A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Phase: PHASE2
Conditions: Plantar Fasciitis
Sponsor: Revance Therapeutics, Inc.

DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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Revance Therapeutics, Inc.  
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CLINICAL STUDY PROTOCOL 
A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-
Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of 
Plantar Fasciitis  
 
Protocol Number: 
1820201 
 
IND Number: 
IND 128510 
 
National Clinical Trial 
Identified Number: 
NCT03825315 
 
Sponsor: 
Revance Therapeutics, Inc 
 
7555 Gateway Boulevard 
 
Newark, California 94560, USA 
 
Telephone: (510) 742-3400 
 
Protocol Version:  
4.0 
 
Protocol Date: 
15 July 2019 
 
 
 
 
CONFIDENTIALITY STATEMENT: The information contained in this document is the property of 
Revance Therapeutics, Inc. and is confidential. This information may not be disclosed, reproduced, or 
distributed to anyone other than personnel directly involved in the conduct of the study and in response to 
a relevant Institutional Review Board/Independent Ethics Committee and Review by a Regulatory 
Authority as required by the applicable laws and regulations, without the written authorization of Revance 
Therapeutics, Inc. These restrictions will continue to apply after the study has closed. 

DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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INVESTIGATOR’S AGREEMENT 
I have carefully read the protocol entitled: “A Phase II, Prospective, Randomized, Double-Blind, Multi-
center, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar 
Fasciitis” and, I will provide copies of the protocol, any subsequent protocol amendments, and access to 
all information provided by the sponsor/CRO to the site staff under my supervision. I will discuss this 
material with them to ensure that they are fully informed about the investigational drug and the study 
protocol. 
I agree to conduct this clinical study according to the attached protocol, in compliance with all applicable 
laws and regulations, and in accordance with the ethical principles stipulated in the Declaration of 
Helsinki.  
 
 
 
_____________________________________________________ 
Investigator Signature 
 
____________________________
Date 
 
_____________________________________________________ 
Printed Name 
 
 
_____________________________________________________ 
Institution Name 
 
 
_____________________________________________________ 
Address 
 
 
_____________________________________________________ 
City, State, Postal Code, Country 
 
____________________________
Phone Number 
 
 
 
 
 
 
 
 

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2 
TABLE OF CONTENTS 
 
 
2 
Table of Contents ............................................................................................................................ 11 
 
 
 
 
3 
List of Abbreviations ....................................................................................................................... 14 
4 
Statement of Compliance ................................................................................................................ 17 
5 
Protocol Summary ........................................................................................................................... 18 
5.1 
Synopsis ................................................................................................................................. 18 
 
 
 
 
6 
Introduction ..................................................................................................................................... 25 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7 
Objectives and Endpoints ................................................................................................................ 36 
8 
Study Design ................................................................................................................................... 38 
8.1 
Overall Design ....................................................................................................................... 38 
 
 
 
 
 
 
8.5 
Duration of Trial .................................................................................................................... 39 
 
 
8.7 
End of Study Definition ......................................................................................................... 40 
9 
Study Population ............................................................................................................................. 40 
9.1 
Inclusion Criteria ................................................................................................................... 40 
9.2 
Exclusion Criteria .................................................................................................................. 41 
9.3 
Lifestyle Considerations ........................................................................................................ 44 
 
 
9.4 
Screen Failures ....................................................................................................................... 45 
9.5 
Re-Screenings ........................................................................................................................ 45 
9.6 
Strategies for Recruitment and Retention .............................................................................. 45 
 
 
 
 
 
 
 

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10.6 
Concomitant Therapy ............................................................................................................ 50 
10.6.1 
Rescue Medicine .................................................................................................. 50 
11 
Study Intervention Discontinuation and Subject Discontinuation/Withdrawal ............................... 50 
11.1 
Discontinuation of Study Intervention ................................................................................... 50 
11.2 
Early Discontinuation/Withdrawal Procedures ...................................................................... 51 
11.3 
Lost to Follow-Up .................................................................................................................. 51 
12 
Study Assessments and Procedures ................................................................................................. 52 
12.1 
Study Assessments ................................................................................................................. 52 
12.1.1 
Screening Visit ..................................................................................................... 52 
12.1.2 
Run-in Period ....................................................................................................... 53 
12.1.3 
Day 1 Treatment Visit .......................................................................................... 53 
12.1.4 
Follow-up Visits .................................................................................................. 54 
12.2 
Efficacy Assessments ............................................................................................................ 55 
12.3 
Safety Assessments ................................................................................................................ 56 
12.3.1 
Adverse Events .................................................................................................... 56 
12.3.2 
Clinical Laboratory Tests ..................................................................................... 62 
12.3.3 
12-Lead Electrocardiograms (ECGs) ................................................................... 63 
12.3.4 
Injection Site Evaluation ...................................................................................... 63 
12.3.5 
Hypersensitivity Evaluation ................................................................................. 63 
12.3.6 
Physical Examinations ......................................................................................... 64 
12.3.7 
Foot and Ankle Examination ............................................................................... 64 
12.3.8 
Height, Weight, Vital Signs ................................................................................. 64 
12.3.9 
Columbia-Suicide Severity Rating Scale ............................................................. 64 
12.3.10 
Reporting of Pregnancy ....................................................................................... 64 
12.3.11 
Pregnancy Testing................................................................................................ 65 
12.3.12 
Imaging  ............................................................................................................... 65 
12.4 
Unanticipated Adverse Events ............................................................................................... 65 
12.4.1 
Definition of Unanticipated Adverse Events ....................................................... 65 
12.4.2 
Unanticipated Adverse Event Reporting ............................................................. 66 
12.4.3 
Reporting Unanticipated Adverse Events to Subjects ......................................... 67 
13 
Statistical Considerations ................................................................................................................ 67 
13.1 
Sample Size Determination ................................................................................................... 67 
13.2 
Populations for Analyses ....................................................................................................... 67 
13.3 
Statistical Analyses ................................................................................................................ 68 
13.3.1 
General Considerations ........................................................................................ 68 
13.3.2 
Analysis of the Primary Efficacy Endpoint ......................................................... 68 

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14 
Supporting Documentation and Operational Considerations .......................................................... 71 
14.1 
Regulatory, Ethical, and Study Oversight Considerations ..................................................... 71 
14.1.1 
Informed Consent Process ................................................................................... 71 
 
 
 
 
 
 
14.1.5 
Safety Monitoring/Data MAnagement ................................................................ 73 
14.1.6 
Monitoring, Compliance, and Quality ................................................................. 73 
14.1.7 
Data Quality Assurance Audits and Quality Control ........................................... 74 
14.1.8 
Protocol Deviations .............................................................................................. 77 
 
 
 
 
14.2 
Additional Considerations ..................................................................................................... 78 
14.2.1 
Ethics and Responsibility ..................................................................................... 78 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3 
LIST OF ABBREVIATIONS 
 
Abbreviation 
Definition 
AE 
Adverse event 
ANCOVA 
Analysis of covariance 
BMI 
Body Mass Index 
BoNT 
Botulinum toxin 
BoNTA 
Botulinum toxin type A 
CD 
Cervical dystonia 
CI 
Confidence interval 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
CGIC 
Clinical Global Impression of Change 
CS 
Clinically significant 
C-SSRS 
Columbia – Suicide Severity Rating Scale 
DAXI  
DaxibotulinumtoxinA, previously referred to as RTT150 
DAXI for injection 
DaxibotulinumtoxinA for injection, previously referred to as RT002 
DMC 
Data Monitoring Committee  
ECG 
Electrocardiogram 
EOS 
End of study 
ePRO 
Electronic Patient Reported Outcome 
ET 
Early termination 
FAAM 
Foot and Ankle Ability Measure 
FDA 
Food and Drug Administration (United States) 
FFI 
Foot Function Index 
GCP 
Good Clinical Practices 
GLMM 
Generalized Linear Mixed Model 
ICH 
International Council On Harmonisation 
IEC 
Independent Ethics Committee 
IM 
Intramuscular(ly) 
IND 
Investigational New Drug 
IP 
Investigational product 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 

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Abbreviation 
Definition 
ISF 
Investigator Site File 
ITT 
Intent-to-treat 
kg 
Kilograms 
kDa 
Kilodalton 
NPRS 
Numeric Pain Rating Scale 
Onabot 
OnabotulinumtoxinA 
PF 
Plantar fasciitis 
PGIC 
Patient Global Impression of Change 
PI 
Principal investigator 
PP 
Per protocol 
PPT 
Pressure Pain Threshold 
PT 
Prothrombin time  
QT 
Measure of time between start of the q wave and the end of the t wave 
in the heart’s electrical conduction 
QTcF 
Corrected QT interval using Fridericia's correction formula 
Revance 
Revance Therapeutics, Inc. 
RICE 
rest, ice, compression, and elevation 
RT002 
Previous company name for drug product daxibotulinumtoxinA for 
injection 
RTP004 
Revance novel excipient 
RTT150 
Previous company name for drug substance, daxibotulinumtoxinA 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SIV 
Site Initiation Visit 
SOA 
Schedule of Assessments 
SOP 
Standard operating procedure 
SPT 
Serum pregnancy test 
TdP 
Torsades de Pointes 
TEAE 
Treatment-emergent adverse event 
TMF 
Trial Master File 
TSQ 
Treatment Satisfaction Questionnaire 
TWSTRS 
Toronto Western Spasmodic Torticollis Rating Scale 
U 
Units (botulinum toxin) 
UP 
Unanticipated problem 

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Abbreviation 
Definition 
UPT 
Urine pregnancy test 
US 
United States 
VAS 
Visual Analogue Scale 
WOCBP 
Women of child bearing potential 
 

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STATEMENT OF COMPLIANCE 
The study will be conducted in accordance with the International Council On Harmonisation Good 
Clinical Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations (CFR) 
Terms and Conditions of Award. The Principal Investigator (PI) will assure that no deviation from, or 
changes to the protocol will take place without prior agreement from the Investigational New Drug (IND) 
sponsor, funding agency and documented approval from the Institutional Review Board (IRB), except 
where necessary to eliminate an immediate hazard(s) to subjects. All personnel involved in the conduct of 
this study have completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all subject materials will be submitted 
to the IRB for review and approval. Approval of both the protocol and the consent form must be obtained 
prior to subject enrollment. Any amendment to the protocol will require review and approval by the IRB 
before the changes are implemented to the study. All changes to the consent form will be IRB approved; a 
determination will be made regarding whether a new consent needs to be obtained from subjects who 
provided consent, using a previously approved consent form. 
 

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PROTOCOL SUMMARY 
5.1 
SYNOPSIS  
Title: 
A Phase II, Prospective, Randomized, Double-Blind, Multi-center, Placebo-
Controlled Trial of DaxibotulinumtoxinA for Injection for the Management 
of Plantar Fasciitis 
Study Description: 
This is a randomized, double-blind, placebo-controlled, multi-center study 
of two doses of daxibotulinumtoxinA (DAXI) for injection in adult subjects 
with unilateral plantar fasciitis (PF). 
Approximately 150 subjects recruited from approximately 20 investigator 
sites in the US will be randomized 
 
 
 
 
PIs, site staff (excluding unblinded dose preparers), subjects, and 
 
 
 
 
 
 
 
  
The primary efficacy endpoint is the change from baseline in the Numeric 
Pain Rating Scale (NPRS) score at Week 8.  
In case of no improvement, defined as no change or worsening of the NPRS 
score from baseline, Week 8 will serve as the early completion visit for the 
subject (i.e., the “early study completer”). Subjects who experience any 
treatment benefit (any decrease from baseline on NPRS score) will continue 
in the study. NPRS scores will be collected by subjects daily in an ePRO 
diary. Algometry, Clinical Global Impression of Change (CGIC), and 
Patient-reported Outcomes (PROs; i.e., Foot Function Index [FFI], Foot and 
Ankle Ability Measure [FAAM], Patient Global Impression of Change 
[PGIC] and Treatment Satisfaction Questionnaire [TSQ]) will be performed 
at prespecified time points during the study, as efficacy evaluations.  Safety 
will be assessed based on adverse events (AEs), clinical laboratory 
parameters, vital signs, 12-lead electrocardiograms (ECGs),
 
 physical examination, and the Columbia – Suicide Severity Rating 
Scale (C-SSRS).

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Trial Objective: 
 
To compare the efficacy and safety of two doses of DAXI for 
injection versus placebo for managing plantar fasciitis 
Endpoints: 
Primary Efficacy Endpoint:  
 
Change from baseline in the NPRS score, which is recorded within 
15 minutes after stepping out of bed in the morning and averaged 
over 5 days (defined as 4 days prior to study visit and on the study 
visit day), at Week 8 
  
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
  
 
 
 
   

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Safety Endpoints 
 
Frequency, severity and relationship to study drug of treatment-
emergent adverse events during the first 8 weeks post treatment 
and the overall study duration  
 
Frequency, severity and relationship to study drug of treatment-
emergent serious adverse events during the first 8 weeks post 
treatment and the overall study duration  
Study Population: 
Subjects aged 18-65, inclusive, with unilateral PF for ≥ 3 months and 
≤ 15 months, have failed conservative treatment, and have an NPRS score 
of ≥ 5 and ≤ 9, and have not previously received botulinum toxin therapy in 
the lower extremities or feet.
Phase: 
2  
Description of 
Sites/Facilities 
Enrolling Subjects: 
Approximately 20 sites in the US will participate in the study. 
Approximately 150 subjects will be randomized. 
Description of Study 
 
 
 
 
 
 
 
 
 
 
Study Duration: 
Approximately 21 months
Subject Duration: 
The study duration for each subject is approximately 7 months (up to 14 
days for screening, 7 days [+3] for run-in, Treatment Day 1, and up to 24 
weeks for follow-up).
Sample Size 
Justification: 
The sample size calculations are based on the minimal clinically important 
difference of 2 points for NPRS (Farrar, 2001; Michener, 2011).  
 
 
 
 
 
 
 
 
 

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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
 
 
 
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8 
6 
 
INTRODUCTION 

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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
 
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7 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
Trial 
To compare the efficacy and 
safety of two doses of DAXI 
for injection versus placebo 
for managing plantar fasciitis 
Primary Efficacy Endpoint: 
 
Change from baseline/treatment in NPRS 
score as recorded within 15 minutes of 
taking first step when getting out of bed in 
the morning (average over 5 days, defined 
as 4 days prior to study visit and on the 
study visit day) at Week 8.   
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
Clinically relevant 
outcome measure for 
this indication. 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION 
FOR ENDPOINTS 
 
 
 
 
 
 
  
 
Safety Endpoints: 
 
Frequency, severity and relationship to 
study drug of treatment-emergent 
adverse events during the first 8 weeks 
post treatment and the overall study 
duration  
 
Frequency, severity and relationship to 
study drug of treatment-emergent 
serious adverse events during the first 8 
weeks post treatment and the overall 
study duration  

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8 
STUDY DESIGN 
8.1 
OVERALL DESIGN 
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of two doses of DAXI 
for injection in adult subjects with unilateral PF. 
Approximately 150 subjects, recruited from approximately 20 investigator sites in the US will be 
randomized
 
 
Imaging (e.g., x-ray or sonography) of the foot will be used to rule out concomitant disease conditions.  
 
 
  
 
 
 
 
The primary efficacy endpoint is the change from baseline in NPRS score (average over 5 days, defined 
as 4 days prior to study visit and on study visit day) at Week 8.  Daily NPRS scores will be recorded in an 
ePRO diary within the first 15 minutes after the first steps out of bed in the morning. 
In cases of no improvement, Week 8 will serve as the early completion visit for the subject (i.e., the 
“early study completer”). Subjects who experience any treatment benefit, defined as any decrease in 
NPRS score from baseline, will continue to be observed up until Week 24 (see Section 8.7 for additional 
detail). The NPRS score will be recorded daily in an ePRO diary by the subject, as the primary efficacy 
evaluation. At site visits, algometry (to determine PPT), FFI, FAAM, CGIC, PGIC, and TSQ will be 
performed at prespecified time points during the study.   
Safety assessments are AE monitoring
, clinical 
laboratory tests (hematology, prothrombin time, chemistry, and urinalysis), pregnancy tests for WOCBP, 
, physical examinations, vital signs, 12 lead ECGs, C-SSRS, injection site 
evaluations, and concomitant medications. 
 
 
 
 
 
  

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8.5 
DURATION OF TRIAL 
The study duration for each subject is approximately 7 months (up to 14 days for screening, 7 days [+3] 
for run-in, and up to 24 weeks for follow-up after the Day 1 treatment visit). 
 
 
 
 
 
 
 

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8.7 
END OF STUDY DEFINITION 
Study completion may occur at Week 8 (“early study completers” who have no treatment benefit based on 
NPRS) or at Week 24 (“study completers”): 
Week 8 Early Study Completers: 
 
No Treatment Benefit:  
o Subjects who do not demonstrate improvement at Week 8, where improvement is defined as 
any decrease from baseline on NPRS score  
o A subject may also complete the study at Week 8 based on the investigator’s clinical 
judgment of no clinical improvement following treatment, regardless of whether the subject 
showed a treatment benefit based on the NPRS score evaluation described above.   
Week 24 Study Completers: 
 
Treatment Benefit: Subjects who demonstrate improvement at Week 8, defined as any decrease 
from baseline on NPRS score, should continue in the study for follow-up until Week 24 and will 
be considered “complete” following the conclusion of their Week 24 visit. 
For subjects who choose to discontinue from the study prior to these timepoints for any reason, every 
effort should be made to complete the Week 24/ET visit.  
9 
STUDY POPULATION  
9.1 
INCLUSION CRITERIA 
All subjects must meet the following inclusion criteria at screen or if indicated at screening and baseline:  
1. Able to understand the nature of the study and protocol requirements and provide written 
informed consent and including authorization to release health information. 
2. Male or female subjects 18 to 65 years of age inclusive with diagnosis of unilateral PF.  
3. Upon physical exam, unilateral presence of pain upon palpation over medial calcaneal tuberosity. 
4. Persistent heel pain at the insertion of the plantar fascia in the posterior-inferior medial calcaneal 
tuberosity for 3 months or more, but not to exceed 15 months 
 
  
 
 
 

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9.2 
EXCLUSION CRITERIA 
Subjects will not be enrolled if they meet any of the following exclusion criteria at screening: 
1. Non-ambulatory  
2. BMI > 32.5 kg/m2 
3. Pain anywhere else in the foot, elicited upon palpation or ongoing, other than at the insertion 
of the plantar fascia on calcaneus. 
4. Previous injection of botulinum toxin in the lower extremities or feet. 
5. More than one steroid injection for the treatment of current PF in the affected foot or 
administered within 3 months prior to screening.   
6. Study foot has been previously treated with tissue engineered materials. 
7. History of radiation on plantar surface of foot. 
8. History of a partial or full thickness tear or surgery of the plantar fascia. 

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9.3 
LIFESTYLE CONSIDERATIONS 

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9.4 
SCREEN FAILURES 
Screen failures are subjects from whom written informed consent has been obtained, but who do not meet 
all eligibility requirements per protocol. Screen failed subjects will be excluded from study participation, 
however, they may be considered for one-time re-screening in consultation with the sponsor/CRO. 
9.5 
RE-SCREENINGS 
Screen failed (those that do not meet all eligibility requirements per protocol) may be considered for one-
time re-screening in consultation with the sponsor/CRO. For re-screening, subjects will be assigned a new 
subject number in the study and must fulfill all eligibility requirements per protocol. 
Subjects that underwent imaging of their foot during their initial screening visit will not be required to 
repeat this assessment.  
Subjects that screen fail for a second time will not be permitted to re-screen further. 
9.6 
STRATEGIES FOR RECRUITMENT AND RETENTION 
The recruitment and retention plan for this study will be provided separately. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10.6 CONCOMITANT THERAPY 
Concomitant medications are any prescription or over-the-counter preparations used by subjects during 
participation in the study.  Use of concomitant medications will be recorded on the Concomitant 
Medications CRF beginning at Screening through Week 24/ET.  The dose and dosing regimen of all 
prescription and non-prescription therapies and medications, including herbs, vitamins, or other 
nutritional supplements administered will be documented. 
Use of prohibited medications/treatments as described in Section 9.3.1 will be considered as a protocol 
deviation.   
10.6.1 RESCUE MEDICINE 
At the Week 8 visit, the following 2 categories of subjects will be identified to the sites: 
 
subjects having no improvement from baseline on NPRS scores (see Section 8.7)  
 
subjects having improvement from baseline of <20% based on NPRS scores  
Prior to Week 8, the protocol does not allow for any type of rescue medication for the treatment of PF.  At 
Week 8, for subjects with <20% reduction from baseline in their NPRS score at Week 8, physician-
prescribed physical therapy will be permitted upon subject request.   
Subjects may withdraw from the study at any time if medication is required to address the subject’s 
symptoms associated with PF (in addition to other reasons a subject may have for early discontinuation). 
11 STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL 
11.1 DISCONTINUATION OF STUDY INTERVENTION 
Study subjects will receive a one-time only treatment for this study.  Discontinuation of study treatment is 
not applicable.  However, subjects may choose to discontinue their participation in the follow-up phase at 
any time.  Refer to Early Discontinuation/Withdrawal Procedures, Section 11.2, for more details.  

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11.2 EARLY DISCONTINUATION/WITHDRAWAL PROCEDURES 
A subject may voluntarily withdraw from study participation at any time.  If the subject withdraws 
consent and discontinues from the trial, the PI will attempt to determine the reason for discontinuation 
and record the reason in the subject’s study records and on the CRF.  If a subject withdraws consent 
because of an AE, that AE should be indicated as the reason for withdrawal.  In the event of early 
discontinuation, (i.e., prior to Week 24) and whenever possible, the subject should be asked to return to 
the investigator site to complete the assessments specified for Week 24/ET.  Subjects who withdraw from 
the study will not be replaced. Early study completers, as defined in Section 8.7 will also complete the 
Week 24/ET CRF, at the time of study exit (ie, Week 8 visit). 
If at any time during the trial, the PI determines that it is not in the best interest of the subject to continue, 
the subject will be discontinued from participation.  The PI can discontinue a subject from study 
participation at any time if medically necessary or if the subject has failed to follow study procedures or 
to keep follow-up appointments.  Appropriate documentation in the subject’s study record and CRF 
regarding the reason for discontinuation must be completed. Prior to discontinuing a subject from study 
participation, the PI will discuss his/her intentions with the medical monitor or designee. 
All subjects who fail to return to the investigator site for the required follow-up visits will be contacted by 
phone to determine the reason(s) why the subject failed to return for the necessary visit or elected to 
discontinue from the study.  If a subject is unreachable by telephone after a minimum of 2 documented 
attempts (1 attempt on 2 different days), a registered letter will be sent requesting that contact be made 
with the PI.  
The sponsor/CRO has the right to terminate or to stop the study at any time. Should this be necessary, 
both the sponsor/CRO and the PI will ensure that proper study discontinuation procedures are completed.   
11.3 LOST TO FOLLOW-UP 
A subject will be considered lost to follow-up if he or she fails to return for scheduled study visits and is 
unable to be contacted by investigator site staff.  
The following actions must be taken if a subject fails to return to the clinic for a required study visit: 
 
The investigator site will attempt to contact the subject and reschedule the missed visit(s) and 
counsel the subject on the importance of maintaining the assigned visit schedule and ascertain if 
the subject wishes to and/or should continue in the study. 
 
Before a subject is deemed lost to follow-up, the PI or designee will make every effort to regain 
contact with the subject (where possible, 2 telephone calls and, if necessary, a certified letter to 
the subject’s last known mailing address or local equivalent methods).  These contact attempts 
should be documented in the blinded ISF.  
 
Should the subject continue to be unreachable, he or she will be considered to have withdrawn 
from the study with a primary reason of lost to follow-up. 

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12 STUDY ASSESSMENTS AND PROCEDURES 
12.1 STUDY ASSESSMENTS 
All clinical laboratory assessments will be conducted by a central lab. 
12.1.1 SCREENING VISIT 
Subjects presenting with heel pain will be examined to verify a diagnosis of PF. Once verified, subjects 
with PF will be screened to determine if they meet the study eligibility criteria and informed of all 
requirements for study participation.  Subject informed consent and applicable privacy authorization must 
be obtained prior to conducting screening procedures. Refer to Section 5.3 Schedule of Assessments, for 
activities to be performed. 
After the informed consent is obtained, the following procedures will be completed: 
 
Demographics, complete medical/surgical history, and physical examination 
 
Foot and ankle examination of both feet (including range or motion and motor strength) 
 
Collect vital signs (blood pressure [BP], pulse, temperature, respiration rate), weight, and height 
 
Collect blood samples for clinical laboratory (chemistry, hematology, urinalysis), 
 
 
 
 
C-SSRS (Baseline Version) 
 
Collect ECG  
 
Collect foot imaging (X-rays or sonography) if not done within the last 6 months; if performed 
within the last 6 months, the image must be available for evaluation by the investigator at the time 
of screening to determine eligibility  
 
Collect concomitant medications/therapies 
 
Dispense ePRO diary and train the subject on its use for capturing NPRS scores every morning 
within 15 minutes after getting out of bed for the day. The subject must bring this diary to the 
clinic at each subsequent follow up visit.  
 
FFI 
Results from clinical laboratory tests and cardiologist-interpreted ECG must be obtained, reviewed, and 
signed by the PI.  Any abnormal results must be determined to be not clinically significant by the PI prior 
to randomization.  Any WOCBP having a positive pregnancy test pre-treatment will not be enrolled in the 
study. 

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12.1.2 RUN-IN PERIOD 
The NPRS will be completed through an ePRO diary entry by the subject, measured within 15 minutes of 
stepping out the bed in the morning for the course of the run-in period. Subjects will not be required to 
return to the investigator site at this time. 
12.1.3 DAY 1 TREATMENT VISIT 
The following procedures will be completed pre-treatment:  
 
Confirm subject eligibility.  
 
Medical history and physical examination 
 
 
 
Collect vital signs (BP, pulse, temperature, respiration rate) and weight 
 
C-SSRS (since last visit) 
 
 
 
 
 
 
 
 
 
  
 
  
 
 
 
 
 
 
 
After study eligibility is confirmed, as defined by the eligibility criteria in Sections 9.1 and 9.2, the 
 
 
 
 
 
 
 
 
 
  

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12.1.4 FOLLOW-UP VISITS 
Subjects will be evaluated 8 times following Day 1 Treatment Visit completion at Weeks 1, 2, 4, 8, 12, 
16, 20 and 24/ET.  The following procedures will be completed at each follow-up visit unless otherwise 
specified:  
 
 
 
 
 
 
 
Collect vital signs (BP, pulse, temperature, respiration rate) and weight 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
Collect concomitant medications/therapies and AE(s) 

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Variation from Scheduled Visit Days 
To allow for scheduling flexibility, limited variation will be permitted from the specified time of each 
visit as in table shown below.  
Allowed Variation from Scheduled Visit Days 
Scheduled Visit 
Allowed Variation 
Weeks 1 and 2 
± 2 days 
Weeks 4, 8, 12, 16, 20 and 24 
± 3 days 
12.2 EFFICACY ASSESSMENTS  
The timing of all efficacy assessments is as described in the Schedule of Assessments in Section 5.3. 
Numeric Pain Rating Scale (NPRS): (Ferreira-Valente, 2011; McCaffery, 1989; Jensen, 2015; 
Dworkin, 2005)  The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a 
respondent selects a whole number (0–10 integers) that best reflects the intensity of his/her pain.  The 
common format is a horizontal bar or line.  Similar to the VAS, the NPRS is anchored by terms 
describing pain severity extremes.  See APPENDIX B 
FFI (Foot Function Index): The FFI (Budiman-Mak, 1991) was developed to measure the impact of foot 
pathology on function in terms of pain, disability and activity restriction and is a self-administered index 
consisting of 23 items divided into 3 sub-scales.  Both total and sub-scale scores are produced.  The FFI 
can be applied to the effect of PF on foot function.  Foot function and pain levels directly can be 
correlated with treatment outcomes in the Revance Phase 2 study.  See APPENDIX C 
FAAM (Foot and Ankle Ability Measure): The FAAM was developed to comprehensively assess 
physical performance among individuals with leg, and ankle musculoskeletal disorders (Martin, 2005).  
The FAAM can be applied to performance as relates to PF.  See APPENDIX D 
CGIC (Clinical Global Impression of Change): The CGIC is a questionnaire that captures the 
clinician’s overall impression of the subject’s response to study treatment.  The clinician’s selected 
response maps to a 7-point scale: -3 (very much worse), 0 (about the same), to +3 (very much better). 
(Guy, 1976). See APPENDIX E.   
PGIC (Patient Global Impression of Change):  The PGIC is a questionnaire that captures the subject’s 
overall impression of their response to study treatment.  The subject’s selected response maps to a 7-point 
scale: -3 (very much worse), 0 (about the same), to +3 (very much better). (Farrar, 2001).  See 
APPENDIX F. 
TSQ (Treatment Satisfaction Questionnaire):  The TSQ is self-administered instrument that measures 
the subject’s overall satisfaction with his or her study treatment (Revicki, 2004).  See APPENDIX G. 
Algometry: Pressure algometers are designed to measure deep pressure pain thresholds or tenderness 
resistance.  When a particular site of the body is pressed with a rubber disk having an area of 1 cm2, the 
device displays the pressure (Park, 2011).  PPT will be measured by algometry beginning pre-treatment 
on Day 1 and at each subsequent clinic visit at Weeks 1, 2, 4, 8, 12, 16, 20, and 24/ET.  The PI will 
identify the point of maximum tenderness and mark the spot, position the digital pressure algometer and 

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press against until the subjects reports pain (note; this is the minimal amount of pain, not pressure).  The 
pressure pain threshold is measured 3 times, with at least 1 minute between each evaluation, and the peak 
reading when pain is first reported recorded in kg/cm2 for each test.   
12.3 SAFETY ASSESSMENTS 
The timing of all safety assessments is as described in the Schedule of Assessments in Section 5.3. 
12.3.1 ADVERSE EVENTS  
12.3.1.1 ASSESSMENT OF ADVERSE EVENTS 
AEs will be graded as mild, moderate, or severe as defined in Section 12.3.1.2.3 of this protocol. 
Section 12.3.1.2.5 outlines the procedures for recording and reporting AEs. 
AEs will be reported by the sponsor in accordance with “21CRF part 312.32 and Guidance for Industry 
and Investigators: Safety Reporting Requirements.”  The PI will report any SAEs to the IRB. 
 
 
 
 
 
 
 
 
 
 
 
 
12.3.1.2 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
12.3.1.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
For this protocol, an AE is any untoward medical occurrence (e.g., sign, symptom, disease, syndrome, 
intercurrent illness, clinically significant abnormal laboratory finding, injury or accident) that emerges or 
worsens following administration of IP and until the end of study participation that may not necessarily 
have a causal relationship to the administration of the IP.  An AE can therefore be any unfavorable and/or 
unintended sign (including a clinically significant abnormal laboratory result), symptom, or disease 
temporally associated with the use of an IP, whether or not considered related to the IP.  A treatment-
emergent AE is one that occurs after any period of exposure to treatment. 
Pre-existing conditions, which increase in frequency or severity or a change in nature as a consequence of 
an IP use will also be considered an AE. 

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An unexpected AE is an adverse reaction, the nature or severity of which is not consistent with the 
applicable product information (e.g., Investigator’s Brochure for an unapproved IP or package 
insert/summary of product characteristics for an approved product). 
Any clinically significant change in the study safety evaluations, (e.g., vital signs, laboratory results, 
ECG, injection site evaluation, physical/neurological examinations, etc.) post-treatment must be reported 
as an AE. 
12.3.1.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An SAE is any untoward medical occurrence that results in any of the following outcomes: 
 
Death 
 
Life-threatening, (i.e., the subject was, in the opinion of the PI and/or sponsor/CRO, at immediate 
risk of death from the event as it occurred. It does not apply to an AE that hypothetically might 
have caused death if it were more severe) 
 
Persistent or significant disability/incapacity or substantial disruption of the subject’s ability to 
carry out normal life functions 
 
Requires in-patient hospitalization or prolongs hospitalization (i.e., a prolonged hospitalization 
beyond the expected length of stay; hospitalizations for elective medical/surgical procedures, 
scheduled treatments, or routine check-ups are not SAEs by this criterion) 
 
Congenital anomaly/birth defect (i.e., an adverse outcome in a child or fetus of a subject exposed 
to the molecule or IP before conception or during pregnancy) 
 
Does not meet any of the above serious criteria but based upon appropriate medical judgement 
may jeopardize the subject or may require medical or surgical intervention to prevent one of the 
outcomes listed above (i.e., is a significant or important medical event) 
12.3.1.2.3 CLASSIFICATION OF AN ADVERSE EVENT 
Severity of Event 
The PI is responsible for evaluating all AEs and determining the severity of the event.  Severity will be 
categorized as mild, moderate or severe according to the following definitions: 
 
Mild: Event may be noticeable to subject; does not influence daily activities; usually does not 
require intervention 
 
Moderate: Event may be of sufficient severity to make subject uncomfortable; performance of 
daily activities may be influenced; intervention may be needed 
 
Severe: Event may cause severe discomfort; usually interferes with daily activities; subject may 
not be able to continue in the trial; treatment or other intervention usually needed 

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Relationship to Study Intervention 
Relationship of an AE to IP will be assessed by the PI as follows: 
 
Definite: There is a clinically plausible time sequence between the onset of the AE and the 
administration of IP; when the event responds to withdrawal of IP and/or recurs with re-
administration of IP 
 
Probable: There is a clinically plausible time sequence between the onset of the AE and the 
administration of IP; the AE is unlikely to be caused by the concurrent/underlying illness, 
other drugs or procedures 
 
Possible: There may or may not be a clinically plausible time sequence between the onset of 
the AE and the administration of IP and a cause cannot be ruled out 
 
Unrelated: There is not a temporal or causal relationship to IP administration 
Expectedness  
The medical monitor and sponsor/CRO will be responsible for determining whether an AE is expected or 
unexpected.  An AE will be considered unexpected if the nature, severity, or frequency of the event is not 
consistent with the risk information previously described for the study intervention.  Expectedness is 
further defined in the Investigator’s Brochure (IB) under Anticipated Risks and Side Effects. The list of 
AEs found in the IB can be considered to be expected AEs.   
12.3.1.2.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND 
FOLLOW-UP 
The occurrence of an AE or SAE may come to the attention of investigator site staff during study visits 
and interviews of a subject presenting for medical care, or upon review by the blinded monitor. 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate CRF.  Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study product (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event.  All AEs occurring while 
on study must be documented appropriately regardless of relationship.  All AEs will be followed to 
adequate resolution. 
Any medical condition that is present at the time that the subject is screened will be considered as medical 
history and not reported as an AE.  However, if the subject’s condition deteriorates at any time following 
injection at their Day 1 Treatment visit will be recorded as an AE.  
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed.  AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
The PI or investigator site staff will record all reportable events with start dates occurring any time after 
informed consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of 
study participation.  At each study visit, the PI or investigator site staff will inquire about the occurrence 

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of AE/SAEs since the last visit.  Events will be followed for outcome information until resolution or 
stabilization. 
12.3.1.2.5 ADVERSE EVENT REPORTING  
The PI will assess subject post-treatment and at each subsequent study visit for the occurrence of AEs.  In 
order to avoid bias in eliciting AEs, subjects should be asked the following non-leading question: “How 
have you felt since your last visit?” All AEs (serious and non-serious) reported by the subject must be 
recorded on the source documents and CRFs.  
In addition, PIs and/or investigator site staff must report an SAE to the sponsor/CRO within 24 hours of 
their awareness of the event according to the procedure outlined below. All fatal or life-threatening SAEs 
should be telephoned to the sponsor/CRO or the authorized representative as soon as the PI learns of the 
event. 
12.3.1.2.6 SERIOUS ADVERSE EVENT REPORTING 
It is the responsibility of the PI to report all SAE occurrences to the sponsor/CRO authorized 
representative within 24 hours of their awareness of the event: 
 
Complete and return an SAE Form with all information known to date; including the PI’s 
assessment of causality. 
 
If the event is fatal or life-threatening, telephone sponsor/CRO or the authorized representative as 
soon as the PI learns of the event. 
 
Obtain and maintain all pertinent medical records (discharge summary, autopsy report, etc.) and 
medical judgments of investigator site staff who assisted in subject’s treatment and follow-up. 
 
Provide follow-up information to the sponsor/CRO or the authorized representative. 
All SAEs will be followed until satisfactory resolution or until the PI deems the event to be chronic or the 
subject is stable.  Other supporting documentation of the event may be requested by the Data 
Coordinating Center/sponsor/CRO and should be provided as soon as possible. 
The sponsor will be responsible for notifying the FDA of any unexpected fatal or life-threatening 
suspected adverse reaction as soon as possible, but in no case later than 7 calendar days after the 
sponsor’s initial receipt of the information.  In addition, the sponsor must notify FDA, and all 
participating investigator sites in an IND safety report, of potential serious risks from clinical studies (or 
any other source) as soon as possible, but in no case later than 15 calendar days after the sponsor 
determines that the information qualifies for reporting. 
Regulatory authorities, IRBs/IEC, and investigator sites will be notified of SAEs in accordance with 
applicable regulations and requirements (e.g., GCPs, ICH Guidelines, national regulations and local 
requirements). 
The PI will collect information on SAEs until subject’s health has returned to baseline, the SAE has 
stabilized, or remaining health issues have otherwise been explained. 

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12.3.1.2.7 REPORTING EVENTS TO SUBJECTS  
The sponsor/CRO will disclose clinical study data to individuals, to investigator sites, and publicly (as 
aggregate summaries) in accordance with regulatory and local legal requirements. 
Follow-up of Non-Serious Adverse Events 
Non-serious AEs that are identified during the last scheduled study visit (or early discontinuation, if 
applicable) must be recorded on the AE CRF as ongoing. 
Any clinically significant abnormal test results, e.g., laboratory findings, at the Week 24/ET visit should 
be followed to resolution or until determined by the PI to be stabilized.  Repeat tests may be indicated to 
establish this. 
If a subject has any clinically significant, trial-related abnormalities at the end of the trial, the medical 
monitor should be notified, and every effort made by the PI to arrange follow up evaluations at 
appropriate intervals to document the course of the abnormalities. 
Follow-up of Post Study Serious Adverse Events 
SAEs that are identified on the last scheduled contact (or early discontinuation, if applicable) must be 
recorded on the AE CRF page and reported to the sponsor/CRO according to the reporting procedures 
outlined in Section 12.3.1.2.6.  This may include unresolved previously reported SAEs, or new SAEs.  
The PI should follow the SAE until it resolves or is determined by the PI to be stable, or the subject is lost 
to follow-up.  The PI should continue to report any significant follow-up information to the medical 
monitor, sponsor/CRO, and the IRB/IEC up to the point the event has resolved or is determined to be 
stable.  Resolution means the subject has returned to the baseline state of health, and stable means the PI 
does not expect any further improvement or worsening of the subject’s condition. 
Any new SAEs reported by the subject to the PI that occur after the last scheduled contact and are 
determined by the PI to be reasonably associated with the administration of IP should be reported to 
sponsor/CRO and the IRB/IEC. 
  
 
 
  
 
 
 
 
 
 
 

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12.3.2 CLINICAL LABORATORY TESTS 
As outlined in the Clinical Laboratory Tests table below, non-fasting samples for hematology, chemistry, 
and urinalysis will be collected at Screening and at Weeks 8 and 24/ET. 
 
  
Blood and urine will be collected using applicable safety precautions and will be processed according to 
the clinical laboratory’s instructions. 
 
 
Hematology 
Chemistry 
Urinalysis 
Additional Tests 
Hemoglobin 
Hematocrit 
Leukocyte count 
(total) 
Leukocyte count 
(differential) 
Red blood cell count 
Platelet count 
Glucose 
Total bilirubin 
Alanine aminotransferase
Aspartate 
aminotransferase 
Alkaline phosphatase 
Blood urea nitrogen 
Sodium 
Potassium 
Chloride 
Calcium 
Carbon Dioxide 
(Bicarbonate) 
Total Protein 
Creatinine 
Specific 
gravity 
pH 
Glucose 
Protein 
Blood 
Bilirubin 
Ketones 
 
 
 
 
 
PT/INR 
It is the PI’s responsibility to review the results of all laboratory tests as they become available.  For each 
laboratory test result outside the reference range, the PI must ascertain if the abnormal lab result is a 
clinically significant result for that individual subject.  Likewise, if laboratory tests are taken at follow-up 

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visits, the PI must ascertain if this is an abnormal and clinically significant change pre-treatment for that 
individual subject.  The PI may repeat the laboratory test or request additional tests to verify the results of 
the original laboratory test.  The PI must sign and date all written laboratory results (e.g., urinalysis, 
hematology, chemistry, and pregnancy tests) and note Not Clinically Significant (NCS) or Clinically 
Significant (CS) for each out of range laboratory value.  Toxicity grading for laboratory results is 
standardized using the FDA’s “Guidance for Industry:  Toxicity Grading Scale for Health Adult and 
Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials” dated September 2007.  If a 
laboratory value is determined to be a clinically significant result for that subject, this may be considered 
an AE to be assessed according to severity.  Refer to Section 12.3.1.2.3 for further information. 
 
 
 
 
12.3.3 12-LEAD ELECTROCARDIOGRAMS (ECGS) 
At screening, re-screening (if applicable), and at Weeks 8 and Week 24/ET, a single standard supine 12-
lead ECG will be obtained after a subject has rested quietly for at least 5 minutes.  The ECG data will be 
submitted to a central reader for measurement.  Instructions for the collection, transmission, and archiving 
of the ECG data are outlined in the ECG central reader manual.  The analyzed ECG data will be reviewed 
and signed by the PI. 
12.3.4 INJECTION SITE EVALUATION 
The injection site evaluation will be a global evaluation of the injection site. 
Injection Site Evaluation 
Assessment Descriptor 
Present? 
Yes 
No 
Erythema 
 
 
Edema 
 
 
Burning or Stinging (sensation as described by 
subject) 
 
 
Itching (sensation as described by subject) 
 
 
Bruising 
 
 
Drainage 
 
 
12.3.5 HYPERSENSITIVITY EVALUATION 
The following skin reactions may indicate hypersensitivity during injection site evaluation: 
 
Erythema 
 
Wheal(s) 

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 
Pruritus 
 
Warmth at the injection site 
An additional blood draw should be performed in order to address immediate hypersensitivity concerns.  
Revance recommends that at least 2 of the 4 above-listed symptoms should be present to make this 
clinical diagnosis.  The investigator should also use his/her clinical judgment in addition to the 
aforementioned guidelines. 
12.3.6 PHYSICAL EXAMINATIONS 
Physical examination will include neurological examination; the PE will include examination of the face, 
general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, heart, lungs, abdomen, lymph 
nodes, and extremities. Urogenital exam need only be completed if clinically indicated.  At post-treatment 
visits, the physical examination may be abbreviated, as deemed medically appropriate at the discretion of 
the PI; the neurological examination must be conducted at a minimum.  Significant physical examination 
findings that are present prior to IP administration are to be included on the Medical History page. 
Significant physical examination findings which meet the definition of an AE will be recorded on the AE 
page post-treatment.  
12.3.7 FOOT AND ANKLE EXAMINATION 
Examination for the foot will be conducted, including ankle, toe, and subtalar range of motion, foot motor 
strength, location of pain, and examination of the heel fat pad and Tinel’s sign.  The presence of toe 
deformities, bunions, ulcers, and/or sores will be documented.  The feet will be examined for signs of 
swelling, pitting edema, infection, or vascular abnormalities (refer to APPENDIX A). 
12.3.8 HEIGHT, WEIGHT, VITAL SIGNS 
Height, weight, and vital signs (i.e., body temperature, respiration rate, sitting radial pulse rate, and sitting 
systolic and diastolic BP) will be obtained.  Height will only be collected at the Screening visit.   
12.3.9 COLUMBIA-SUICIDE SEVERITY RATING SCALE 
The C-SSRS monitors changes in suicidal thinking and behavior over time, in order to determine risk 
(Posner, 2011; APPENDIX H).  The following four constructs are measured: the severity of ideation, the 
intensity of ideation, behavior, and lethality.  
The C-SSRS will be used to assess suicidal ideations and behaviors.  The C-SSRS results for each subject 
should be reviewed by the PI at each visit.  If at any time the C-SSRS results for a given subject reveal 
potential suicidality, then the PI should assess the clinical significance of such results.  If a clinically 
significant risk of suicidality is identified for a subject, then the PI should discontinue the subject and 
implement appropriate treatment.  
12.3.10 
REPORTING OF PREGNANCY  
During the trial, all WOCBP should be instructed to contact the investigator site immediately (within 
24 hours) if they suspect they might be pregnant (e.g., missed or late menstrual cycle).  The PI must 
immediately notify sponsor/CRO of any female subject who becomes pregnant any time during study 

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participation, record the information on the Pregnancy Notification Form and send the form to the CRO.  
The investigator site will be asked to follow-up with the subject periodically during the pregnancy for 
ongoing health and safety information through term, as applicable.  Subjects will remain on the study. 
12.3.11 
PREGNANCY TESTING 
All WOCBP will have a SPT at the Screening, Week 8 and 24/ET visits and a UPT at the Day 1 
Treatment Visit pre-treatment.  If any result is positive prior to treatment, the subject will not be allowed 
to participate.  The results of the UPTs for WOCBP will be evaluated at the investigator site.  
WOCBP must use an effective method of birth control during the course of the trial, such as the oral 
contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal 
ligation, barrier method used WITH an additional form of contraception (e.g., sponge, spermicide or 
condom), abstinence, no heterosexual intercourse, or has a vasectomized partner.  A female is considered 
to be of childbearing potential UNLESS she is post-menopausal (no menses for 12 consecutive months) 
or without a uterus and/or both ovaries. 
Before enrolling WOCBP in this clinical trial, the PI or designee must review guidelines about study 
participation for WOCBP. The topics should generally include: 
 
Informed consent document 
 
Pregnancy prevention information 
 
Risks to unborn child(ren) 
 
Any drug interactions with hormonal contraceptives 
 
Contraceptives in current use 
 
Guidelines for the follow-up of a reported pregnancy 
Prior to study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during 
participation in this clinical study and the potential risk factors for an unintentional pregnancy.  The 
subject must sign the informed consent document stating that the above-mentioned risk factors and the 
consequences were discussed with her. 
12.3.12 
IMAGING 
X-rays or sonography of the affected foot will be collected at Screening.  This procedure is to be done at 
the investigator site. Records of the imaging are to be collected and kept with the subject’s study 
information.  In the event a subject has had imaging of the affected foot within the 6 months prior to 
Screening, the subject does not need to have imaging conducted as part of the Screening procedure if the 
image is available for evaluation by the investigator at the time of Screening to determine eligibility. 
12.4 UNANTICIPATED ADVERSE EVENTS 
12.4.1 DEFINITION OF UNANTICIPATED ADVERSE EVENTS 

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The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
subjects or others to include, in general, any incident, experience, or outcome that meets all of the 
following criteria: 
 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures that are 
described in the protocol-related documents, such as the Institutional Review Board (IRB)-
approved research protocol and informed consent document; and (b) the characteristics of the 
subject population being studied; 
 
Related or possibly related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been caused by the 
procedures involved in the research); and 
 
Suggests that the research places subjects or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized 
The sponsor/CRO will comply with these criteria for reporting unanticipated AEs. 
12.4.2  UNANTICIPATED ADVERSE EVENT REPORTING  
The investigator site will report unanticipated AEs to the reviewing Institutional Review Board (IRB) and 
the sponsor/CRO. The unanticipated AE report will include the following information: 
 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
 
A detailed description of the event, incident, experience, or outcome;  
 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an unanticipated AE;  
 
A description of any changes to the protocol by the sponsor/CRO or other corrective actions that 
have been taken or are proposed in response to the unanticipated AE. 
 
The sponsor/CRO will update the IB or provide Dear Doctor letter should these actions be 
deemed required.  
To satisfy the requirement for prompt reporting, unanticipated AEs will be reported using the following 
timeline:   
 
Unanticipated AEs that are fatal and life-threatening SAEs will be reported to the IRB and to the 
sponsor/CRO within seven (7) days of the PI becoming aware of the event.  
 
Any other unanticipated AEs that are SAEs will be reported to the IRB and to the sponsor/CRO 
within 15 days of the PI becoming aware of the problem.  
 
All unanticipated AEs that non-serious AEs are not required to be reported to the IRB or to the 
sponsor/CRO.  
 
All unanticipated SAEs should be reported to appropriate institutional officials (as required by an 

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institution’s written reporting procedures), the supporting agency head (or designee), and the 
OHRP if applicable.  
 
All SUSARs will be reported in compliance with the requirements of the respective Regulatory 
Authority. 
12.4.3 REPORTING UNANTICIPATED ADVERSE EVENTS TO SUBJECTS  
The sponsor/CRO will disclose clinical study data to individuals, to investigator sites, and publicly as 
aggregate summaries, in accordance to Regulatory and local legal requirements. 
13 STATISTICAL CONSIDERATIONS 
13.1 SAMPLE SIZE DETERMINATION 
The sample size calculations are based on the minimal clinically important difference of 2 points for 
NPRS (Farrar, 2001; Michener, 2011).  
 
 
 
 
 
 
 
 
 
 
13.2 POPULATIONS FOR ANALYSES 
Approximately 150 subjects, 18 to 65 years of age, will be randomized 
 
   
 
Intent-to-Treat (ITT) Population: Efficacy analysis will be performed using the ITT 
population, which includes all subjects randomized who received study treatment, with treatment 
arms classified based on randomization assignment, regardless of the actual treatment received.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

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13.3 STATISTICAL ANALYSES 
13.3.1 GENERAL CONSIDERATIONS 
All evaluable efficacy data will be included in the analysis following the ITT principle.  
13.3.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT 
The primary endpoint is: 
 
Change from baseline in the NPRS score, which is recorded within 15 minutes after stepping out 
of bed in the morning and averaged over 5 days (defined as 4 days prior to the study visit and on 
the study visit day) at Week 8.  For the primary analysis, missing data will be imputed by the 
multiple imputation approach. Analysis of covariance (ANCOVA) model will be used, including 
investigator site and treatment group as factors, and baseline NPRS score as a covariate.  
Analysis of the primary efficacy endpoint will be based on the ITT or treatment policy estimand 
and is fully defined in the Statistical Analysis Plan (SAP).  

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Laboratory results and vital sign data will be summarized by visit and treatment arm, using descriptive 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
  
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 

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13.3.11 
SUB-GROUP ANALYSES 
Sub-group analysis will be presented in the SAP, if appropriate.  
13.3.12 
TABULATION OF INDIVIDUAL SUBJECT DATA 
Individual subject data will be listed by measure and time point at completion of the study. 
14 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
14.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
14.1.1 INFORMED CONSENT PROCESS 
14.1.1.1 INFORMED CONSENT AND AUTHORIZATION TO RELEASE HEALTH 
INFORMATION 
Written informed consent will be obtained from all subjects before any study-related procedures 
(including any screening procedures) are performed.  The PI may discuss the study and the possibility for 
entry with a potential subject without first obtaining consent.  However, a subject wishing to participate 
must give written informed consent prior to any study-related procedures being conducted, including 
those performed solely for the purpose of determining eligibility for study participation, and including 
withdrawal from current medication (if required prior to study entry).  The PI has both the ethical and 
legal responsibility to ensure that each subject being considered for inclusion in this study has been given 
a full explanation of the procedures and expectations for study participation. 
Investigator site-specific informed consent form templates must be forwarded to the sponsor/CRO for 
approval prior to submission to an IRB/Independent Ethics Committee (IEC) that is registered with the 
US Department of Health and Human Services (HHS) or applicable health authority.  Each subject will 
sign the consent form that has been approved by the same IRB/IEC that was responsible for protocol 
approval.  Each informed consent document must adhere to the ethical principles stated in the Declaration 
of Helsinki and will include the elements required by FDA regulations in 21 CFR Part 50, as well as the 
elements required by the ICH GCP guideline, and applicable federal and local regulatory requirements.  
The consent form must also include a statement that the sponsor/CRO, their designees, and auditing 
regulatory agencies will have direct access to the subject’s records and medical history for study related 
purposes. 
Once the appropriate essential information has been provided to the subject and fully explained by the PI 
(or a qualified designee) and it is felt that the subject understands the implications and risks of 
participating in the trial, the IRB/IEC approved consent document shall be signed and dated by both the 
subject and the person obtaining consent (PI or designee), and by any other parties required by the 
IRB/IEC or other regulatory authorities.  The subject will be given a copy of the signed informed consent 
document with the original maintained in the blinded ISF by the PI.  All of the above activities must be 
completed before any study related procedures are conducted (including any screening study procedures). 
14.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 

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Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation.  Consent forms will be IRB-approved and 
the subject will be asked to read and review the document.  The PI will explain the research study to the 
subject and answer any questions that may arise.  A verbal explanation will be provided in terms suited to 
the subject’s comprehension of the purposes, procedures, and potential risks of the study and of their 
rights as research subjects.  Subjects will have the opportunity to carefully review the written consent 
form and ask questions prior to signing.  The subject should have the opportunity to discuss the study 
with their family or surrogates or think about it prior to agreeing to participate.  The subject will sign the 
informed consent document prior to any procedures being done specifically for the study.  Subjects must 
be informed that participation is voluntary and that they may withdraw from the study at any time, 
without prejudice.  A copy of the informed consent document will be given to the subjects for their 
records.  The informed consent process will be conducted and documented in the source document 
(including the date), and the form signed, before the subject undergoes any study-specific procedures.  
The rights and welfare of the subjects will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study.   
14.1.1.3 STUDY DISCONTINUATION AND CLOSURE.   
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to subjects, investigator sites, the IND sponsor and regulatory 
authorities.  If the study is prematurely terminated or suspended, the PI will promptly inform subjects, the 
IRB, and sponsor/CRO and will provide the reason(s) for the termination or suspension.  Subjects will be 
contacted, as applicable, and be informed of changes to study visit schedule. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to subjects 
 
Insufficient compliance to protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination of futility 
The study may resume once concerns about safety, protocol compliance, and data quality are addressed, 
and satisfy the sponsor/CRO, IRB and/or FDA. 
  
 
 
 
 
 
  
 
  
  

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14.1.5  SAFETY MONITORING/DATA MANAGEMENT 
An Independent Data Monitoring Committee (DMC) will be appointed to review safety data during the 
study.  Details of the composition and scope of the committee’s mandate will be presented in a DMC 
charter document. The DMC will evaluate all safety data available at timepoints specified in the charter 
and will make appropriate recommendations.  
14.1.6 MONITORING, COMPLIANCE, AND QUALITY 

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All aspects of the study will be monitored by the sponsor/CRO according to GCP and SOPs for 
compliance with applicable government regulations, (i.e., Informed Consent Regulations and Institutional 
Review Board regulations).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

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14.1.7.1  DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
14.1.7.1.1 DATA COLLECTION 
For this trial, all protocol-specified data recorded in the source documents will be entered on the CRFs 
from the source documents.  Subject assessments will be completed by the individual subjects directly on 
the corresponding CRFs.  In addition to signature confirmation that a subject meets the study eligibility 
criteria, upon each subject’s completion of the trial, the PI will sign a statement indicating that all pages 
of the subject’s case report have been reviewed.  Signature stamps and “per signatures” are not 
acceptable.  
It is the sponsor/CRO’s policy that the study data be verifiable with the source data that necessitates 
access to all original recordings, laboratory reports, and other records for each subject.  The PI must 
therefore agree to allow access to subjects’ records, and source data must be made available for all study 
data.  Subjects (or their legal representatives) must also allow access to their medical records.  Subjects 
will be informed of the importance of increased record access and permission granted by signature on the 
informed consent document prior to Screening. 
Checks will be performed to ensure the quality, consistency, and completeness of the data.  Instances of 
missing or un-interpretable data will be resolved with the PI or Study Coordinator.  Data queries will be 
sent to the investigator site. Investigator site staff will be responsible for providing resolutions to the data 
queries and for correcting the CRFs, as appropriate. 
The PI must keep written or electronic source documents for every subject participating in the clinical 
study.  Source documentation must include subject demographic and medical information including but 
not limited to:  
 
Date of birth 
 
Sex 
 
Race 
 
Ethnicity 
 
Medical history 
 
Comorbid conditions 
 
Concomitant therapies/medication 
 
Study visit dates 
 
Performed examinations, evaluations, and clinical findings 
 
IP administration 
 
AEs, SAEs, or pregnancy (as applicable) 
Additionally, any other documents with source data, especially original printouts of data that were 
generated by technical equipment must be included in the subject’s source document (e.g., laboratory 
value listings).  All these documents must have at least the subject’s initials, study number, and the date 
of the evaluation.  

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The data recorded during the course of the study will be documented in the CRF and/or the trial-specific 
forms.  Before or at study termination, all data must be forwarded to the sponsor/CRO.  The data will then 
be recorded, evaluated, and stored in anonymous form in accordance with data-protection regulations. 
Subjects will authorize the use of their protected health information during the informed consent process 
in accordance with the applicable privacy requirements.  Subjects who deny permission to use and 
disclose protected health information will not be eligible to participate in the study.  The PI will ensure 
that the study documents forwarded to the sponsor/CRO, and any other documents, contain no mention of 
subject names. 
Any amendments and corrections necessary will be undertaken in both the source documents and CRFs 
(as appropriate) and countersigned by the PI, or documented designee, stating the date of the 
amendment/correction.  Errors must remain legible and may not be deleted with correction aids.  The PI 
must state his/her reason for the correction of any data.  In the case of missing data/remarks, the entry 
spaces provided in the CRF should be cancelled out so as to avoid unnecessary follow-up inquiries. 
Regulatory authorities, the IRB/IEC and/or the sponsor/CRO’s Quality Assurance group (or designee) 
may request access to all source documents, CRFs, and other study documentation for on-site audit or 
inspection.  The PI must guarantee direct access to these documents.  CRFs will be kept by the 
sponsor/CRO or an authorized designee in a secured area. Clinical data will be recorded in a computer 
format for subsequent statistical analyses.  Data files will be stored on electronic media with a final 
master data file kept by the sponsor/CRO after descriptive and statistical analyses and reports have been 
generated and are complete. 
14.1.7.1.2 FILE MANAGEMENT AT THE INVESTIGATOR SITE 
It is the responsibility of the PI to ensure that their blinded and unblinded ISF is maintained in accordance 
with ICH Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance, Section 8 – Essential 
Documents for the Conduct of a Clinical Trial. Documentation is subject to inspection by the sponsor and 
relevant regulatory agencies. 
14.1.7.2  RECORDS RETENTION AT THE INVESTIGATOR SITE 
It is a sponsor/CRO requirement that all PIs participating in clinical studies maintain detailed clinical data 
for 1 of the following periods: 
 
Country-specific requirements, or 
 
A period of at least 2 years following the last approval of a marketing application approved by a 
Regulatory Authority in an ICH region or until there are no pending or contemplated marketing 
applications in an ICH region, or, 
 
A period of 2 years after the sponsor/CRO notifies the PI that the data will not be submitted for 
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14.1.7.3 TREATMENT OF MISSING DATA 
Some data elements will be missing in this study due to subjects who withdraw from the study, subjects 
who are lost to follow-up, or subjects who do not complete all study visits.  The completion status of each 
subject will be documented (e.g., completed protocol, withdrew from study, lost to follow-up, etc.).  
All reasonable efforts will be made by the investigator site staff to maintain contact with the subjects 
during their participation in the study.  The study coordinator will attempt to contact any subjects who are 
lost to follow-up.  For subjects who are unwilling to return to clinic for follow-up, the study coordinator 
will attempt to contact them and to collect study data from them during a telephone call or by forms sent 
to them through the mail. 
14.1.8 PROTOCOL DEVIATIONS  
This study will be conducted as described in this protocol, except for an emergency situation in which the 
protection, safety, and well-being of the subject requires immediate intervention, based on the judgment 
of the PI (or a responsible, appropriately trained professional designated by the PI).   
In the event of a significant deviation from the protocol due to an emergency, accident, or mistake, the PI 
or designee must contact the sponsor/CRO at the earliest possible time by telephone.  This will allow an 
early joint decision regarding the subject’s continuation in the study.  This decision will be documented 
by the PI and the sponsor/CRO. It is the responsibility of the PI and/or designated investigator site 
personnel to report significant protocol deviations to the IRB/IEC per their institutional procedures. 
Y 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 

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14.2 ADDITIONAL CONSIDERATIONS 
14.2.1 ETHICS AND RESPONSIBILITY 
This study must be conducted in compliance with the protocol, the ICH Guidance for Industry E6 Good 
Clinical Practice: Consolidated Guidance and the applicable regulatory requirements.  PIs must submit all 
essential regulatory documentation, as required by local and national regulations (including approval of 
the protocol and informed consent form by an HHS-registered IRB/IEC) to the sponsor/CRO before IP 
will be shipped to the investigator site. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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