
provide similar results to using a mixed effects model where the unstructured covariance
matrix is estimated separately for each treatment group.

Copy Reference (CR) Approach: The whole distribution of Hylan G-F20 group even prior
to withdrawal is assumed to be the same as the control group. This mimics the case where
those withdrawing are in effect non-responders. If a patient on Hylan G-F20 is above the
control group mean then this positive residual will feed through into subsequent
observations, to a degree determined by the correlation in the control group. The patient’s
profile will slowly decay back towards the mean for the control group at later visits. For
the control group, this is equivalent to the MAR approach above.
It is important to note that the CR approach is conservative and constructed to attenuate the 
treatment difference estimated from the primary analysis.
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2.4.4.2
Analyses of secondary efficacy endpoints
As with the primary effectiveness analysis, the secondary effectiveness analyses will be
performed on the mITT population as well. 
For the analysis of the change from baseline in 7-day average WOMAC A1, WOMAC A, PTGA, 
and COGA, repeated-measures ANCOVA will be used as described in the description of the 
primary effectiveness analysis.
For the analysis of WOMAC A1 responders (≥2 point improvement on NRS Scale) generalized
estimating equations (GEE) modeling will be used. Each responder (yes/no) endpoint evaluated at 
multiple post-baseline visits will be analyzed using GEE for binary outcomes. A GEE model will 
be fitted to the responder data and will include terms for baseline measure, site, visit, treatment 
group and a visit-by-treatment group interaction. Hypothesis testing will be performed using least 
squares means based on the linear predictor of the model.
For the analysis of the percentages of positive responders, patients who discontinued the study
prior to the Week 26 assessment due to either target knee-related AEs or due to lack of efficacy
were classified as non-responders in the efficacy analysis. Patients who discontinued the study for 
other reasons had their responder status imputed using the LOCF method. The LOCF was used for 
all responder analyses, but not for the analysis of other parameters. No replacement on any 
missing or invalid data was made for the safety analyses.
No sensitivity analyses are planned for secondary efficacy endpoints in this study.
2.4.4.3
Multiplicity issues
The overall Type I Error will be set at 5%. The primary effectiveness endpoint will be tested at
the 5% significance level.
The analyses of secondary effectiveness variables will be interpreted according to the Hochberg
Step-Up (7) Procedure with the overall alpha set at the 0.05 level. The procedure will be
implemented as follows:
The observed p-values will be sorted in descending order p1 >…>pm.
Term
Interpretation
Value 
i
The current positioning the evaluation order
m
The total number of comparisons
5
q
The overall level of type I error rate for the family of tests
0.05
pi
An individual observed p-value in the ith position
qi
Significance level of the ith comparison
For each evaluation i the largest p-value remaining in the set to be evaluated pi is compared to the
significance level for that comparison (q/i). If pi is less than the significance level, it and all other
p-values remaining in the set are declared statistically significant and the evaluation process stops.
If this condition is not met, then the current pi is declared, “not statistically significant” and the
remaining set of observed p-values is evaluated at the next value of “i”. If the last p-value (pm)
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fails at the level of q/m, then all comparisons are declared to be not statistically significant. With
5 secondary endpoints, the evaluation will be conducted according to the following table:
i
qi less than
interpretation
1
0.0500
All five tests declared significant
2
0.0250
P2, p3, p4 and p5 declared significant 
3
0.0167
P3, p4 and p5 declared significant
4
0.0125
P4 and p5 declared significant
5
0.0100
P5 declared significant
2.4.4.4
Analyses of tertiary efficacy endpoints and other endpoints
The analyses of tertiary efficacy endpoints and other endpoints will be presented with unadjusted 
p-values and considered exploratory. As with the primary effectiveness analysis, the tertiary 
effectiveness analyses and analyses of other endpoints will be performed on the mITT population 
as well. 
For the analyses of the change from baseline in WOMAC A1, 7-day average WOMAC A1, 
WOMAC A, PTGA and COGA at Week 4, 8, 12, 16, 20, and the change from baseline in
WOMAC B, C and total and quality of life at Week 4, 8, 12, 16, 20, 26, the same repeated-
measures ANCOVA model as described in the primary analysis will be used. The changes from 
baseline to each visit for each parameter will be calculated. Means and adjust means of each 
treatment group will be provided, as well as adjusted mean and associated two-sided 95% CI of 
the difference between treatment groups.
For the change from baseline in the amount and days of permitted pain rescue medication at each 
post-baseline visit, the Wilcoxon Mann Whitney test will be performed.
2.4.5
Analyses of safety data
The summary of safety results will be presented by treatment groups.
General common rules
All safety analyses will be performed on the safety population as defined in Section 2.3.2, unless 
otherwise specified, using the following common rules:

Safety data in patients who do not belong to the safety population (eg, exposed but not 
randomized) will be listed separately

The baseline value is defined generally as the last available value before randomization.

The potentially clinically significant abnormality (PCSA) values are defined as abnormal 
values considered medically important by the Sponsor according to predefined 
criteria/thresholds based on literature review and defined by the Sponsor for clinical 
laboratory tests and vital signs.

PCSA criteria will determine which patients had at least 1 PCSA during the treatment-
emergent adverse event period, taking into account all evaluations performed during the 
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treatment-emergent adverse event period, including nonscheduled or repeated evaluations.  
The number of all such patients will be the numerator for the on-treatment PCSA 
percentage

The treatment-emergent PCSA denominator by group for a given parameter will be based 
on the number of patients assessed for that given parameter in the treatment-emergent 
adverse event period by treatment group on the safety population.

For quantitative safety parameters based on reading measurements, descriptive statistics 
will be used to summarize results and change from baseline values by visit and treatment 
group.

The analysis of the safety variables will be essentially descriptive and no systematic
testing is planned. Relative risks versus placebo and their 95% confidence intervals may 
be provided, if relevant

selected safety analyses will be summarized by age, gender subgroups, and any pertinent 
subgroups as appropriate
2.4.5.1
Analyses of adverse events
Generalities
The primary focus of adverse event reporting will be on treatment-emergent adverse events. Pre-
treatment adverse events will be described separately. 
If an adverse event date/time of onset (occurrence, worsening, or becoming serious) is incomplete, 
an imputation algorithm will be used to classify the adverse event as pretreatment or treatment-
emergent. The algorithm for imputing date/time of onset will be conservative and will classify an 
adverse event as treatment emergent unless there is definitive information to determine it is pre-
treatment. Details on classification of adverse events with missing or partial onset dates are 
provided in Section 2.5.3.
Adverse event incidence tables will present by SOC and PT, sorted in alphabetical order for each 
treatment group, the number (n) and percentage (%) of patients experiencing an adverse event.  
Multiple occurrences of the same event in the same patient will be counted only once in the tables 
within a treatment phase. The denominator for computation of percentages is the safety 
population within each treatment group.
Sorting within tables ensures the same presentation for the set of all adverse events within the 
observation period (pretreatment and treatment-emergent).  For that purpose, the table of all 
treatment-emergent adverse events presented by SOC and PT sorted by the internationally agreed 
SOC order and decreasing frequency of PTs within SOCs will define the presentation order for all 
other tables unless otherwise specified. Sorting will be based on results for the experimental 
treatment arm. 
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Analysis of all treatment-emergent adverse events
The following treatment-emergent adverse event summaries will be generated for the safety 
population.

Overview of treatment-emergent adverse events, summarizing number (%) of patients 
with any
-
Treatment-emergent adverse event
-
Adverse event of special interest
-
Serious treatment-emergent adverse event
-
Treatment-emergent adverse event leading to death
-
Treatment-emergent adverse event leading to permanent study discontinuation

All treatment-emergent adverse events by primary SOC and PT, showing the number (%) 
of patients with at least 1 treatment-emergent adverse event, sorted by the internationally 
agreed SOC order and by decreasing incidence of PTs within each SOC. This sorting 
order will be applied to all other tables, unless otherwise specified

All treatment-emergent adverse events regardless of relationship and related by primary 
SOC, and PT, showing the number (%) of patients with at least 1 treatment-emergent 
adverse event, sorted by the internationally agreed SOC order.  The PT level will be 
presented in alphabetical order

All treatment-emergent adverse events by maximal severity, presented by primary SOC 
and PT, showing the number (%) of patients with at least 1 treatment-emergent adverse 
event by severity (ie, mild, moderate, or severe), sorted by the sorting order defined above
Analysis of all treatment emergent serious adverse event(s)

All treatment-emergent serious adverse events by primary SOC, and PT, showing the 
number (%) of patients with at least 1 serious treatment-emergent adverse event, sorted by
the internationally agreed SOC order. The PT level  will be presented in alphabetical
order

All treatment-emergent serious adverse events regardless of relationship and related to 
IMP, by primary SOC,  and PT, showing the number (%) of patients with at least 
1 treatment-emergent serious adverse event, sorted by the internationally agreed SOC 
order. The PT levels will be presented in alphabetical order
Analysis of all treatment-emergent adverse event(s) leading to study discontinuation

All treatment-emergent adverse events leading to study discontinuation, by primary SOC  
and PT, showing the number (%) of patients sorted by the internationally agreed SOC 
order. The PT level will be presented in alphabetical order

PTs within each SMQ
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Analysis of adverse event of special interest

All adverse event of special interest by primary SOC and PT, showing the number (%) of 
patients sorted by the internationally agreed SOC order and decreasing incidence of PTs 
within each SOC
Analysis of pretreatment adverse events 

All pretreatment adverse events by primary SOC and PT, showing the number (%) of 
patients sorted by the internationally agreed SOC order and decreasing incidence of PTs 
within each SOC
2.4.5.2
Deaths
Any adverse events leading to death will be presented as a listing, indicating the study period 
(pretreatment or treatment-emergency period).
2.4.5.3
Analyses of laboratory variables 
Not applicable.
2.4.5.4
Analyses of vital sign variables
The summary statistics (including number, mean, median, standard deviation, minimum and 
maximum) of all vital signs variables (central laboratory values and changes from baseline) will 
be calculated for each visit or study assessment (baseline, each post-baseline time point) by 
treatment group.  
2.4.6
Analyses of quality of life
The analyses of quality of has been described in Section 2.4.4.4.
2.5
DATA HANDLING CONVENTIONS
2.5.1
General conventions
The following formulas will be used for computation of parameters.
Demographic formulas
Age in years = integer part of ((date of informed consent - date of birth)/365.25)
Vital signs formulas
BMI = weight in kilograms divided by height in meters squared
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Prior or concomitant medications and therapeutic procedures derivation
Prior medications are those the patient used 26 weeks prior to first investigational medicinal 
product (IMP) injection.  Prior medications can be discontinued before first administration or can 
be ongoing during treatment phase.
Concomitant medications are any treatments received by the patient concomitantly to the IMP, 
from randomization to the end of treatment. 
A given medication can be classified both as a prior medication and as a concomitant medication.
2.5.2
Data handling conventions for secondary efficacy variables
For 7-day average WOMAC A1, the baseline value is defined as the average of the WOMAC A1 
scores recorded 7 days prior to the first IMP administration (WOMAC A1 score recorded on Day 
1 included). The 7-day average WOMAC A1 will be set as missing if 3 or more of the 7 WOMAC 
A1 scores were missing. 
The analyses for change from baseline over 26 weeks for 7-day average WOMAC A1, WOMAC 
A, PTGA, and COGA are similar to the analyses for the primary effectiveness endpoint (SAP
Section 2.4.4.1).
2.5.3
Missing data
For the analysis of the percentages of positive responders, patients who discontinue the study 
prior to the Week 26 assessment due to either target knee-related AEs or due to lack of 
effectiveness will be classified as non-responders (no=0) in the effectiveness analysis. Patients 
who discontinue the study for other reasons will have the responder status imputed using the 
LOCF method as follows: If a patient is a responder (yes=1) or a non-responder (no=0) at a given 
visit, but at the next visit the patient does not have the data necessary to determine responder/non-
responder status, then at the second visit the individual values from a previous visit will not be 
carried forward but the responder/non-responder determination of the previous visit will be 
carried forward. Small amounts of intermediate missing data will also be handled by this LOCF 
method.
For categorical variables, patients with missing data are not included in calculations of 
percentages unless otherwise specified. When relevant, the number of patients with missing data 
is presented.
Handling of medication missing/partial dates
No imputation of medication start/end dates or times will be performed. If a medication date or 
time is missing or partially missing and it cannot be determined whether it was taken prior or 
concomitantly, it will be considered a prior, concomitant.
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Handling of adverse events with missing or partial date/time of onset
Missing or partial adverse event onset dates and times will be imputed so that if the partial 
adverse event onset date/time information does not indicate that the adverse event started prior to 
treatment or after the treatment-emergent adverse event period, the adverse event will be 
classified as treatment-emergent.
TEAEs are events with start dates on or after the date of injection. If the onset date of the AE is
partially or completely missing and the stop date of the AE does not indicate that it occurred prior 
to the injection, then the determination of treatment-emergent status will be based on the
following:
If the adverse event start year is after the year of the injection date, then the AE is
treatment emergent; else,
If the adverse event start year is the same as the year of the injection date and
-
the start month is missing, then the AE is treatment emergent; else if
-
the start month is present and is the same or after the month of the injection, then the 
AE is treatment-emergent; else,
If the start date is completely missing, then the AE is treatment-emergent.
No imputation of adverse event end dates/times will be performed.  These data imputations are for 
categorization purpose only and will not be used in listings.
Handling of adverse events when date and time of investigational medicinal product 
administration is missing
When the date and time of the injection is missing, all adverse events that occurred on or after the 
day of randomization should be considered as treatment-emergent adverse events.
Handling of missing assessment of relationship of adverse events to investigational medicinal 
product 
If the assessment of the relationship to IMP is missing, then the relationship to IMP has to be 
assumed and the adverse event considered as such in the frequency tables of possibly related 
adverse events, but no imputation should be done at the data level.
Handling of missing severity of adverse events
If the severity is missing for 1 of the treatment-emergent occurrences of an adverse event, the 
maximal severity on the remaining occurrences will be considered.  If the severity is missing for 
all the occurrences, a “missing” category will be added in the summary table.
Handling of potentially clinically significant abnormalities
Not applicable.
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2.5.4
Windows for time points
The time window for a given visit is defined in the protocol Schedule of Events, included in SAP
Appendix A.
The statistical analysis visit windows (see SAP Section 2.5.5 for unscheduled visits) are defined
below:
Visit 
number
Scheduled visit
Scheduled Visit Window, 
in Study days
Analysis Visit Window, 
in Study days
1
Screening
Study Day -21 to -8
-21 to -8
2
Baseline
Study Day -7 to 1
-7 to 1
3
Randomization
Study Day 1
1
4
Week 1
Study Day 7 4 days
2 to 17
5
Week 4
Study Day 28 4 days
18 to 42
6
Week 8
Study Day 56 7 days
43 to 72
7
Week 12
Study Day 84 7 days
73 to 96
8
Week 16
Study Day 112 7 days
97 to 126
9
Week 20
Study Day 140 7 days
127 to 161
10
Week 26
Study Day 182 7 days
162 to 196
If multiple valid values of a variable exist within an analysis window, the nearest one from the 
targeted study day will be selected. If the difference is a tie, the value after the targeted study day 
will be used. If multiple valid values of a variable exist within the same day, the first value of the 
day will be selected when time is available, or the scheduled visit will be selected.
2.5.5
Unscheduled visits
Unscheduled visit measurements of laboratory data, vital signs will not be included in the by-visit 
summaries, but will be used for computation of baseline.
Unscheduled and early withdrawal visit assessments for effectiveness measures will be assigned
to the nearest scheduled visit using the windowing scheme defined in SAP Section 2.5.4.
If only one record is within an analysis visit window, the data from that record will be used in the
summary statistics and by visit analyses. If more than one record is within the same analysis visit
window, the following rules will be applied:
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
If one record from regularly scheduled visit and one or more records from unscheduled visits 
fall in the same analysis visit window, then the record from the regularly scheduled visit will 
be used.

If one record from regularly scheduled visit and an early withdrawal visit fall in the same
analysis visit window, then the record from the early withdrawal visit will be used in the
current analysis visit and the regularly scheduled visit will not be used.

If no regularly scheduled visit and more than one record from unscheduled visits fall in the 
same analysis visit window, if there is an early withdrawal visit then the early withdrawal 
visit will be used; otherwise the unscheduled visit closest to the middle of the interval will be 
used.
2.5.6
Pooling of centers for statistical analyses
Not applicable.
2.5.7
Statistical technical issues
Not applicable.
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3
INTERIM ANALYSIS
No interim analysis is planned for this study.
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4
DATABASE LOCK
The database is planned to be locked at 4 weeks after last patient last visit.
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5
SOFTWARE DOCUMENTATION
All summaries and statistical analyses will be generated using SAS version 9.4 or higher.
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6
REFERENCES
1.
Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of 
WOMAC: A health status instrument for measuring clinically important patient relevant 
outcomes to anti-rheumatic drug therapy in patients with osteoarthritis of the hip or knee. J 
Rheumatol. 1988;15(12):1833-40.
2.
Kellgren JH, Lawrence JS. Radiological assessment of osteoarthritis. Ann Rheum Dis. 
1957;16(4):494-502.
3.
Bellamy N. WOMAC Osteoarthritis Index, A User’s Guide. 2002.
4.
Herdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, et al. Development and 
preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 
2011;20(10):1727-36.
5.
Reenen, V. M., Janssen, B. (2015). EQ-5D-5L User guide. Basic information on how to use 
the EQ-5D-5L instrument. EuroQol Group.
6.
Little RJA. Pattern-Mixture Models for Multivariate Incomplete Data. Journal of American 
Statistical Association. 1993;88(421):125-34.
7.
Hochberg Y. A sharper Bonferroni procedure for multiple tests of significance. 
Biometrika.1988;75(4):800-2.
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7
LIST OF APPENDICES
Appendix A:
Schedule of Study Events
Appendix B:
Summary of statistical analyses
Appendix C:
Potentially clinically significant abnormalities criteria
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Appendix A
Schedule of Study Events
Screening 
and
Washout
Baseline
(Treatment on Day 
1)
Follow-up
VISIT
1
2
3
4
5
6
7
8
9
DAY
Day -21 to 
Day -8a
Day -7 
to Day -
1
Day 1
Week 1
(±4 
days)
Week 4
(±4 
days)
Week 8
(±7 days)
Week 12
(±7 days)
Week 16
(±7 days)
Week 20
(±7 days)
Week 26b
(±7 days)
Informed Consentc
X
Inclusion Criteria & 
Exclusion criteria
X
X
Randomization 
X
Patient demography & 
Baseline Characteristics
X
Height & Weight  
X
Vital Signs
X
X
X
Medical History
X
Physical examinationd
X
X
Liver function test and 
biochemistrye
X
Urinary Pregnancy Testf
X
X
Radiograph
Xg
WOMAC (NRS)
X
X
X
X
X
X
X
X
PTGA
X
X
X
X
X
X
X
COGAh
X
X
X
X
X
X
X
EQ-5D
X
X
X
X
X
X
X
Prohibited Medication 
Washouti
X
Administration of IMP
X
Withhold Intake of 
Permitted Pain 
Medications for 48 Hours
X
X
X
X
X
X
X
X
Paper diary 
dispensation& training
X
Paper diary collection 
(reviewed at
each on-site visit)
X
X
X
X
X
X
X
X
X
Rescue Medication 
Monitoring
X
X
X
X
X
X
X
X
AE/SAE recording
----------------------------------------------------------------------------------------------------------------------------------------
Concomitant 
Medications/Therapies
X
X
X
X
X
X
X
X
X
a.
Screening visit may occur up to 21 days prior to Day 1, to allow for medication washout.
b.
Any patients withdrawing prematurely must complete all Week 26 assessments at their last study visit.
c.
Written informed consent will be obtained prior to any study-specific procedures, including washout of any 
prohibited medications.
d.
Including inguinal region of the target knee (adenopathy).
e.
Total bilirubin (and, in case of values above the normal range, differentiation in conjugated and nonconjugated 
bilirubin), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), 
gamma-glutamyl transpeptidase (GGT). Biochemistry tests include fasting glycemia, serum electrolytes and 
serum creatinine.
f.
Females of childbearing potential only. A woman is considered of reproductive potential (WOCBP), i.e., fertile, 
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following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization 
methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
g.
An X-ray is only required at screening visit if the patient has not had a valid X-ray within3 months prior to 
screening visit
h.
The evaluator’s COGA assessment must be performed following the patient’s completion of questionnaires.
i.
Assessment of prohibited medication must occur prior to administration of study drug. WOMAC: Western Ontario 
and McMaster Universities Osteoarthritis Index; NRS: Numerical Rating Scale; PTGA: Patient global assessment; 
COGA: Clinical observer global assessment; EQ-5D: EuroQol five dimensions; IMP: investigational medicinal 
product; AE: adverse event; SAE: serious adverse event
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Appendix B
Summary of statistical analyses
EFFICACY ANALYSIS
Endpoint
Analysis
population
Primary
analysis
Supportive
analysis
Subgroup
analysis
Other
analyses
Primary endpoint
the mean change from 
baseline in WOMAC A1 
between Hylan G-F 20 and 
placebo over 26 weeks
mITT
repeated-measures Analysis of 
Covariance (ANCOVA)
multiple imputation 
(MI) methods based 
on pattern mixture 
models
Yes Subgroups: 
age, BMI category, 
baseline WOMAC 
A1 score, etc.
No
Secondary endpoints
the change from baseline in 
7-day average WOMAC A1, 
WOMAC A, PTGA, and 
COGA
mITT
repeated-measures Analysis of 
Covariance (ANCOVA)
No
Yes
No
WOMAC A1 responders
generalized estimating equations 
(GEE) modeling
No
No
No
tertiary endpoints
the change from baseline in 
WOMAC A1, 7-day average 
WOMAC A1, WOMAC A, B, 
C and total, PTGA, COGA 
and quality of life
mITT
repeated-measures Analysis of 
Covariance (ANCOVA)
No
No
No
the change from baseline in 
the amount and days of 
permitted pain rescue 
medication
Wilcoxon Mann Whitney test
No
No
No
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Endpoint
Analysis
population
Primary
analysis
Supportive
analysis
Subgroup
analysis
Other
analyses
m ITT =modified intent-to-treat;
SAFETY ANALYSES
Endpoint
Analysis
population
Primary analysis
Supportive
analysis
Subgroup
analysis
Other
analyses
Adverse events
Safety
Follow safety guidelines
No
No
No
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Appendix C
Potentially clinically significant abnormalities criteria
For phase 2/3 studies (oncology excepted)
(from BTD-009536-version 3.0-21-MAY-2014)
Vital signs
HR
≤50 bpm and decrease from baseline ≥20 bpm
≥120 bpm and increase from baseline≥20 bpm
To be applied for all positions (including missing) except STANDING.
SBP
≤95 mmHg and decrease from baseline ≥20mmHg
≥160 mmHg and increase from baseline ≥20 mmHg
To be applied for all positions (including missing) except STANDING.
DBP
≤45 mmHg and decrease from baseline ≥10 mmHg
≥110 mmHg and increase from baseline ≥10 mmHg
To be applied for all positions (including missing) except STANDING.
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ELECTRONIC SIGNATURES 
 
Signed by 
Meaning of Signature 
Server Date 
(dd-MMM-yyyy HH:mm) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
EFC12723 16.1.9 Statistical analysis plan
Clinical Approval
30-Jan-2019 22:27 GMT+0100
Clinical Approval
31-Jan-2019 04:18 GMT+0100