Five-Plus Year Follow-Up of SMART (Surgical Multicenter Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain) Trial
Conditions: Chronic Low Back Pain
Sponsor: Relievant Medsystems, Inc.

Relievant Medsystems 
 
INTRACEPT CIP 0011, Rev A 
Page 1 of 13 
CONFIDENTIAL AND PROPRIETARY 
April 5, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
Title: 
 
 
 
 
 
Five-Plus Year Follow-Up of SMART (Surgical Multi-
center Assessment of RF Ablation for the Treatment of 
Vertebrogenic Back Pain) Trial 
 
 
Protocol Number: 
 
Device: 
 
 
Regulatory Status: 
CIP 0011, Rev. A 
 
INTRACEPT® INTRAOSSEOUS NERVE ABLATION SYSTEM 
 
The device has FDA 510(k) clearance in the US and is CE 
marked in the EU for its intended purpose as defined in the 
Instructions for Use 
 
Sponsor: 
Relievant Medsystems 
8500 Normandale Lake Blvd., Suite 2150 
Minneapolis, MN 55437 
 
 
Date: 
April 5, 2019 
 
 
 
 
CONFIDENTIAL 
This document contains confidential information.  It is intended solely for the recipient and 
must not be disclosed to any other party.  The material may be used only for evaluating or 
conducting clinical investigations; any other proposed use requires Sponsor written consent. 
 
 
 

Relievant Medsystems 
 
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CONFIDENTIAL AND PROPRIETARY 
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Table of Contents 
1 
SYNOPSIS ............................................................................................................................................ 3 
2 
INTRODUCTION ................................................................................................................................ 4 
3 
STUDY DESIGN .................................................................................................................................. 5 
 
OVERVIEW ....................................................................................................................................... 5 
 
OBJECTIVE ....................................................................................................................................... 5 
 
SCOPE AND STUDY POPULATION ...................................................................................................... 5 
 
STUDY DURATION ............................................................................................................................ 5 
4 
PROTOCOL ......................................................................................................................................... 5 
5 
ENDPOINTS ......................................................................................................................................... 6 
 
PRIMARY EFFECTIVENESS ENDPOINT ............................................................................................... 6 
 
SECONDARY EFFECTIVENESS ENDPOINT .......................................................................................... 6 
6 
STATISTICAL ANALYSIS ................................................................................................................ 6 
 
STATISTICAL METHODS .................................................................................................................... 6 
7 
DESCRIPTION OF STUDY ASSESSMENTS .................................................................................. 7 
 
OSWESTRY DISABILITY INDEX ......................................................................................................... 7 
 
PAIN RATING SCALE FOR BACK PAIN ASSESSMENT ......................................................................... 7 
 
PATIENT SATISFACTION ................................................................................................................... 7 
 
NARCOTIC MEDICATIONS & INJECTIONS .......................................................................................... 7 
 
SURGICAL INTERVENTIONS .............................................................................................................. 8 
8 
STUDY RISK ANALYSIS ................................................................................................................... 8 
9 
IRB APPROVAL, INFORMED CONSENT, DATA COLLECTION, DATA HANDLING, AND 
RECORD KEEPING ................................................................................................................................... 8 
 
INSTITUTIONAL REVIEW BOARD (IRB) APPROVAL .......................................................................... 8 
 
INFORMED CONSENT ........................................................................................................................ 8 
 
CONFIDENTIALITY ............................................................................................................................ 8 
 
SOURCE DOCUMENTS ....................................................................................................................... 9 
 
REGULATORY COMPLIANCE ............................................................................................................. 9 
 
DATA QUALITY ASSURANCE ............................................................................................................ 9 
 
RECORD RETENTION ...................................................................................................................... 10 
10 STUDY FUNDING, SUBJECT STIPENDS, AND CONFLICTS OF INTEREST .......................10 
11 PUBLICATION POLICY ..................................................................................................................10 
12 REFERENCES ....................................................................................................................................11 
13. APPENDIX 1: INVESTIGATOR SIGNATURE PAGE ..................................................................13 
 

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CONFIDENTIAL AND PROPRIETARY 
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1 SYNOPSIS 
Protocol Title: 
Five-Plus Year Follow-up to SMART (Surgical Multi-center Assessment of RF 
Ablation for the Treatment of Vertebrogenic Back Pain) Trial  
Protocol 
Number: 
CIP 0011, Rev A 
Sponsor: 
Relievant Medsystems, Inc. 
Objectives 
The objective of this study is to evaluate long-term ongoing effectiveness of the 
Intracept® Intraosseous Nerve Ablation System for the treatment of chronic low back 
pain. 
Regulatory 
Status 
The Intracept® Intraosseous Nerve Ablation System is FDA 510(k) cleared and CE 
Marked for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the 
relief of chronic low back pain of at least 6 months’ duration that has not responded to 
at least 6 months of conservative care, and is also accompanied by either Type 1 or 
Type 2 Modic changes on magnetic resonance imaging (MRI). 
Study Design 
This is a prospective multi-center, noninterventional, observational post market data 
collection of the 5+ year effectiveness and satisfaction outcomes for the SMART trial 
population. 
Number of 
Subjects 
133 (subjects treated in original SMART protocol in the US) 
Number of Sites 
13 sites in the US 
Duration of 
Participation 
Subjects will be asked to complete one telephone study visit. 
It is estimated that this study will take approximately 6 months to re-contact the 
subjects and perform the study visit. 
Efficacy 
Assessments 
Pain, disability, satisfaction, and interventions, using the following measurements: 
• 
Oswestry Disability Index (ODI)-based questionnaire interview 
• 
Low back pain numeric rating (Scale 0 to 10) 
• 
Injections in last 12 months 
• 
Lower back interventions (since Intracept procedure) 
• 
Narcotics in last 30 days 
• 
Satisfaction survey 
 
 
 
 
 

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2 
INTRODUCTION 
Recent studies have demonstrated that vertebrogenic pain from degenerated or damaged 
vertebral endplates is an important source of chronic low back pain (CLBP).1-6  Vertebal 
endplate damage can lead to cellular communication between the disc nucleus and the 
bone marrow, triggering inflammation in the intraosseous space.4   The basivertebral 
nerve (BVN) within the vertebral disc has nociceptors that receive pain signals from the 
damaged and inflamed endplate and transmit these pain signals to the central nervous 
system.  Endplate damage and inflammation of the intraosseous space are visible as 
Modic changes on Magnetic Resonance Imaging (MRI).4 
 
The Intracept device is a minimally-invasive intervention using a transpedicular approach 
to deliver radiofrequency (RF) energy to ablate the BVN.  Once ablated, these nerves no 
longer transmit pain signals.  The Intracept® Intraosseous Nerve Ablation System is FDA 
510(k) cleared and CE Marked for the ablation of basivertebral nerves of the L3 through 
S1 vertebrae for the relief of chronic low back pain of at least 6 months’ duration that has 
not responded to at least 6 months of conservative care, and is also accompanied by either 
Type 1 or Type 2 Modic changes on magnetic resonance imaging (MRI). 
Following a successful pilot study7, a 2:1 randomized, double-blind, sham-controlled 
trial demonstrated the safety and efficacy of intraosseous RF ablation of the BVN to 
treat CLBP in patients with Modic type 1 or 2 changes of the vertebral endplates. The 
SMART trial was conducted between 2011 to 2014 and enrolled 225 subjects at 15 sites 
(N=202) in the United States and 3 sites (N=23) in Europe.8 The primary requirements 
for inclusion in the trial were CLBP with a duration greater than 6 months; CLBP non-
responsive to at least 6 months of non-surgical management; and Modic Type 1 or 2 
changes at the vertebral endplates of the levels targeted for treatment. 
The primary efficacy endpoint for the original study was the 3-month change in Oswestry 
Disability Index (ODI) compared between the study arms.  This comparison, as 
previously reported,8 found that at 3 months the per-protocol (PP) treatment group 
exhibited a 20.5 Least Squares Mean (LSM) improvement in ODI compared to a 15.2 
LSM improvement in the sham group (p = 0.019).  The PP treatment arm subjects 
exhibited a durable ODI mean improvement (23.4 points) at 24 months. 9  In terms of 
percent improvement in ODI from baseline, these results translate into mean percentage 
improvements of 46.2% at 12 months and 53.7% at 24 months.  Responder rates for ODI 
and low back pain visual analogue scale (VAS) were also maintained through two years, 
with patients showing clinically meaningful improvements in both: ODI ≥ 10-point 
improvement in 76.4 percent of patients and ODI ≥ 20-point improvement in 57.5 
percent; VAS ≥ 1.5 cm improvement in 70.2 percent of patients. Patients receiving the 
Intracept Procedure also decreased utilization of opioids and spinal injections as 
compared to utilization prior to treatment.  
 
The purpose of this study is to measure the 5+ year effectiveness outcomes in subjects 
treated with the Intracept Procedure in this original SMART study population.  

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3 
STUDY DESIGN 
 
Overview 
The SMART 5-Year study is a prospective multi-center, noninterventional, observational 
post market data collection of the 5+ year effectiveness and satisfaction outcomes for the 
SMART trial treatment arm population.  This trial will be conducted according to Good 
Clinical Practice (GCP) guidelines, including informed consent and Independent Review 
Board (IRB) approval and oversight.  
 
Objective 
To evaluate the 5+ year effectiveness outcomes of the Intracept Procedure for the relief of 
CLBP in the SMART trial treatment arm subjects. 
 
Scope and Study Population 
This study is a post-market, non-interventional, data collection of the 5+ year follow-up in 
the 133 treated subjects in the SMART trial in the U.S.  The study will be conducted at the 
same thirteen U.S. study sites where the procedures occurred.  U.S. subjects who were 
randomized to the treatment arm of the original SMART trial are eligible to participate in 
this 5+ year follow-up data collection.   
 
Study Duration 
Participants in the study will have a single study visit.  Participants will be consented and 
then evaluated via a single telephone study visit.  
4 
PROTOCOL 
This study entails contacting original SMART trial treatment arm subjects to seek 
participation in a data collection of current pain, functional status, and recent treatments.   
The study will be overseen at each participating study site by a primary investigator and 
clinical research coordinator (CRC). Telephone visits and data collection will conducted 
by an independent study-wide clinical research nurse (CRN).  
Five-Plus Year Follow-up Visit 
Study subjects who were randomized to the treatment arm and received treatment in the 
original SMART trial are eligible to participate in this 5+ year follow-up data collection. 
Each study site will make initial contact with the prior study patient and discuss the 
SMART 5+ year data collection and discern if the prior subject is interested in 
participating.  Informed consent will be obtained, and the same unique subject ID # used 
in the SMART trial will be assigned to the subject.   Study participant logs will include 
subject ID, date(s) of contact, and date of consent/decline to participate and will be 
maintained by the study site and independent CRN.   
Upon subject agreement to participate in the study, the CRC will forward subject contact 
information to the independent CRN who will then ensure informed consent and schedule 
the telephone study visit.  The independent CRN will perform the telephone study visit and 
will be responsible for collection of all data elements on source document worksheets 

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including administering a verbal ODI-based questionnaire, collecting a numeric rating of 
low back pain over the past 7 days, an assessment of narcotic medications for low back 
pain taken in the past 30 days, injections for low back pain in the last 12 months, and 
surgical interventions since the subject’s Intracept Procedure, and patient satisfaction with 
the Intracept Procedure.  The independent CRN will enter all data elements into the clinical 
database. 
5 
ENDPOINTS 
 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint for this study is the mean improvement in ODI from 
baseline to 5+ years. 
 
Secondary Effectiveness Endpoint 
Secondary effectiveness endpoints are: 
a) The mean reduction from baseline in patient reported pain.  
b) Responder rates for ODI - proportion of subjects who achieve ≥ 10-point 
reduction in ODI from baseline to 5+ years post-treatment. 
c) Responder rates for pain rating - proportion of subjects who achieve a ≥ 1.5-
point reduction in pain rating from baseline to 5+ years post-treatment. 
d) The proportion of patients with surgical interventions for low back pain of the 
same treatment region post the Intracept procedure. 
e) The proportion of patients currently utilizing opioids for low back pain of the 
same treatment region. 
f) The proportion of patients utilizing injections in the past 12 months  for low back 
pain of the same treatment region. 
g) Patient satisfaction with the Intracept Procedure. 
6 
STATISTICAL ANALYSIS 
 
Statistical Methods 
Demographic and baseline characteristics will be summarized using descriptive statistics.  
The mean change from baseline to five years in the ODI is the primary endpoint for this 
study. Statistical differences will be tested using Student’s t-test.  An analysis of 
covariance will also be performed using baseline characteristics and ODI measurments.  
Secondary endpoints will be summarized using descriptive statistics. 
• Mean reduction in pain rating baseline to 5+ years. 
• Responder rates for ODI will be determined by the proportion of subjects who 
achieve ≥ 10-point reduction in ODI from baseline to 5+ years post-treatment. 
• Responder rates for pain rating will be determined by the proportion of subjects 
who achieve a ≥ 1.5-point reduction in pain rating from baseline to 5+ years post-
treatment. 

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• Number and rate of surgical interventions post-procedure, as adjudicated by an 
independent reviewer. 
• The proportion of patients currently utilizing opioids for low back pain of the same 
treatment region. 
• The proportion of patients utilizing injections in the past 12 months for low back 
pain of the same treatment region. 
• Patient satisfaction with the Intracept Procedure at 5+ years. 
No imputations will be made for missing data. 
7 
DESCRIPTION OF STUDY ASSESSMENTS 
 
Oswestry Disability Index 
The Oswestry Disability Index (ODI) is a validated questionnaire of low back pain-
related disability.10  It assesses the impact of low back pain on activities of daily living 
and participation and includes 10 questions.  It is scored on a scale of 0 (no disability) to 
100 (complete disability), with categories of 0-20 (minimal disability), 21-40 (moderate 
disability), 41-60 (severe disability), 61-80 (crippling back pain), and 81-100 (bed-bound 
or exaggerating).  The minimally clinically important difference for this tool is 
considered to be 10 points.11.  For the purposes of this study, this will be administered 
over the phone. 
 
Pain Rating Scale for Back Pain Assessment 
The pain rating scale that will be used for this study is a 10-point numeric scale based on 
the Visual Analogue Scale (VAS) pain rating questionnaire12 used during the SMART 
study, 0 being no pain and 10 being worst imaginable pain.  Respondents are asked to 
indicate what integer on the scale corresponds to their perceived level of pain in their low 
back.  Subjects will be specifically instructed to report their level of low back pain as an 
average for the last seven days.  Studies have shown that a minimally clinically important 
difference in VAS is considered to be approximately 1.5 points.13   For the purposes of 
this study, this will be administered over the phone. 
 
Patient Satisfaction 
Satisfaction will be assessed with a short, non-validated questionnaire about degree of 
improvement, satisfaction with treatment, and willingness to repeat the treatment for the 
same outcome. 
 
Narcotic Medications & Injections 
Patient-reported low back narcotic usage will be captured at the 5+ year follow up visit.  
Drug type, prescribed dosage, and average daily dose for the last 30 days will be 
documented on the source document worksheet.  
Patient-reported injections within the last 12 months will be collected.  Date, type, and 
location for each injection will be recorded.  

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Surgical Interventions 
Surgical interventions performed since the Intracept Procedure will be captured.   Date, 
type and location of each intervention will be recorded.  
Interventions will be adjudicated by an independent reviewer. 
8 
STUDY RISK ANALYSIS 
This study is categorized as a non-significant risk study with minimal risk to subjects.  
The primary risk to study participants is a loss of confidentiality.  This risk will be 
mitigated through assignment of the unique Subject ID # and de-identification of data.  
Subject contact information will only be utilized by authorized independent CRNs (under 
patient consent) for purposes of conducting the study visit. 
There is no additional benefit to the study subjects for participating in the study.  There 
may be benefit to participants and future patients to learn about the long-term treatment 
effect of the Intracept Procedure.   
9 
IRB APPROVAL, INFORMED CONSENT, DATA COLLECTION, DATA HANDLING, 
AND RECORD KEEPING 
 
Institutional Review Board (IRB) Approval 
This study will be conducted under IRB review and approval of the protocol, the 
informed consent document/process, subject stipend, and study materials before the start 
of the study. 
 
Informed Consent 
Informed consent shall be obtained and documented before a subject is scheduled for the 
follow-up telephone visit.  It is the responsibility of the investigator/independent CRN to 
ensure that informed consent is obtained from the subject and documented before any 
study follow-up activity is undertaken. 
 
Confidentiality 
Subject medical information obtained for this study is confidential, and disclosure to third 
parties other than those authorized for the study and IRB/regulatory oversight is prohibited.  
Subjects will be only identified by the unique study number that the subject used during 
the SMART study. Data will be de-identified in a manner compliant with HIPAA 
regulations. 
Upon the subject’s agreement to participate, the independent CRN will schedule and 
conduct the telephone study visit.  Subject’s permission for the use of records for 
supplemental data and data verification purposes will be obtained prior to accessing 
subject’s medical records. 
Data generated by this study must be available for inspection upon request by 
representatives of the FDA, national and local health authorities, the Sponsor or its 
designee, and the IRB for the study site, if appropriate. 

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Source Documents 
Source data is all information, original records of clinical findings, observations, or other 
activities in a clinical trial necessary for the reconstruction and evaluation of the trial. 
Source data for this study is the patient-reported outcomes recorded on the source 
document worksheets, which will serve as the primary data collection instrument for the 
study.  A designated independent CRN will be responsible for conducting the 5+ year 
telephone visit, collecting the requested data at the visit, and for the timely completion 
and submission of data into the clinical database.    A clinical database will be used to 
store patient-reported questionnaire responses. Investigators will maintain all supporting 
medical records, and the independent CRN will maintain Informed Consent Forms and/or 
documentation of informed consent. 
 
Regulatory Compliance 
The Intracept System received FDA 510(k) clearance in 2016 for the Indications for Use 
being studied under this protocol.  This study will be conducted in compliance to 
applicable regulations contained in 21 CFR 11, 50, and 56, as well as the ICH/GCP 
Guidelines.  The investigator and all research staff participating in this study are expected 
to adhere to this protocol, applicable privacy laws, and any approval requirements 
imposed by the Institutional Review Board. The investigator has the further responsibility 
of adherence to the Investigator Agreement and to maintain the contents of the 
Regulatory Binder. 
 
Data Quality Assurance 
Steps to assure the accuracy and reliability of data include the selection of a qualified 
clinical investigator, site research personnel, and the study-wide independent CRN. 
Investigators and study personal will be trained on the protocol and study procedures  
prior to the study.  The Sponsor and/or its delegate will review data accuracy and 
completeness during and after the study, and any discrepancies will be resolved with the 
clinical investigator or designee as appropriate. 
The Sponsor has designed quality assurance procedures to ensure complete, accurate and 
timely data are collected and the study protocol requirements are followed. In addition to 
GCP and internal standard operating procedures, the SMART Trial 5+ year follow-up 
study will utilize the following procedures to further ensure quality: 
• 
Quality control of data submitted will be done by Sponsor, and any data problems 
will be addressed with the study site and or independent CRN.  
• 
All source worksheets and data files will be secured to ensure confidentiality. 
• 
The Sponsor will maintain regular contact with each study site and the independent 
CRN as needed to evaluate protocol compliance and/or to verify the study site 
facilities continue to be adequate. 
• 
The site will permit study-related audits and inspections by the IRB, the Sponsor and 
government regulatory bodies of all study-related documents (e.g., source documents, 
regulatory documents, data collection instruments, study data etc.). 
• 
Each Investigator is required to execute a Clinical Trial Agreement which delineates 
their responsibilities as an investigator. 

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Record Retention 
It is the Investigator’s responsibility to retain study essential documents for at least 2 
years after completion of the study. 
10 STUDY FUNDING, SUBJECT STIPENDS, AND CONFLICTS OF INTEREST 
Funding for study-related informed consent and the telephone follow-up visit is provided 
by Relievant Medsystems. Relievant Medsystems maintains policies to ensure 
compliance with the financial regulations for clinical studies. 
Subjects will be reimbursed reasonable costs for their time to perform the 5+ year 
telephone follow-up study visit.  Upon completion of the telephone study visit, the 
subject will be issued a stipend card.    
Patient payments will be made as directed in the Clinical Trial Agreement. The amount 
of stipend and conditions for payment to the subject will be outlined in the informed 
consent form and must be approved by the IRB.   
11 PUBLICATION POLICY  
The results of this trial will be reported regardless of whether the outcome is in favor of 
the trial interventions.  The Sponsor retains the right to review any submitted publications 
for accuracy prior to submission. Authorship of manuscripts will be based on 
International Journal Editors’ guidelines for authorship. 
 
 

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12 REFERENCES 
1. Lotz JC, Fields AJ, Liebenberg EC. The role of the vertebral end plate in low 
back pain. Global Spine J. 2013;3(3):153-64. doi:10.1055/s-0033-1347298. 
 
2. Dudli S, Fields AJ, Samartzis D, Karppinin J, Lotz JC. Pathobiology of Modic 
changes. Eur Spine J. 2016;25(11):3723-34. doi:10.1007/s00586-016-4459-7. 
 
3. Munir S, Freidin MB, Rade M, Määttä J, Livshits G, Williams FMK. Endplate 
defect is heritable, associated with low back pain and triggers intervertebral disc 
degeneration: a longitudinal study from twinsUK. Spine. 2018;43(21):1496-1501. 
doi:10.1097/BRS.0000000000002721. 
 
4. Dudli S, Sing DC, Hu SS, Berven SH, Burch S, Deviren V, et al. ISSLS PRIZE 
IN BASIC SCIENCE 2017: Intervertebral disc/bone marrow cross-talk with 
Modic changes. Eur Spine J. 2017;26(5):1362-73. doi:10.1007/s00586-017-4955-
4. 
 
5. Fras C, Kravetz P, Mody DR, Heggeness MH. Substance P-containing nerves 
within the human vertebral body. an immunohistochemical study of the 
basivertebral nerve. Spine J. 2003;3(1):63-7. 
 
6. Bailey JF, Liebenberg E, Degmetich S, Lotz JC. Innervation patterns of PGP 9.5-
positive nerve fibers within the human lumbar vertebra. J Anat. 2011;218(3):263-
70. 10.1111/j.1469-7580.2010.01332.x. 
 
7. Becker S, Hadjipavlou A, Heggeness MH. Ablation of the basivertebral nerve for 
treatment of back pain: a clinical study. Spine J. 2017;17(2):218-23. DOI: 
10.1016/j.spinee.2016.08.032. 
 
8. Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, et al. Intraosseous 
basivertebral nerve ablation for the treatment of chronic low back pain: a 
prospective randomized double-blind sham-controlled multi-center study. Eur 
Spine J. 2018;27(5):1146-56. DOI: 10.1007/s00586-018-5496-1. 
 
9. Fischgrund JS, Rhyne A, Franke J, Sasso R, Kitchel S, Bae H, et al. Intraosseous 
basivertebral nerve ablation for the treatment of chronic low back pain: two-year 
results from a prospective randomized double-blind sham-controlled multi-center 
Study. Int J Spine Surg. In Press. 
 
10. Roland M, Fairbank J. The Roland Morris disability questionnaire and the 
Oswestry disability questionnaire. Spine. 2000;25(24):3115-24. 
 
11. Hagg O, Fritzell P, Nordwall A (2003) The clinical importance of changes in 
outcome scores after treatment for chronic low back pain. Eur Spine J 12(1):12–
20. https ://doi.org/10.1007/ s0058 6-002-0464-0 
 

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12. Price DD, McGrath PA, Rafii A, Buckingham B. The validation of visual 
analogue scales as ratio scale measures for chronic and experimental pain. Pain. 
1983;17(1):45-56. 
 
13. Ostelo RW, de Vet HC (2005) Clinically important outcomes in low back pain. 
Best Pract Res Clin Rheumatol 19(4):593–607. https 
://doi.org/10.1016/j.berh.2005.03.003. 
 
 
 

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13. APPENDIX 1: INVESTIGATOR SIGNATURE PAGE 
 
Title: 
 
 
 
Five-Plus Year Follow-Up of SMART (Surgical Multi-
center Assessment of RF Ablation for the Treatment of 
Vertebrogenic Back Pain) Trial 
 
 
Protocol Number: 
 
 
CIP 0011, Rev. A 
 
 
Date: 
April 5, 2019 
 
I have received and read the protocol listed above.  I agree to undertake the protocol as 
defined therein and in accordance with the relevant parts of the 21 CRF 50 Protection of 
Human Subjects, ICH Guidelines for GCP, ISO 14155, the Declaration of Helsinki, and 
any other pertinent individual country laws/regulations.  I am aware that my adherence to 
the above protocol is mandatory and that any changes in the protocol or consent form must 
first be approved by the Sponsor and the Institutional Review Board, except those changes 
necessary to eliminate apparent immediate hazards to patients, or purely administrative 
changes, which must first be approved by the Sponsor.  Failure to adhere to these 
stipulations may constitute a breach of United States Federal Regulations and may result 
in my termination of the study. 
 
 
Principal Investigator (Print Name) 
 
 
Principal Investigator (Signature) 
 
 
Date: