A Phase 2, Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis
Phase: PHASE2
Conditions: Plantar Fasciitis
Sponsor: Revance Therapeutics, Inc.

 
Revance Therapeutics, Inc. 
Confidential 
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A PROSPECTIVE, RANDOMIZED, DOUBLE-
BLINDED, PLACEBO-CONTROLLED TRIAL OF 
DAXIBOTULINUMTOXINA FOR INJECTION 
FOR THE MANAGEMENT OF PLANTAR 
FASCIITIS 
Protocol Number: 1720201 
National Clinical Trial (NCT) Identified Number: NCT03137407  
Sponsor: Revance Therapeutics, Inc. 
Version Number: 4.0 
14 Dec 2017 
 

DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
Version 4.0, Amendment 3 
Protocol 1720201 
14 Dec 2017 
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Confidential 
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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
Version 4.0, Amendment 3 
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Revance Therapeutics, Inc. 
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DaxibotulinumtoxinA for Injection for Plantar Fasciitis 
Version 4.0, Amendment 3 
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INVESTIGATOR’S AGREEMENT 
I have carefully read the protocol entitled: “A Prospective, Randomized, Double-Blinded, 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 to the trial personnel under my supervision. I will discuss this material with them 
to ensure that they are fully informed about the investigational drug and the trial protocol. 
I agree to conduct this clinical trial 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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Table of Contents 
STATEMENT OF COMPLIANCE .............................................................................................................. 1 
1 
PROTOCOL SUMMARY ................................................................................................................ 2 
1.1 
Synopsis ................................................................................................................................... 2 
 
 
 
 
2 
INTRODUCTION ............................................................................................................................. 7 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 12 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................. 14 
4 
STUDY DESIGN ............................................................................................................................ 15 
4.1 
Overall Design ....................................................................................................................... 15 
 
 
 
 
 
5 
4.5 
Duration of Trial .................................................................................................................... 15 
 
 
4.7 
End of Study Definition ......................................................................................................... 16 
5 
STUDY POPULATION .................................................................................................................. 17 
5.1 
Inclusion Criteria ................................................................................................................... 17 
5.2 
Exclusion Criteria .................................................................................................................. 17 
5.3 
Lifestyle Considerations ........................................................................................................ 18 
 
 
5.4 
Screen Failures....................................................................................................................... 19 
5.5 
Strategies for Recruitment and Retention .............................................................................. 19 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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5 
6.6 
Concomitant Therapy ............................................................................................................ 25 
6.6.1 
Rescue Medicine .................................................................................................. 26 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ................................................................................................... 27 
7.1 
Discontinuation of Study Intervention ................................................................................... 27 
7.2 
Early Discontinuation/Withdrawal Procedures ..................................................................... 27 
7.3 
Lost to Follow-Up .................................................................................................................. 27 
8 
STUDY ASSESSMENTS AND PROCEDURES .......................................................................... 29 
8.1 
Study Assessments ................................................................................................................. 29 
8.1.1 
Screening Visit ..................................................................................................... 29 
8.1.2 
Injection Visit ...................................................................................................... 29 
8.1.3 
Follow-Up Visits.................................................................................................. 30 
8.2 
Efficacy Assessments ............................................................................................................ 31 
8.3 
Safety and Other Assessments ............................................................................................... 32 
8.4 
Adverse Events and Serious Adverse Events ........................................................................ 34 
8.4.1 
Definition of Adverse Events (AE)...................................................................... 34 
8.4.2 
Definition of Serious Adverse Events (SAE) ...................................................... 35 
8.4.3 
Classification of an Adverse Event ...................................................................... 35 
8.4.4 
Time Period and Frequency for Event Assessment and Follow-Up .................... 36 
8.4.5 
Adverse Event Reporting ..................................................................................... 37 
8.4.6 
Serious Adverse Event Reporting ........................................................................ 37 
8.4.7 
Reporting Events to Participants .......................................................................... 37 
8.4.8 
Follow-up of Non-Serious Adverse Events ......................................................... 37 
8.4.9 
Follow-up of Post Trial Serious Adverse Events ................................................. 38 
 
 
8.4.11 
Reporting of Pregnancy ....................................................................................... 40 
8.5 
Unanticipated Adverse Events ............................................................................................... 40 
8.5.1 
Definition of Unanticipated Adverse Events ....................................................... 40 
8.5.2 
Unanticipated Adverse Event Reporting ............................................................. 40 
8.5.3 
Reporting Unanticipated Adverse Events to Participants .................................... 41 
9 
STATISTICAL CONSIDERATIONS ............................................................................................ 42 
9.1 
Statistical Hypothesis ............................................................................................................. 42 
9.2 
Sample Size Determination ................................................................................................... 42 
9.3 
Populations for Analyses ....................................................................................................... 42 
9.4 
Statistical Analyses ................................................................................................................ 42 
9.4.1 
General Approach ................................................................................................ 42 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) ..................................................... 43 
 
 
9.4.4 
Safety Analyses.................................................................................................... 43 
9.4.5 
Baseline Descriptive Statistics ............................................................................. 43 
 
 

 
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10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .................. 45 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ..................................................... 45 
10.1.1 
Informed Consent Process ................................................................................... 45 
10.1.2 
Study Discontinuation and Closure ..................................................................... 46 
 
 
 
 
 
 
10.1.6 
Safety Monitoring/Data MAnagement Committee .............................................. 47 
10.1.7 
Monitoring, Compliance, and Quality ................................................................. 47 
10.1.8 
Data Quality Assurance Audits and Quality Control ........................................... 48 
10.1.9 
Data Handling and Record Keeping .................................................................... 48 
10.1.10 
Protocol Deviations.............................................................................................. 50 
 
 
 
 
10.2 
Additional Considerations ..................................................................................................... 51 
10.2.1 
Ethics and Responsibility ..................................................................................... 51 
 
 
10.3 
Abbreviations ......................................................................................................................... 53 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STATEMENT OF COMPLIANCE 
 
The trial will be conducted in accordance with International Council for Harmonisation Good Clinical 
Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations (CFR) Terms and 
Conditions of Award. The Principal Investigator 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 the trial participants. 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 participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form must 
be obtained before any participant is enrolled. 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 participants who provided consent, using a previously approved consent form. 

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1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial of 
DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis 
Study Description: 
Treatment with DaxibotulinumtoxinA for Injection (Daxi for Injection) of 
plantar fascia and plantar muscles combined with transient and selective 
partial paralysis of gastrocnemius/soleus complex (dysfunction) and a 
simple home program and inexpensive splinting will ameliorate signs and 
symptoms of plantar fasciitis; will improve function, and will optimize 
health related quality of life. 
Objectives: 
 
Primary Objective:  
 
To compare the safety and efficacy of DaxibotulinumtoxinA for 
Injection versus placebo for managing plantar fasciitis 
 
  
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Population: 
Male and female adult subjects who have plantar fasciitis that has not 
responded to conservative treatment modalities. 
Phase: 
2  
Description of 
Sites/Facilities 
Enrolling Participants: 
Up to 5 sites in the United States (US) will participate in the study. 
Approximately 60 subjects will be enrolled. 
 
 
 
 
 
 

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Study Duration: 
Approximately eight (8) months 
Participant Duration: 
The study duration for each participant is up to approximately five (5) 
months (up to four [4] weeks for Screening, a single day of Treatment, and 
up to 16 weeks of Follow-up). 
 
 

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2 
 
INTRODUCTION 

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3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
To compare the safety and efficacy 
of DaxibotulinumtoxinA for 
Injection versus placebo for 
managing plantar fasciitis 
 
Reduction in the visual analog 
scale (VAS) for pain for the foot at 
Week 8 
Clinically relevant 
outcome measure for 
this indication 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4 
STUDY DESIGN  
4.1 
OVERALL DESIGN 
The study is designed as a prospective, randomized, placebo-controlled, double-blinded clinical trial to 
compare DaxibotulinumtoxinA for Injection and placebo injections for the management of plantar 
fasciitis signs and symptoms. 
4.5 
DURATION OF TRIAL 
The study duration for each participant is up to approximately five (5) months (up to four [4] weeks for 
Screening, a single Injection day, and up to 16 weeks of Follow-up). 
 

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4.7 
END OF STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed all visits of the study 
including the last visit or the last scheduled procedure shown in Section 1.3, Schedule of Assessments. 
The end of the study is defined as completion of the last visit or procedure shown in the SoA in the trial 
globally. 

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5 
STUDY POPULATION  
5.1 
INCLUSION CRITERIA 
All subjects must meet the following inclusion criteria: 
1. Written informed consent, including authorization to release health information 
2. Male or female subjects 18 to 65 years of age with diagnosis of unilateral plantar fasciitis by 
physical examination and/or ultrasonography 
3. Unilateral plantar fasciitis as defined as no symptoms or signs in the contralateral foot and no 
sought medical attention in the contralateral foot within three (3) months of diagnosis 
4. Persistent heel pain for more than three (3) months (such as pain with walking, pain 
interfering with quality of life, pain > 45/100 on the VAS for pain in the morning) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subjects will not be enrolled if they meet any of the following exclusion criteria: 
1. Previous injections of botulinum toxins in the lower extremities or feet 
2. Entrapment of the posterior tibial, lateral plantar, or medial plantar nerve (local nerve 
entrapment) 
3. Fixed hindfoot varus 
4. Posterior tibial tendon dysfunction 
5. Severe pes planus 
6. Midfoot collapse 
7. Significant talar or navicular callus 
8. Tarsal coalition or rigid flatfoot 
9. Systemic disease associated with foot pain 
10. Sciatica 
11. Severe osteoarthritis of the forefoot, midfoot, or ankle 

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12. Use of antibiotics that may interfere with neuromuscular junction function, for example, 
aminoglycoside antibiotics (e.g., gentamicin sulfate, fradiomycin sulfate), polypeptide 
antibiotics (e.g., polymixin B sulfate), tetracycline antibiotics, and lincomycin antibiotics, 
except for those contained in topical antimicrobials, three (3) days prior to treatment and three 
(3) days post-treatment  
13. Peripheral vascular disease 
14. Rheumatoid arthritis 
15. Insulin dependent diabetes mellitus 
16. Previous surgery on the midfoot or hindfoot 
17. Hypertonicity 
18. Neuromuscular disease 
19. Systemic muscle weakness 
20. Fibromyalgia 
21. Allergy or hypersensitivity to any components of the study treatments 
22. Comorbidities that confound the evaluation of the feet 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
5.3 
LIFESTYLE CONSIDERATIONS 
 
 
 
 

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5.4 
SCREEN FAILURES 
A screen failure subject will be a person from whom informed consent is obtained and is documented in 
writing (i.e., subject signs an informed consent form), but who does not meet the study eligibility 
requirements.  
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Adult male and female subjects who have been diagnosed with plantar fasciitis that have not responded to 
conservative treatment modalities for three (3) months as per the PI’s discretion will be enrolled in these 
clinical trials. 
All subjects who present with plantar fasciitis who meet the study inclusion/exclusion criteria found in 
Sections 5.1 and 5.2 will be asked to participate in the study. If subjects agree to participate and provide 
informed consent, they will be enrolled in the study and randomized to one (1) of the two (2) study 
treatments, DaxibotulinumtoxinA for Injection or placebo. 

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Sites selected are those known to have a patient population being treated for plantar fasciitis. Selected 
sites will also receive referrals of potential subjects for this study via their respective physician network as 
appropriate. Subject recruiting materials is provided to all sites. In addition, selected Clinical Research 
Organization (CRO) is supporting sites in managing subject recruitment.  
Subject retention will include regular study visits with the Investigator and site staff. A minimal 
acceptable stipend is provided to enrolled subjects for travel and time. Selected CRO will also work with 
Sponsor in developing an appropriate subject retention plan.  
 

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6.6 
CONCOMITANT THERAPY 
Concomitant medications are any prescription or over-the-counter preparations used by subjects during 
participation in the trial. Use of concomitant medications will be recorded on the Concomitant 
Medications case report form (CRF) beginning at the Screening Visit until the Week 16/Early 
Termination visit. 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. 

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Standardized home therapy program including Achilles tendon and plantar fascia stretching exercises 
and night splints will also be recorded throughout the study. 
6.6.1 RESCUE MEDICINE 
The Sponsor will not allow any type of rescue medication in this clinical study for the treatment of plantar 
fasciitis. Subject(s) may withdraw from the study at any time if rescue medication is required.  
 

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7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
Study subjects will receive a one (1) 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 7.2, for more 
details.  
If a clinically significant finding is identified (including, but not limited to changes from baseline) after 
enrollment, the Investigator or qualified designee will determine if any change in participant management 
is needed. Any new clinically relevant finding will be reported as an adverse event (AE). 
7.2 
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 Investigator will attempt to determine the reason for discontinuation 
and record the reason in the subject’s trial records and on the case report form (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 the Final Evaluation) and whenever possible, the subject 
should be asked to return to the trial center to complete the assessments specified in the Week 16/Early 
Termination visit. Subjects who withdraw from the trial will not be replaced. 
If at any time during the trial, the Investigator determines that it is not in the best interest of the subject to 
continue, the subject will be discontinued from participation. The Investigator can discontinue a subject 
from study participation at any time if medically necessary or if the subject has failed to follow trial 
procedures or to keep follow-up appointments. Appropriate documentation in the subject’s trial record 
and CRF regarding the reason for discontinuation must be completed. Prior to discontinuing a subject 
from study participation, the Investigator will discuss his/her intentions with the Medical Monitor or 
designee. 
All subjects who fail to return to the trial center 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 trial. If a subject is unreachable by telephone after a minimum of two (2) 
documented attempts (one [1] attempt on two [2] different days), a registered letter will be sent requesting 
that contact be made with the Investigator.  
Revance has the right to terminate or to stop the trial at any time. Should this be necessary, both Revance 
and the Investigator will ensure that proper study discontinuation procedures are completed 
7.3 
LOST TO FOLLOW-UP 
A participant 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 the study site staff.  
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 

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 
The site will attempt to contact the participant and reschedule the missed visit(s) and counsel the 
participant on the importance of maintaining the assigned visit schedule and ascertain if the 
participant wishes to and/or should continue in the study. 
 
Before a participant is deemed lost to follow-up, the Investigator or designee will make every 
effort to regain contact with the participant (where possible, three (3) telephone calls and, if 
necessary, a certified letter to the participant’s last known mailing address or local equivalent 
methods). These contact attempts should be documented in the participant’s medical record or 
study file.  
 
Should the participant 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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8 
STUDY ASSESSMENTS AND PROCEDURES 
8.1 
STUDY ASSESSMENTS 
All clinical laboratory assessments will be conducted locally at the clinical site facilities. 
8.1.1 SCREENING VISIT 
Subjects presenting with heel pain will be examined to verify the diagnosis of plantar fasciitis. Then, 
subjects with plantar fasciitis will be screened to determine if they meet the study eligibility criteria. 
Prospective study participants will be informed of the study, and the requirements for study participation 
will be explained to them. Subject informed consent must be obtained prior to conducting screening 
procedures. Refer to Section 1.3 Schedule of Assessments, for activities to be performed. 
After the informed consent is obtained, the following procedures will be completed: 
 
Physical examination 
 
Foot and Ankle Examination of both feet (including range or motion and motor strength) 
 
Collect vital signs (blood pressure [BP], pulse, temperature), weight, and height 
 
Collect blood samples for clinical laboratory (chemistry, hematology, urinalysis), 
 
 
 
Collect ECG if not done within the last six (6) months 
 
Collect X-rays if not done within the last six (6) months 
 
Collect concomitant medications/therapies, medical history information 
 
VAS for pain for the foot to be completed by subject 
The Foot and Ankle Examination is developed by Dr. L. Andrew Koman at Wake Forest Baptist Medical 
Center (WFBMC) to document a visual inspection of the foot as well as a thorough foot examination. 
Results from clinical laboratory tests and cardiologist-interpreted ECG must be obtained, reviewed, and 
signed by the Investigator. Any abnormal results must be determined to be not clinically significant by the 
Investigator prior to randomization. Any WOCBP having a positive pregnancy test pre-treatment will not 
be treated. 
8.1.2 INJECTION VISIT 
The following procedures will be completed pre-treatment:  
 
Physical examination 
 
 
 
Collect vital signs (blood pressure [BP], pulse, temperature) and weight 
 
   
 
 
 
  
 
 

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 
Confirm subject eligibility.  
 
 
 
 
 
 
 
 
  
 
 
 
8.1.3 FOLLOW-UP VISITS  
Subjects will be evaluated five (5) times after their injection at Weeks 1, 2, 4, 8, and 16 or any time 
subjects terminate prematurely. Acceptable study visit windows can be ±3 days. The following 
procedures will be completed at each follow-up visits:  
 
 
 
 
 
Collect vital signs (blood pressure [BP], pulse, temperature) and weight 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
 
 
 
 
 
Collect concomitant medications/therapies and adverse event(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, 2, 4, 8, 16 
+/- 3 days 
8.2 
EFFICACY ASSESSMENTS  
Visual Analog Scale (VAS) for Pain: The pain VAS is a continuous scale self-completed by the 
respondent comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) 
in length, anchored by two (2) verbal descriptors, one (1) for each symptom extreme. Instructions, time 
period for reporting, and verbal descriptor anchors have varied widely in the literature depending on 
intended use of the scale. 
For pain intensity, the scale is most commonly anchored by “no pain” (score of 0) and “pain as bad as it 
could be” or “worst imaginable pain” (score of 100 [100-mm scale]). The respondent is asked to place a 
line perpendicular to the VAS line at the point that represents their pain intensity. 
(http://onlinelibrary.wiley.com/doi/10.1002/acr.20543/full)  
American Orthopaedic Foot and Ankle Score (AOFAS): The American Academy of Orthopaedic 
Surgeons developed several musculoskeletal outcomes instruments to collect subject based data to use to 
assess the effectiveness of treatments and to study the clinical outcomes of the treatments. The AOFAS 
foot and ankle questionnaire was designed for use in subjects 18 years old and older. This questionnaire 
documents subject assessments of foot and ankle conditions and improvements resulting from treatments. 
Disability indices for the lower limb core, global foot and ankle function, and shoe comfort can be 
evaluated using this instrument. The questionnaire requires about 10 minutes to complete. 
Foot and Ankle Disability Index (FADI): The FADI contains 34 questions divided into two (2) 
subscales: the Foot and Ankle Disability Index and the Foot Ankle Disability Index Sport (Martin, 1999). 
Each of the questions is scored using a five-point Likert Scale from 0 (unable to do) to 4 (no difficulty at 
all). The FADI was designed to collect information from subjects regarding their functional limitations 
related to their feet and ankles. The FADI Sports module is a population specific subscale designed for 
athletes. The questionnaire requires five (5) to seven (7) minutes to complete. 
The Patient Reported Outcomes Measurement Information System (PROMIS): The PROMIS is a 
system of highly reliable, precise measures of subject–reported health status for physical, mental, and 
social well–being (http://www.nihpromis.org/). PROMIS tools measure what subjects are able to do and 
how they feel by asking questions. PROMIS measures can be used across a wide variety of chronic 
diseases and conditions in clinical studies of the effectiveness of treatment. 
Plantar fasciitis pain and disability scale (PFPS): The PFPS is a survey that includes a series of 
key questions that relate to symptoms and control questions for plantar fasciitis 
(https://faoj.files.wordpress.com/2009/05/pain_scale_for_plantar_fasciiits.pdf). The PFPS also includes 
the VAS for pain and questions to measure the effect the pain has on their activities of daily living. 
This survey was designed to create a more descriptive, exclusive analysis for plantar fasciitis and 
has been shown to effectively discriminate pain that is unique to plantar fasciitis versus heel pain 
caused by other foot pathologies. 
 

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8.3 
SAFETY AND OTHER ASSESSMENTS 
Physical examination: A full physical examination, in addition to vital signs, including neurological 
examination of the face, general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, heart, 
lungs, abdomen, lymph nodes, and extremities will be conducted at Screening and pre-treatment at the 
Injection visit. At visits post-treatment, the physical examination may be abbreviated, as deemed 
medically appropriate at the discretion of the Investigator. Significant physical examination findings that 
are present prior to investigational product administration are to be included on the Medical History page. 
Significant physical examination findings which meet the definition of an adverse event will be recorded 
on the adverse event page post-treatment.  
Pregnancy Testing: All WOCBP will have a SPT at the Screening and at Week 16/Early Termination 
visits and UPT at Injection 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 trial center.  
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, Investigator 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 trial 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. 
Height, Weight, Vital Signs: Height will be collected only at the Screening visit. Weight and vital signs 
(i.e., body temperature, respiration rate, sitting radial pulse rate, and sitting systolic and diastolic blood 
pressures) will be obtained at the Screening, Injection Visit (pre- and post-treatment), Weeks 1, 2, 4, 8, 
and 16/Early Termination visits and at any visit where signs or symptoms of botulinum toxicity is 
reported.   
12-Lead Electrocardiograms (ECGs): At Screening, Week 2, and Week 16/Early Termination, a single 
standard supine 12-lead ECG will be obtained after a subject has rested quietly for at least 10 minutes. 
The ECG data will be submitted to a central reader for measurement. Instructions for the collection, 
transmission, and archiving of the ECG data is outlined in the ECG central reader manual. The analyzed 
ECG data will be reviewed and signed by the Investigator. 
X-rays: X-rays of the affected foot is collected at Screening or prior to Injection visit. This procedure is 
to be done at individual study site. If subject(s) have had X-ray done within six (6) months prior to the 

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Injection visit, this procedure is not required. Records of the X-ray is to be collected and kept with the 
subject’s study information.      
Biological specimen collection and laboratory evaluations: As outlined in the Clinical Laboratory 
Tests table below, non-fasting samples for hematology, chemistry, and urinalysis will be collected at 
Screening, Week 2, and at Week 16/Early Termination visits.
 
will be collected at Screening and Week 16/Early Termination visits. 
 
 Blood and urine will be collected using applicable safety 
precautions and will be processed according to the local clinical laboratory’s instructions.  
Clinical Laboratory Tests 
 
 
It is the Investigator’s responsibility to review the results of all laboratory tests as they become available. 
For each laboratory test result outside the reference range, the Investigator 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 visits, the Investigator must ascertain if this is an abnormal and clinically significant change 
pre-treatment for that individual subject. The Investigator may repeat the laboratory test or request 
additional tests to verify the results of the original laboratory test. The Investigator 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 8.4 for 
further information. 
 
 
 
 
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 
Pregnancy (WOCBP at 
Screening) 
Sodium 
Potassium 
Chloride 
CO2 
Creatinine 
Calcium 
Protein
Specific gravity 
pH 
Glucose 
Protein 
Blood 
Bilirubin 
Ketones 
 
 
 
 
 
 
 
 
 
 

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Injection Site Evaluation: The injection sites will be evaluated at Injection Visit (Day 0) pre- and post- 
treatment (to determine if there is an immediate reaction to the investigational product), follow-up visits 
(Weeks 1, 2, 4, 8 and 16 or Early Termination visit, if applicable. The assessment will be done as a global 
evaluation of the injection sites. 
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 
 
 
Foot and Ankle Examination: Examination for the foot includes ankle, toe, and subtalar range of 
motion, foot motor strength, location of pain, and examination of the heel fat pad and Tinel’s sign will be 
done at Screening, pre-treatment Injection, Weeks 1, 2, 4, 8, and 16/Early Termination visits. 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). 
Assessment of adverse events: Adverse Events (AEs) will be graded as mild, moderate, or severe as 
defined in Section 8.4.3 of this protocol. 
AEs will be evaluated at the Injection visit post-treatment, follow-up Weeks 1, 2, 4, 8, and 16 or Early 
Termination visits, if applicable. Section 8.4.5 outlines the procedures for recording and reporting AEs. 
Adverse events will be reported by the Sponsor in accordance with “21CRF part 312.32 and Guidance for 
Industry and Investigators: Safety Reporting Requirements.” The Investigator will report any serious 
adverse events (SAEs) to the IRB. 
 
 
 
 
 
 
 
 
 
 
 
 
8.4 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
8.4.1 DEFINITION OF ADVERSE EVENTS (AE) 
For this protocol, an adverse event (AE) is any untoward medical occurrence (e.g., sign, symptom, 
disease, syndrome, intercurrent illness, clinically significant abnormal laboratory finding, injury or 

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accident) that emerges or worsens following administration of investigational product and until the end of 
trial participation that may not necessarily have a causal relationship to the administration of the 
investigational product. 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 investigational product, whether or not considered related to the investigational product. 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 investigational product use will also be considered an adverse event. 
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 investigational product 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. 
8.4.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
A serious adverse event (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 Investigator, 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 investigational product 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 (1) of 
the outcomes listed above (i.e., is a significant or important medical event) 
8.4.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.4.3.1 SEVERITY OF EVENT 
The Investigator 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 

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 
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 
8.4.3.2 RELATIONSHIP TO STUDY INTERVENTION 
Relationship of an AE to investigational product will be assessed as follows: 
 
Definite: There is a clinically plausible time sequence between the onset of the AE and the 
administration of investigational product; when the event responds to withdrawal of 
investigational product and/or recurs with re-administration of investigational product 
 
Probable: There is a clinically plausible time sequence between the onset of the AE and the 
administration of investigational product; 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 investigational product and a cause cannot be ruled out 
 
Unrelated: There is not a temporal or causal relationship to investigational product 
administration 
8.4.3.3 EXPECTEDNESS  
The Medical Monitor and Sponsor will be responsible for determining whether an adverse event (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.   
8.4.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-
UP 
The occurrence of an adverse event (AE) or serious adverse event (SAE) may come to the attention of 
study personnel during study visits and interviews of a study participant presenting for medical care, or 
upon review by a study monitor. 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate case report form (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 participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any time 
during the study, it 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 Investigator or study 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 Investigator or study staff will inquire about the occurrence of 

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AE/SAEs since the last visit. Events will be followed for outcome information until resolution or 
stabilization. 
8.4.5 ADVERSE EVENT REPORTING  
The Investigator will assess subjects post-treatment and at each subsequent trial 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, an Investigator must report an SAE to Revance 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 Revance or the authorized representative as soon as the Investigator learns of the event. 
8.4.6 SERIOUS ADVERSE EVENT REPORTING 
An Investigator must report an SAE to Revance or the designated CRO’s 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 
Investigator’s assessment of causality. 
 If the event is fatal or life-threatening, telephone Revance or the authorized representative as 
soon as the Investigator learns of the event. 
 Obtain and maintain all pertinent medical records (discharge summary, autopsy report, etc.) 
and medical judgments of medical personnel who assisted in subject’s treatment and follow-
up. 
 Provide follow-up information to Revance or the authorized representative. 
All SAEs will be followed until satisfactory resolution or until the Investigator deems the event to be 
chronic or the participant is stable. Other supporting documentation of the event may be requested by the 
Data Coordinating Center (DCC)/study sponsor and should be provided as soon as possible. 
The study sponsor will be responsible for notifying the Food and Drug Administration (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 investigators in an Investigational New Drug (IND) safety report of 
potential serious risks, from clinical trials 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 Investigators will be notified of SAEs in accordance with 
applicable regulations and requirements (e.g., GCPs, ICH Guidelines, national regulations and local 
requirements). 
8.4.7 REPORTING EVENTS TO PARTICIPANTS  
Revance will disclose clinical trial data to individuals, to investigators at clinical sites, and publicly as 
aggregate summaries, in accordance to Regulatory and local legal requirements. 
8.4.8 FOLLOW-UP OF NON-SERIOUS ADVERSE EVENTS 
Non-serious AEs that are identified during the last scheduled trial visit (or early discontinuation, if 
applicable) must be recorded on the AE CRF as ongoing. 

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Any clinically significant abnormal test results, e.g., laboratory findings, at the Week 16/Early 
Termination visit should be followed to resolution or until determined by the Investigator 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 Investigator to arrange follow up evaluations at 
appropriate intervals to document the course of the abnormalities. 
8.4.9 FOLLOW-UP OF POST TRIAL 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 CRO and Revance according to the reporting 
procedures outlined in Section 8.4.6. This may include unresolved previously reported SAEs, or new 
SAEs. The Investigator should follow these SAEs until the events are resolved, or the subject is lost to 
follow-up. The Investigator should continue to report any significant follow-up information to the 
Medical Monitor, Revance, and the IRB/IEC up to the point the event has been resolved. Resolution 
means the subject has returned to the baseline state of health, or the Investigator does not expect any 
further improvement or worsening of the subject’s condition. 
Any new SAEs reported by the subject to the Investigator that occur after the last scheduled contact and 
are determined by the Investigator to be reasonably associated with the administration of investigational 
product should be reported to Revance and the IRB/IEC. 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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8.4.11 REPORTING OF PREGNANCY  
During the trial, all WOCBP should be instructed to contact the Investigator immediately (within 24 
hours) if they suspect they might be pregnant (e.g., missed or late menstrual cycle). The Investigator must 
immediately notify Revance or designated Contract Research Organization (CRO) of any female subject 
who becomes pregnant any time during study participation, record the information on the Pregnancy 
Notification Form and send the form to the CRO. The 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 trial. 
8.5 
UNANTICIPATED ADVERSE EVENTS 
8.5.1 DEFINITION OF UNANTICIPATED ADVERSE EVENTS 
 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving risks to 
participants 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 
participant 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 participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized 
Revance will comply with these criteria for reporting Unanticipated Adverse Events. 
8.5.2  UNANTICIPATED ADVERSE EVENT REPORTING  
The Investigator will report unanticipated Adverse Events to the reviewing Institutional Review Board 
(IRB) and the Sponsor. The unanticipated adverse event 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 adverse event;  
• 
A description of any changes to the protocol by the Sponsor or other corrective actions that have 
been taken or are proposed in response to the unanticipated adverse event. 
• 
The Sponsor will update the IB or provide Dear Doctor letter should these actions be deemed 
required.  
To satisfy the requirement for prompt reporting, unanticipated adverse events will be reported using the 
following timeline:   
 

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• 
Unanticipated adverse events that are fatal and life-threatening serious adverse events (SAEs) will 
be reported to the IRB and to the Sponsor within seven (7) days of the Investigator becoming 
aware of the event.  
• 
Any other unanticipated adverse events that are SAEs will be reported to the IRB and to the 
Sponsor within 15 days of the Investigator becoming aware of the problem.  
• 
All unanticipated adverse events that non-serious AEs are not required to be reported to the IRB 
or to the Sponsor.  
• 
All unanticipated serious adverse events should be reported to appropriate institutional officials 
(as required by an institution’s written reporting procedures), the supporting agency head (or 
designee), and the Office for Human Research Protections (OHRP) if applicable.  
8.5.3 REPORTING UNANTICIPATED ADVERSE EVENTS TO PARTICIPANTS  
Revance will disclose clinical trial data to individuals, to investigators at clinical sites, and publicly as 
aggregate summaries, in accordance to Regulatory and local legal requirements. 

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9 
STATISTICAL CONSIDERATIONS  
9.1 
STATISTICAL HYPOTHESIS 
Treatment with DaxibotulinumtoxinA for Injection of plantar fascia and plantar muscles combined with 
transient and selective partial paralysis of gastrocnemius/soleus complex (dysfunction) and a simple home 
program and inexpensive splinting will ameliorate signs and symptoms of plantar fasciitis; will improve 
function, and will optimize health related quality of life. 
9.2 
SAMPLE SIZE DETERMINATION 
With a total of 60 subjects (30 per group) and assuming a drop-out rate of no more than 20%,
 
 
 
 
 
 
 
 
 
 
 
9.3 
POPULATIONS FOR ANALYSES 
Approximately 60 subjects, 18-65 years of age, will be randomized in a 1:1 ratio to receive injections of 
either active (DaxibotulinumtoxinA for Injection) or placebo. 
 
 
 
9.4 
STATISTICAL ANALYSES 
9.4.1 GENERAL APPROACH 
All evaluable efficacy data will be included in the analysis following the intent-to-treat (ITT) principle. 
All subjects who received the study treatment (DaxibotulinumtoxinA for Injection or placebo) will 
comprise the modified-ITT population and will be grouped according to each subject’s randomization 
assignment. The primary analysis will focus on the reduction from baseline in the VAS for pain at eight 
(8) weeks with missing data imputed by the last available value prior to the visit with missing value, that 
is, the last-observation-carried-forward (LOCF) approach. Analysis of covariate (ANCOVA) model 
including treatment group as a factor and baseline pain score as a covariate will be used. 
Reductions from baseline VAS for pain for the foot over time up to eight (8) weeks will also be analyzed 
using a statistical method that handles repeated measures such as a generalized linear model (GLM) 
including treatment group, time (visit) and the treatment-visit interaction term as factors and the baseline 
VAS for pain as a covariates. For other secondary and exploratory efficacy outcome measures, 
appropriate statistical models (e.g., ANCOVA or GLM for continuous variables, and chi-squared/Fisher’s 

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exact test or logistic regression for dichotomy or categorical variables) adjusting for relevant covariates 
will be employed to evaluate the treatment effect. 
As a sensitivity analysis to check the impact of major protocol violations to study results, the primary and 
secondary efficacy outcome measures will also be analyzed on data from all subjects in per-protocol (PP) 
population, which consists of subjects in the modified-ITT population who do not have any major 
protocol violations. To check the robustness of results using the LOCF approach, different methods (such 
as observed data only or multiple imputation) may be employed to handle missing data when appropriate. 
As an exploratory analysis, proportion of subjects achieving certain status defined by some efficacy 
assessments (e.g., having a reduction in the VAS for pain by a certain clinical meaning cut-point) will 
also be compared between treatment groups. 
Safety data from all subjects who received study treatment will be summarized with subjects being 
grouped based on the treatment each subject actually received. 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
The primary endpoint is: 
 
Reduction in the visual analog scale (VAS) for pain for the foot at Week 8 
Analysis of the primary efficacy endpoint is fully defined in the statistical analysis plan.  
3 
 
  
 
 
 
 
 
 
 
 
 
  
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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6 
 
 
 
 
 
 
 
 
 
 
  
 
 
7 
 
  
 
 
 
9 
 
 
 
 
 
  
 

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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
10.1.1 INFORMED CONSENT PROCESS 
10.1.1.1 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 Investigator may discuss the trial 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 Investigator has both 
the ethical and legal responsibility to ensure that each subject being considered for inclusion in this trial 
has been given a full explanation of the procedures and expectations for study participation. 
The site-specific informed consent must be forwarded to Revance for approval prior to submission to an 
Institutional Review Board (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 International Council for Harmonisation (ICH) Good Clinical Practice (GCP) 
guideline, and applicable federal and local regulatory requirements. The consent form must also include a 
statement that Revance, 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 
Investigator (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 (Investigator 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 kept on file by the Investigator. All of the above activities must be 
completed before any study related procedures are conducted (including any screening study procedures). 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
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 Institutional Review 
Board (IRB)-approved and the participant will be asked to read and review the document. The 
Investigator will explain the research study to the participant and answer any questions that may arise. A 
verbal explanation will be provided in terms suited to the participant’s comprehension of the purposes, 
procedures, and potential risks of the study and of their rights as research participants. Participants will 
have the opportunity to carefully review the written consent form and ask questions prior to signing. The 

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participants should have the opportunity to discuss the study with their family or surrogates or think about 
it prior to agreeing to participate. The participant will sign the informed consent document prior to any 
procedures being done specifically for the study. Participants 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 participants 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 participant undergoes any study-specific procedures. The rights and welfare of the 
participants 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.] 
10.1.2 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 study participants, investigators, the Investigational New Drug 
(IND) sponsor and regulatory authorities. If the study is prematurely terminated or suspended, the 
Principal Investigator (PI) will promptly inform study participants, the Institutional Review Board (IRB), 
and sponsor and will provide the reason(s) for the termination or suspension. Study participants 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 participants 
 
Demonstration of efficacy that would warrant stopping  
 
Insufficient compliance to protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination that the primary endpoint has been met 
 
Determination of futility 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, and 
satisfy the sponsor, IRB and/or Food and Drug Administration (FDA). 
  
 
 
 
 
 
 
  
 
 
  
 

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10.1.6   SAFETY MONITORING/DATA MANAGEMENT COMMITTEE 
An independent Data Management 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. Following recruitment of all subjects, the DMC will evaluate all safety data available 
at timepoints specified in the Charter, and will make appropriate recommendations.  
10.1.7 MONITORING, COMPLIANCE, AND QUALITY 
All aspects of the trial will be monitored by Revance or authorized representatives of Revance according 
to Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs) for compliance with 
applicable government regulations, (i.e., Informed Consent Regulations and Institutional Review Board 
regulations). 
 
 
 
 
 
 
 
 
 
 
 

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10.1.9 DATA HANDLING AND RECORD KEEPING  
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
10.1.9.1.1 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 Investigator 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 Revance’s policy that the trial data be verifiable with the source data that necessitates access to all 
original recordings, laboratory reports, and other records for each subject. The Investigator must therefore 

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agree to allow access to subjects’ records, and source data must be made available for all trial 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 Investigator or Study Coordinator. Data queries 
will be sent to the trial center. Site personnel will be responsible for providing resolutions to the data 
queries and for correcting the CRFs, as appropriate. All unused Revance source documents and binders 
must be returned to Revance upon completion of the trial. 
The Investigator must keep written or electronic source documents for every subject participating in the 
clinical trial. The subject file that identifies the study in which the subject is participating must include the 
subject’s available demographic and medical information including:  
 
Date of birth 
 
Sex 
 
Race 
 
Ethnicity 
 
Medical history 
 
Comorbid conditions 
 
Concomitant therapies/medication 
 
Study visit dates 
 
Performed examinations, evaluations, and clinical findings 
 
Investigational product 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, trial number, and the date of 
the evaluation.  
The data recorded during the course of the trial will be documented in the CRF and/or the trial-specific 
forms. Before or at study termination, all data must be forwarded to Revance. 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 trial. The Investigator will 
ensure that the trial documents forwarded to Revance, 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 Investigator, or documented designee, stating the date of the 
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Investigator 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 Revance’s Quality Assurance group (or designee) may 
request access to all source documents, CRFs, and other trial documentation for on-site audit or 
inspection. The Investigator must guarantee direct access to these documents. CRFs will be kept by 
Revance 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 Revance after descriptive and statistical analyses and reports have been generated and are 
complete. 
10.1.9.1.2 FILE MANAGEMENT AT THE TRIAL CENTER 
It is the responsibility of the Investigator to ensure that the trial center file 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. 
10.1.9.2 RECORDS RETENTION AT THE TRIAL CENTER 
It is a sponsor requirement that all Investigators participating in clinical studies maintain detailed clinical 
data for one (1) of the following periods: 
 
Country-specific requirements, or 
 
A period of at least two (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 two (2) years after Revance notifies the Investigator that the data will not be 
submitted for review by any Regulatory Authority 
10.1.9.3 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 study staff to maintain contact with the study participants 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. 
10.1.10 
PROTOCOL DEVIATIONS  
This trial 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 Investigator (or a responsible, appropriately trained professional designated by the Investigator). In 
the event of a significant deviation from the protocol due to an emergency, accident, or mistake, the 
Investigator or designee must contact Revance at the earliest possible time by telephone. This will allow 

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an early joint decision regarding the subject’s continuation in the trial. This decision will be documented 
by the Investigator and the Sponsor. 
 
 
 
 
 
 
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
10.2 ADDITIONAL CONSIDERATIONS 
10.2.1 ETHICS AND RESPONSIBILITY 
This trial must be conducted in compliance with the protocol, the ICH Guidance for Industry E6 Good 
Clinical Practice: Consolidated Guidance and the applicable regulatory requirements. Investigators 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 Revance before 
investigational product will be shipped to the study site. 
 
 
 
 
 
 
 
 
 

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10.3 ABBREVIATIONS 
 
AE 
Adverse Event 
ANCOVA Analysis of Covariance 
AOFAS 
American Orthopaedic Foot and Ankle Score 
BoNTA 
Botulinum Toxin Type A 
BP 
Blood Pressure 
CFR 
Code of Federal Regulations 
cm 
Centimeter 
CRF 
Case Report Form 
CS 
Clinical Significant 
DMC 
Data Management Committee 
EC 
Ethics Committee 
ECG 
Electrocardiogram 
FADI 
Foot and Ankle Disability Index 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
HHS 
Health and Human Services 
HR 
Heart Rate 
IB 
Investigator’s Brochure 
ICH 
International Council for Harmonisation  
IM 
Intramuscular(ly) 
in 
Inch 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ITT 
Intention-To-Treat 
kDA 
Kilodalton 
MedDRA 
Medical Dictionary for Regulatory Activities 
mL 
Milliliter 
mm 
Millimeter 
msec 
Millisecond  
NCS 
Not Clinically Significant 
ng 
Nanogram 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PFPS 
Plantar Fasciitis Pain and Disability Scale 
PP 
Per Protocol 
PROMIS 
Patient Reported Outcome Measurement Information System 
QT 
Measurement of time between start of the q wave and the end of the t wave in the heart’s 
electrical conduction 
QTc 
Corrected QT interval; represents electrical systole 
Revance 
Revance Therapeutics, Inc. 
RT002 
DaxibotulinumtoxinA for Injection 
RTP004 
Revance absorption enhance peptide 
SAE 
Serious Adverse Event 
SC 
Subcutaneous 

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SoA 
Schedule of Assessments 
SOP 
Standard Operating Procedure 
SPT 
Serum Pregnancy Test 
TdP 
Torsade de Pointe 
U 
Units (botulinum toxin) 
UA 
Urinalysis 
UPT 
Urine Pregnancy Test 
US 
United States of America 
VAS 
Visual Analog Scale 
WFBMC 
Wake Forest Baptist Medical Center 
WOCBP 
Women of Child-Bearing Potential 
 
 
 

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