A Phase IIIB Randomized, Open Label, Two Arms and Parallel Group Clinical Trial to Assess the Efficacy and Safety of FIRTECH (Infrared Therapy Patch), for Treating Patients Suffering From Mild to Moderate Acute Low Back Pain
Phase: PHASE3
Conditions: Low Back Pain
Sponsor: Sanofi

A phase IIIB randomized, open label, two arms and parallel group clinical 
trial to assess the efficacy and safety of FIRTECH (Infrared Therapy 
Patch), for treating patients suffering from mild to moderate acute low 
back pain 
Study Name:  IRPATCH 
Version 4 / 22 July 2022 
Regulatory Sponsor: 
SAR&D Sanofi-Aventis Recherche & Développement 
1 Avenue Pierre Brossolette 
91380 Chilly-Mazarin 
France 
Study Product: 
FIRTECH Infrared Therapy Patch 
Protocol Identifiers: 
Study Number: LPS16453 
WHO Universal Trial Number:  U1111-1255-4648 
CONFIDENTIAL 
This document is confidential and the property of Sanofi-Aventis Recherche & Développement. 
NCT05137041

Sanofi-Aventis Recherche & Développement 
 
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Statement of Compliance 
This document is a protocol for a human research study.  This study will be conducted according 
to US and International standards of Good Clinical Practice, applicable government regulations 
and Institutional research policies and procedures.   
All individuals responsible for the design and conduct of this study have completed Human 
Subjects Protection Training and are qualified to be conducting this research prior to the 
enrollment of any subjects.   
As Principal Investigator, I agree to conduct this clinical study in accordance with the design 
and specific provisions of this protocol.  Modifications to the study are acceptable only with an 
approved protocol amendment.  I agree to obtain approval from the IRB and/or regulatory 
bodies of competent jurisdiction, for the protocol and informed consent before initiating the 
study, to obtain consent from subjects prior to their enrollment in the study, to collect and record 
data as required by this protocol and case report forms, to prepare adverse event and study 
reports as required by this protocol and to maintain study documentation for the period of time 
required. 
 
 
________________________________________________ 
_________________ 
[Print Name/Title of Principal Investigator]  
 
 
Date 
 
 
As a Sub-Investigator, I agree to conduct this clinical study in accordance with the design and 
specific provisions of this protocol.  Modifications to the study are acceptable only with an 
approved protocol amendment.  I agree to obtain approval from the IRB and/or regulatory 
bodies of competent jurisdiction, for the protocol and informed consent before initiating the 
study, to obtain consent from subjects prior to their enrollment in the study, to collect and record 
data as required by this protocol and case report forms, to prepare adverse event and study 
reports as required by this protocol and to maintain study documentation for the period of time 
required. 
 
________________________________________________ 
_________________ 
[Print Name/Title of Sub- Investigator] 
 
 
 
 
Date 
[Print Location if multi-site protocol] 
 
________________________________________________ 
_________________ 
[Print Name/Title of Sub- Investigator] 
 
 
 
 
Date 
[Print Location if multi-site protocol] 
 
 
 

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Version History 
Version # 
Approval Date 
Significant Changes from Previous Version 
Version 1 
24 
September 
2020 
Original Protocol Version 
Version 2 
12 April 2021 
Amendment 1:  
 to reflect recent optimized shape of the patch to 
improve hold 
 to consider COVID  pandemic context 
 to address German Ethics Committee requests 
Version 3 
29 March 2022 
Amendment 2: 
Admin change on Protocol Synopsis to Study centers 
Version 4 
22 Jul 2022 
Amendment 3: 
Revision of Inclusion and exclusion criteria  
 
 
 
 
 
 
 
 
 

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Table of Contents 
Statement of Compliance ........................................................................................................... 2 
Version History .......................................................................................................................... 3 
Study Synopsis ........................................................................................................................... 7 
Abbreviations ............................................................................................................................. 9 
1 
Study Contact Information................................................................................................ 10 
1.1 
Sponsor Contact Information .................................................................................... 10 
1.2 
Principal Investigator Contact Information ............................................................... 10 
1.3 
Sub-Investigators Contact Information ..................................................................... 10 
1.4 
Key Study Personnel ................................................................................................. 10 
1.4.1 
Clinical Study Monitor ....................................................................................... 10 
1.4.2 
Medical Monitor................................................................................................. 10 
1.4.3 
Statistician .......................................................................................................... 10 
2 
Introduction / Background and Rationale ......................................................................... 10 
3 
Device Description ........................................................................................................... 12 
4 
Device Accountability ...................................................................................................... 13 
4.1 
Device Receipt .......................................................................................................... 13 
4.2 
Device Storage .......................................................................................................... 13 
4.3 
Device Dispensing ..................................................................................................... 14 
4.4 
Device Disposition .................................................................................................... 14 
4.5 
Return or Destruction of Unused Devices ................................................................. 14 
5 
Study Objectives ............................................................................................................... 15 
5.1 
Primary Objective ...................................................................................................... 15 
5.2 
Secondary Objectives ................................................................................................ 15 
5.3 
Exploratory Objectives .............................................................................................. 15 
6 
Study Design ..................................................................................................................... 15 
6.1 
Overview of Study Design ........................................................................................ 15 
6.2 
Anticipated Duration of the Clinical Investigation ................................................... 16 
6.3 
Evaluation Criteria / Efficacy and Safety .................................................................. 16 
6.3.1 
Primary Efficacy Clinical Endpoint ................................................................... 16 
6.3.2 
Secondary Efficacy Clinical Endpoint(s) ........................................................... 16 
6.3.3 
Exploratory Endpoints ....................................................................................... 17 
6.3.4 
Safety Endpoints ................................................................................................ 17 
6.4 
Study Population ....................................................................................................... 18 
6.4.1 
Sample Size ........................................................................................................ 18 
6.4.2 
Subject Recruitment ........................................................................................... 18 
6.4.3 
Subject Screening ............................................................................................... 18 
6.4.4 
Prior and Concomitant Therapy or Medications ................................................ 19 

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6.4.5 
Inclusion Criteria ................................................................................................ 19 
6.4.6 
Exclusion Criteria............................................................................................... 20 
6.4.7 
Exit / Discontinuation Criteria ........................................................................... 21 
6.5 
Premature Termination or Suspension of the Study .................................................. 21 
7 
Study Procedures .............................................................................................................. 21 
7.1 
Informed Consent ...................................................................................................... 21 
7.2 
Vulnerable Populations ............................................................................................. 22 
7.3 
Randomization Scheme ............................................................................................. 22 
7.4 
Blinding / Unblinding ................................................................................................ 22 
7.5 
Laboratory Testing Procedures ................................................................................. 22 
7.6 
Clinical Procedures .................................................................................................... 22 
7.6.1 
Day 1, Visit 1 ..................................................................................................... 22 
7.6.2 
Day 1 to Day 5, At Home................................................................................... 24 
7.6.3 
Day 5, Visit 2 Patch Removal / End of Treatment ............................................. 24 
7.6.4 
Day 6, Phone Contact:  End of Study ................................................................ 25 
7.6.5 
Unscheduled Visit .............................................................................................. 25 
7.7 
Follow-Up Procedures and Therapy Transitions ....................................................... 25 
7.8 
Study Timetable / Schedule of Events ...................................................................... 25 
7.9 
Study Protocol Compliance / Treatment Adherence ................................................. 27 
7.10 Deviations from the Clinical Protocol ....................................................................... 27 
7.11 Subject Withdrawal ................................................................................................... 27 
7.11.1 
Subject Withdrawal ............................................................................................ 27 
7.11.2 
Data Collection and Follow-Up for Withdrawn Subjects .................................. 27 
7.12 Subject Compensation ............................................................................................... 27 
8 
Data Collection and Analysis ........................................................................................... 27 
8.1 
Subject Descriptions .................................................................................................. 28 
8.2 
Subject Population(s) for Analysis ............................................................................ 28 
8.3 
Statistical Methods .................................................................................................... 28 
8.3.1 
Efficacy Analyses............................................................................................... 28 
8.3.2 
Safety Analyses .................................................................................................. 31 
9 
Safety and Adverse Events ............................................................................................... 32 
9.1 
Definitions ................................................................................................................. 32 
9.2 
Safety Monitoring Plan ............................................................................................. 34 
9.2.1 
Anticipated Risks / Risk Mitigation ................................................................... 34 
9.2.2 
Medical Monitoring for Participant Safety ........................................................ 34 
9.3 
Anticipated Adverse Events ...................................................................................... 35 
9.4 
Adverse Event Reporting .......................................................................................... 35 
9.4.1 
Adverse Events................................................................................................... 35 
9.4.2 
Serious Adverse Events...................................................................................... 36 
9.4.3 
Unanticipated Adverse Device Effects (UADE) ................................................ 37 

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10 
Data Handling and Record Keeping ............................................................................. 37 
10.1 Confidentiality ........................................................................................................... 37 
10.2 Source Documents ..................................................................................................... 37 
10.3 Case Report Forms and e-diaries ............................................................................... 38 
10.4 Clinical Reports ......................................................................................................... 38 
10.5 Records Retention ..................................................................................................... 38 
11 
Study Monitoring, Auditing, and Inspecting ................................................................ 38 
11.1 Study Monitoring Plan .............................................................................................. 38 
11.2 Auditing and Inspection ............................................................................................ 39 
12 
Protocol Amendments After Study Initiation ............................................................... 39 
13 
Ethical Considerations .................................................................................................. 39 
14 
Study Finances .............................................................................................................. 39 
14.1 Funding Source .......................................................................................................... 39 
14.2 Conflicts of Interest ................................................................................................... 40 
15 
Publication Plan ............................................................................................................ 40 
16 
References ..................................................................................................................... 40 
17 
Appendices and Attachments ........................................................................................ 40 
17.1 Roland-Morris Low Back Pain and Disability Questionnaire ................................... 40 
17.2 Mobility Test ............................................................................................................. 42 
17.3 Instructions for Patch Use ......................................................................................... 43 

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Study Synopsis 
Title 
A phase IIIB randomized, open label, two arms and parallel group clinical trial to 
assess the efficacy and safety of FIRTECH (Infrared Therapy Patch), for treating 
patients suffering from mild to moderate acute low back pain. 
Short Title 
Efficacy and Safety of FIRTECH in Patients with Mild to Moderate Acute Low 
Back Pain 
Protocol Numbers 
LPS16453 
Study Sponsor 
SAR&D Sanofi-Aventis Recherche & Développement 
Principal Investigator 
TBD  
Study Design 
This is an open label, randomized, patch arm vs. and no-patch control arm, clinical 
trial. 
Study Duration 
12 months 
Study Center(s) 
Approximately 10 centers in Germany and Italy  
Objectives 
Primary:  To assess the efficacy of the ITP FIRTECH for treating subjects 
suffering from mild to moderate acute low back pain 
Secondary:   
 To assess the efficacy of ITP FIRTECH on the subject disability. 
 To assess the efficacy of ITP FIRTECH on the degree of subject mobility. 
 To assess the safety of ITP FIRTECH 
Number of Subjects 
200 enrolled subjects:  180 evaluable subjects (90 in each arm). 
Main Inclusion / 
Exclusion Criteria 
Inclusion: 
1. 
Male or female subjects who are ≥18 years and < 65 years. 
2. 
Subjects suffering from mild to moderate acute low back pain. 
 Low back pain (lumbar back pain) is defined as pain in the back from the 
level of the lowest rib down to the gluteal fold.  
 Acute episode is defined as acute pain with less than 1 month duration. 
 With intensity ≤ 6 on 0-10 Numerical Rating Scale (NRS) 
Exclusion: 
1. 
Subjects suffering from any neurological pathology which could be 
responsible for the pain. 
2. 
Subjects suffering from leg pain irradiation. 
3. 
Subjects suffering from chronic lumbar pain of any etiology. 
4. 
Subjects with chronic arthrosis and neurological symptoms   
5. 
Subjects experiencing recent significant trauma (i.e., injury related to a fall 
from a height or motor vehicle crash, or from a minor fall or heavy lifting in 
a subject with osteoporosis or possible osteoporosis), 
6. 
Subjects with major or progressive motor or sensory deficit, new-onset 
bowel or bladder incontinence or urinary retention, loss of anal sphincter 
tone, saddle anesthesia, history of cancer metastatic to bone, and suspected 
spinal infection. 
7. 
Subjects clinically diagnosed with anxiety and/or depression 
8. 
Subjects using any medication for their pain within the last 48 hours within 
enrollment into the study  
9.    Subjects taking any systemic medication for their pain within the last 24 hours 
(48 hours for diclofenac or corticosteroids).   

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10. Subjects currently using recreational or illicit drugs or with a recent history 
of drug or alcohol abuse or dependence. 
11. Subjects with any other medical condition that would interfere with efficacy 
and safety assessments based on investigator’s judgment.  
12. Subjects 
having 
received 
non 
pharmaceutical 
LBP 
treatment 
(physiotherapy, heat treatment or massage) within 12 hours prior enrollment  
13. Subjects having received spinal injection back pain treatment within 6 
months prior enrollment 
14. Subjects having received surgery due to back pain or rehabilitation due to 
back pain in the last 12 months  
15. Subjects with a known sensitivity to paracetamol  
16. Known cutaneous hypersensitivity to plaster  
17. Subjects participating in another clinical study within the past 30 days 
18. Subjects who are pregnant or breastfeeding.  Contraception is mandatory 
19. Subjects having damaged, non-intact, or scarred skin in or near the point of 
patch application. 
20 
Subjects having a known skin sensitivity. 
21. Subjects having impaired blood circulation. 
Study Device 
FIRTECH Infrared Therapy Patch 
Duration of Device 
Exposure 
5 days 
Reference Therapy 
None 
Endpoints 
Primary:  A Numerical Rating Scale (NRS) responder at Day 5 at the on-site 
evaluation (defined as ≥ 30% decrease from baseline of the instantaneous pain 
and no rescue medication). 
Secondary:   
 Normalized Sum of Pain Intensity Difference (PID, which equals the NRS 
change from baseline) over 5 days (SPID0- 5).  
 Roland-Morris Disability Questionnaire (RMDQ) score improvement (%) 
from baseline to Day 5. 
 Mobility evaluation: change from baseline to Day 5 
 Time to reach acceptable pain 
Other secondary endpoints  
 Time to reach no pain (NRS = 0) 
 Time course of PID over time from baseline to Day 5 on-site evaluation 
 Time course of Pain relief over time from baseline to Day 5 on-site 
evaluation 
 Normalized Sum of Pain relief over 5 days (TOTPAR0- 5) 
 Safety. 
Exploratory endpoints 
 Frequency of use of rescue medication  
 Description of “worst pain” evaluation  
 Description of “least pain” evaluation 
 Description of “average pain” evaluation 
Statistical Methods 
For efficacy evaluations, Fisher’s exact tests will be performed to compare 
proportions (like proportion of responders for the primary endpoint) 
questionnaires and time-course data will be summarized by visit, time-to-event 

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data will be displayed and analyzed using the Kaplan–Meier method and tested 
using the log rank test. Efficacy data will be summarized and analyzed under the 
Intent-to-Treat paradigm.  Safety, tolerability and compliance will be 
summarized under the “As Treated” paradigm: frequencies and proportions will 
be summarized as per actual arm (patch/no patch) 
 
 
Abbreviations 
AE 
Adverse Event 
CRF 
Case Report Form 
DSE 
Device Specific Event 
GCP 
Good Clinical Practice 
GDPR 
General Data Protection Regulation 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
LBP 
Low Back Pain 
NRS 
Numerical Rating Scale 
PHI 
Protected Health Information 
PID 
Pain Intensity Difference 
RMDQ 
Roland-Morris Disability Questionnaire 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
TEAE 
Treatment Emergent Adverse Event 
TOTPAR 
Normalized Sum of Pain relief over 5 days 
UADE 
Unanticipated Adverse Device Effect  
VRS 
Verbal Rating Scale 
 
 
 

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1 
Study Contact Information 
1.1 
Sponsor Contact Information 
SAR&D Sanofi-Aventis Recherche & Développement 
1 Avenue Pierre Brossolette 
91380 Chilly-Mazarin 
France 
1.2 
Principal Investigator Contact Information  
TBD 
[Investigator Address] 
[Investigator Office Phone] 
[Investigator Mobile Phone] 
[Investigator E-mail] 
1.3 
Sub-Investigators Contact Information  
TBD 
[Investigator Address] 
[Investigator Office Phone] 
[Investigator Mobile Phone] 
[Investigator E-mail] 
1.4 
Key Study Personnel 
1.4.1 Clinical Study Monitor 
ICON Clinical Research 
1.4.2 Medical Monitor 
Sanofi- Aventis Recherche & Développement 
1.4.3 Statistician 
ICON Clinical Research 
2 
Introduction / Background and Rationale 
Low back pain (lumbar back pain) is defined as pain in the back from the level of the lowest 
rib down to the gluteal fold.  An acute pain episode is defined, as acute pain with less than 1 
month duration, however, there is non consistency across international guidelines to define 
acute versus chronic pain [1]. 

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Back pain affects between 60% and 80% of all people at some time in their life. Fifteen to forty-
five percent of adults suffer LBP, and 1/20 (5%) people present to a healthcare professional 
with a new episode.  Low back pain is most common between the ages of 35 to 55 years.  About 
30% of European workers reported that their work caused LBP.  Prevalence varies across 
countries, ranging from 13% to 44%.  In 50% to 80% of people with acute LBP, symptoms 
recur within 1 year, indicating a high recurrence rate.  Thirty-three percent of people still endure 
moderate-intensity pain and 15% experience severe pain 1 year after the initial episode.  Fifty 
percent of episodes nearly completely resolve within two weeks, and 80% by six weeks[2]. 
Patients with peripheral pain may achieve pain relief with currently recommended first-line oral 
treatments, which are also associated with systemic adverse events.  Topical treatments are 
currently considered second-line options, but their safety profiles are better than oral treatments.  
Infrared Therapy Patches (ITP) are Class I Medical Devices and can relieve painful symptoms 
without the use of drugs.  The effects duration varies according to each person’s state of health. 
The objective of the LPS16453 study is to determine the efficacy and safety of the ITP 
FIRTECH compared with no-patch control arm for treating acute mild to moderate low back 
pain. 
The study is designed as open label with a no-patch control arm.  The following items had been 
taken into account in this decision: 
• 
It is necessary to provide controlled data in support of the therapeutic effect.  These types 
of body pain are self-limiting and many patients will improve even without any treatment.  
Just observing treated patients and recording their improvement (post- versus pre-
treatment) will not allow description of the level of effect coming from the patch.  
• 
There is no real sham (placebo).  The double blind approach is impossible to reach.  In 
fact, the active compound is part of the tissue structure: 
o The purpose of the clinical study is to prove the efficacy of re- emitted IR energy for 
pain relief.  This is not specifically limited to the IR re-emitted from particles such 
as titanium dioxide.  Other components of the patch such as the fabrics also re-emit 
IR. 
o The efficacy of the patch maybe therefore not only be associated with the used 
ceramic particles, but with the entire patch respectively re-emitting IR.  
o In theory, the placebo of the IR emitting patch should be designed as a non-emitting 
patch (i.e., all materials of construction have zero emissivity).  All materials emit and 
re-emit IR (to various degrees).  Therefore, a completely non-emitting placebo device 
cannot be produced/manufactured. 
o The similar tissue has effect of reflection of the emitted infrared radiation; this patch 
would not be a placebo in the true sense of the definition. 

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•
All study participants have access to rescue medication.  Treatment is available and even
a delay in the treatment will not automatically result in a worsening of the medical
condition.
The study will be performed according to all local regulations. 
3 
Device Description 
The device consists of a patch 
 applied to the skin surface.  The FIRTECH 
patch consists of two layers, a TNT (Polypropylene) support coated with an adhesive 
containing Titanium Dioxide, printed in the upper part.  It contains a film of transparent 
polyethylene terephthalate (PET) that serves as a protective support for the adhesive layer.  
This protective film is pre-cut to facilitate easier application of the patch to the skin. Titanium 
dioxide belongs to the category of molecule with a high emittance, the intrinsic ability to 
“receive” and “re-emit” specific wavelengths.  Specifically, the emittance of titanium dioxide 
is located in a range of infrared (IR) frequencies that notoriously have an interesting 
therapeutic aspect. 
 
 
 
 the composition listed in Table 1. 
Table 1.  FIRTECH Infrared Therapy Patch Composition 
Support 
Non woven fabric – white (Polypropylene) [CAS #9003-07-0] 
Adhesive 
Polyacrylate [CAS #25133-97-5] 
Protective support 
Polyethylene terephthalate  [CAS #25038-59-9] 
Chemical element 
Titanium Dioxide [CAS #13463-67-7] and Synthetic wax 
(poly(alpha-olefins, alkenes, C>10 alpha-, polymerised)) 
The medical device under review contains no analgesics, no tissues or blood products or cells, 
or their derivatives, of human or animal origin.  
 
 

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All investigational devices will have the following label statement:  CAUTION – For 
Investigational Use Only.   
4 
Device Accountability 
4.1 
Device Receipt 
Devices will be shipped directly to the investigator from the Sponsor.  Upon receipt by the 
Investigator, devices will be inventoried and stored as per Section 4.2 below.  For inventory 
purposes, each device will be assigned an inventory number which will be recorded on an 
inventory log. 
4.2 
Device Storage 
Devices will be stored in a restricted access location with access by the Investigator or 
designee only.  Devices will be stored under ambient conditions.  There are no special 
handling requirements for this device. 
 
 

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4.3 
Device Dispensing 
Devices will be dispensed by the Investigator, or designee, as needed for each Subject.  For 
device accountability, device inventory numbers will be recorded on the Subject’s case 
report form, and the Subject’s ID number will be recorded on the inventory log.  The 
inventory log will be reconciled with Subject records during the monitoring visits and this 
reconciliation will be noted on the device inventory form, and signed and dated by the 
study team designee. 
4.4 
Device Disposition 
At the end of the study period, the Subject will return to the investigational site to have the 
patch removed.  If the patch is removed or if it peels off prior to its scheduled removal, 
Subjects are instructed to apply a new patch at home.  All the used and unused patches 
have to be returned to the investigational site at Visit 2   
4.5 
Return or Destruction of Unused Devices 
Returned and/or unused devices are to be destroyed or returned to the Sponsor at the 
Sponsor’s discretion.  All devices must be accounted for in the inventory log.  If devices 
are to be returned to the Sponsor, the Sponsor will provide shipping instructions at that 
time. 
 
 

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5 
Study Objectives 
5.1 
Primary Objective 
The Primary objective of the study is to assess the efficacy of the ITP FIRTECH for 
treating subjects suffering from mild to moderate acute low back pain. 
5.2 
Secondary Objectives 
The Secondary objectives of this study are listed below: 

To assess the efficacy of ITP FIRTECH on the subject disability.

To assess the efficacy of ITP FIRTECH on the degree of subject mobility.

To assess the safety of ITP FIRTECH
5.3 
Exploratory Objectives 
Exploratory objectives for this study include: 

To assess the frequency and use of rescue  medication

To assess the subject evaluations of least, average , and worst pain
6 
Study Design 
6.1 
Overview of Study Design 
This is an, open label, randomized, proof-of-concept clinical trial; comparing the ITP 
FIRTECH with a no-patch control arm.  The study will be performed in Medical Centers 
and an online e-diary will be used. 
A total of 2 site visits and 1 phone contact are planned during a maximum of 6 days of 
study duration, as shown in Figure 2. 

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Figure 2.  Study Schema 
6.2 
Anticipated Duration of the Clinical Investigation 
The estimated study duration from first enrollment to last Subject visit is approximately 2 
months.  This study duration will require approximately 5 subjects to be enrolled per week 
at each site. 
6.3 
Evaluation Criteria / Efficacy and Safety 
6.3.1 Primary Efficacy Clinical Endpoint 
A Numerical Rating Scale[3] (NRS) responder at Day 5 at the on-site evaluation 
(defined as ≥ 30% decrease from baseline of the instantaneous pain[4] and no rescue 
medication) 
6.3.2 Secondary Efficacy Clinical Endpoint(s) 
Key secondary endpoints  
 Normalized Sum of Pain Intensity Difference (PID, which equals the 
instantaneous NRS change from baseline) over 5 days (SPID0- 5).  The Sum of 
Pain Intensity Difference (SPID) is to be calculated by multiplying the PID score 
at each post dose time point by the duration (in hours) since the preceding time 
point.  The Normalized Sum of Pain Intensity Difference (SPID0- 5) is to be 
calculated as the SPID0- 5 divided by the total duration time..  
𝑁𝑜𝑟𝑚𝑎𝑙𝑖𝑧𝑒𝑑 𝑆𝑃𝐼𝐷0−5 =
∑
(𝑇𝑖−𝑇𝑖−1)∗𝑃𝐼𝐷𝑖
9
𝑖=1
𝑇9−𝑇0
, 
Visit 1
200 Subjects 
Randomization
Arm A:  FIRTECH Patch
100 randomized subjects
Arm B:  No Patch
100 randomized subjects
Visit 2 
End of Evaluation
Phone Follow -Up
End of Study
Day 1
Day 1 to Day 5
Day 5
Day 6
At Study Center:
*Subject enrollment
*e-diary activation
*Baseline assessments
*Randomization
*Patch application for 
Arm A
At Home
*Diary completion
At Study Center
*On-site 
assessments
*Patch removal
End of Study
Discharge

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where 𝑇0 = 0, 𝑇𝑖 – actual time and 𝑃𝐼𝐷𝑖 – Pain Intensity Difference score at time 
𝑇𝑖. Pain Intensity Difference, in turn, is defined as 𝑃𝐼𝐷𝑖= 𝑃𝐼𝑖−𝑃𝐼0 where 𝑃𝐼0 - 
Pain Intensity at time 𝑇0. 
 Roland-Morris Disability Questionnaire[5] (RMDQ) score improvement (%) from 
baseline to Day 5.  Details of the scoring of the Roland-Morris Disability 
Questionnaire are provided in Section 17.1. 
 Mobility evaluation[6,7]: change from baseline to Day 5.  The mobility evaluations 
(Schober’s Test or Fingertip to Floor Test) are described in Section 17.2. 
 Time to reach acceptable pain.  Time from randomization to the first report of 
acceptable pain; if that event never occurs, the tine will be censored at the final 
visit. 
Other secondary endpoints  
 Time to reach no pain (NRS = 0).  Time from randomization to the first report of 
NRS=0; if that event never occurs, the tine will be censored at the final visit. 
 Time course of PID (see above) over time from baseline to Day 5 on-site 
evaluation  
 Time course of Pain relief over time from baseline to Day 5 (VRS) 
 Normalized Sum of Pain relief over 5 days (TOTPAR0- 5).  Total pain relief 
(TOTPAR) is calculated by multiplying the pain relief score at each post-dose 
time point by the duration (in hours) since the preceding time point.  The 
Normalized Sum of Pain Relief (TOTPAR0- 5) is to be calculated as the Total Pain 
Relief divided by the total duration time.  
𝑁𝑜𝑟𝑚𝑎𝑙𝑖𝑧𝑒𝑑 𝑇𝑂𝑇𝑃𝐴𝑅0−5 =
∑
(𝑇𝑖−𝑇𝑖−1)∗𝑃𝐴𝑅𝑖
9
𝑖=1
𝑇9−𝑇0
, 
where 𝑇0 = 0, 𝑇𝑖 – actual time and 𝑃𝐴𝑅𝑖 – Pain Relief score at time 𝑇𝑖. 
6.3.3 Exploratory Endpoints 
 Frequency of use of rescue medication  
 Description of “worst pain” evaluation  
 Description of “least pain” evaluation 
 Description of “average pain” evaluation 
6.3.4 Safety Endpoints 
Safety endpoints will include: 
 Incidence of Adverse Events 
 Incidence of Serious Adverse Events 
 Incidence of Treatment Emergent Adverse Events 

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6.4 
Study Population 
Study populations are defined in Section 8.1. 
6.4.1 Sample Size 
The efficacy of the patch will be assessed compared with no-patch use.  The primary 
endpoint is the occurrence of being a NRS-responder at Day 5 defined as ≥ 30% 
decrease from baseline of the instantaneous pain and no rescue medication.  The 
responder proportion in the “no-patch” arm is unknown, and a variety of proportions 
of responders are envisaged.  The targeted treatment effect size is medium (Cohen’s 
H ranging from 0.42 to 0.45).  Ninety evaluable subjects per group (180 evaluable 
subjects in total) are needed to reach 80% power, as shown in the following table. 
Table 2.  Power Calculations 
N per Group 
Alpha  
(2 sided) 
Responder Rate 
Cohen’s H 
No Patch 
Patch 
90 
5% 
10% 
27% 
0.449 
90 
5% 
20% 
39% 
0.422 
90 
5% 
30% 
51% 
0.432 
90 
5% 
40% 
61% 
0.423 
90 
5% 
50% 
71% 
0.433 
90 
5% 
60% 
80% 
0.422 
Powers are calculated using East 6.4 
 
Further assuming a dropout rate of 10%, the expected number of subjects to be 
randomized is a total of 200.  Subjects will be randomized 1:1 to the treatment and 
no patch arms.  The estimated number to be screened to achieve 200 randomized 
subjects is 260. 
6.4.2 Subject Recruitment 
Subjects will be recruited from the geographic areas served by the participating 
clinical sites.  Subjects will be recruited from the individual practices of the 
participating clinicians. 
6.4.3 Subject Screening 
Subject screening will be conducted to ensure that subjects meet the study inclusion 
and exclusion criteria.  Re-screening of subjects who have failed a previous 
screening will not be permitted.  Documentation will be required to confirm the 
following: 
 Subjects have not received non-pharmaceutical treatments such as 
physiotherapy, heat treatments or massage therapy within 12 hours prior to 

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enrollment. 
 Subjects have not received any medications for pain within the last 24 hours (48 
hours for diclofenac or corticosteroids) prior to enrollment.. 
 Subjects must not have received a spinal injection to treat back pain within 6 
months prior to enrollment. 
 Subjects must not have had surgery due to back pain or rehabilitation due to back 
pain within 12 months prior to enrollment. 
 Female Subjects of childbearing potential are not pregnant or breastfeeding.  A 
urine pregnancy test will be required to confirm. 
6.4.4 Prior and Concomitant Therapy or Medications 
6.4.4.1 Prior and Concomitant Therapies 
Subjects must not have received any therapeutic patches or medications for 
pain within the last 24 hours (48 hours for diclofenac or corticosteroids)  prior 
to enrollment. Subjects must not have received a spinal injection to treat back 
pain within 6 months prior to enrollment.  Subjects must not have had surgery 
due to back pain or rehabilitation due to back pain within 12 months prior to 
enrollment.  Subjects must not have received non-pharmaceutical treatments 
such as physiotherapy, heat treatments, massage therapy or acupuncture 
therapy within 12 hours prior to enrollment. 
6.4.4.2 Prior and Concomitant Medications 
Subjects will refrain from using analgesics and anti-inflammatory drugs 
except as described in Section 6.4.4.3 below during the course of their 
participation in this study.  
6.4.4.3 Rescue Medications 
During the study, subjects can be treated with up to 2 g of Paracetamol per 
day (rescue therapy) to be documented in the e-diary.  Any other analgesics 
and anti-inflammatory drugs as well as any non-pharmaceutical therapy are 
prohibited during the study duration, if a subject needs to use one of these 
options, it has to be documented in the e-diary. 
6.4.5 Inclusion Criteria 
Subjects will be eligible to participate in the study if all of the following conditions 
exist: 
1. Male or female subjects who are ≥18 years and < 65 years. 
2. Subjects suffering from mild to moderate acute low back pain. 

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 Low back pain (lumbar back pain) is defined as pain in the back from the 
level of the lowest rib down to the gluteal fold.  
Acute episode is defined as acute pain with less than 1 month duration.  
 With intensity ≤ 6 on 0-10 Numerical Rating Scale (NRS). 
6.4.6 Exclusion Criteria 
Subjects will be excluded from participation in the study if any of the following 
conditions exist: 
1. 
Subjects suffering from any neurological pathology which could be 
responsible of the pain. 
2. 
Subjects suffering from leg pain irradiation. 
3. 
Subjects suffering from chronic lumbar pain of any etiology. 
4. 
Subjects with chronic arthrosis and neurological symptoms   
5. 
Subjects experiencing recent significant trauma (i.e., injury related to a fall 
from a height or motor vehicle crash, or from a minor fall or heavy lifting in a 
subject with osteoporosis or possible osteoporosis), 
6. 
Subjects with major or progressive motor or sensory deficit, new-onset bowel 
or bladder incontinence or urinary retention, loss of anal sphincter tone, saddle 
anesthesia, history of cancer metastatic to bone, and suspected spinal infection. 
7. 
Subjects clinically diagnosed with anxiety and/or depression 
8. 
Subjects using any medication for their pain within the last 48 hours within 
enrollment into the study  
9.     Subjects taking any systemic medication for their pain within the last 24 hours 
(48 hours for diclofenac or corticosteroids).   
 
 
10. Subjects currently using recreational or illicit drugs or with a recent history of 
drug or alcohol abuse or dependence. 
11. Subjects with any other medical condition that would interfere with efficacy 
and safety assessments based on investigator’s judgment.  
12. Subjects 
having 
received 
non-pharmaceutical 
Lower 
Back 
Pain 
treatment(physiotherapy, heat treatment or massage) within 12 hours prior 
enrollment  
13. Subjects having received spinal injection back pain treatment within 6 months 
prior enrollment 
14. Subjects having received surgery due to back pain or rehabilitation due to back 
pain in the last 12 months  
15. Subjects with a known sensitivity to paracetamol  
16. Known cutaneous hypersensitivity to plaster  
17. Subjects participating in another clinical study within the past 30 days 

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18. Subjects who are pregnant or breastfeeding.  Contraception is mandatory 
19. Subjects having damaged, non-intact, or scarred skin in or near the point of 
patch application. 
20. Subjects having a known skin sensitivity. 
21. Subjects having impaired blood circulation. 
6.4.7 Exit / Discontinuation Criteria 
Subjects will exit the study if any of the following conditions exist: 
1. 
Subject voluntarily withdraws from the study. 
2. 
Subject death. 
3. 
Subject is non-compliant with the protocol (as defined in Section 7.9) 
4. 
Subject’s well-being, in the opinion of the Investigator, would be 
compromised by study continuation. 
5. 
Subject experiences an Adverse Event leading to voluntarily withdrawal 
and/or requiring withdrawal as per Investigator judgement. 
6.5 
Premature Termination or Suspension of the Study 
This study may be prematurely terminated or suspended if there is sufficient reasonable 
cause.  If the study is prematurely terminated or suspended, the Principal Investigator (PI) 
will promptly inform study participants, the Institutional Review Board (IRB), and the 
sponsor will provide the reason(s) for the termination or suspension.  Study participants 
will be contacted, as applicable, and be informed of changes to the study visit schedule. 
Circumstances that may warrant premature termination or suspension include, but are not 
limited to: 
 Determination of unexpected, significant, or unacceptable risk or residual risk to 
participants (as described in the risk analysis performed according to ISO EN 
14971). 
 Insufficient compliance to protocol requirements 
 Data that are not sufficiently complete and/or evaluable 
The Sponsor must suspend/terminate the study within 5 working days of that 
determination.  
 
7 
Study Procedures 
7.1 
Informed Consent 

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All subjects for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study.  The consent form will be submitted with the protocol for review 
and approval by the IRB for the study.  The formal consent of a subject, using the IRB-
approved consent form, must be obtained before that subject is submitted to any study 
procedure.  This consent form must be signed by the subject or legally acceptable 
representative, and the investigator-designated research professional obtaining the consent.  
A blank copy of the IRB-approved form must be kept on-site and by the Investigator. 
7.2 
Vulnerable Populations 
Recognized vulnerable populations will not be targeted for recruitment, however 
individual subjects within vulnerable populations may be enrolled.  The Human Subject’s 
Protections procedures employed in this protocol are sufficient to protect the rights and 
welfare of any subject within an eligible vulnerable population and no additional measures 
are necessary. 
7.3 
Randomization Scheme 
Subjects will be randomized 1:1 to the investigational patch and no patch arms.  Specific 
randomization procedures will be described in a separate randomization plan. 
7.4 
Blinding / Unblinding   
This is an open label study, therefore there are no blinding / unblinding procedures. 
7.5 
Laboratory Testing Procedures 
The only laboratory procedure utilized will be a urine pregnancy test administered to 
women of child-bearing potential.   
7.6 
Clinical Procedures 
The study will be performed in Investigational Sites and an online e-diary will be used. 
A total of 2 site visits and 1 phone contact are planned during a maximum of 5 days of 
treatment and 6 days of total study duration. 
7.6.1 Day 1, Visit 1 
Clinical procedures on Day 1, Visit 1 include the following: 
 Verification of eligibility 
 Informed Consent Signatures 
 Local Physical Examination 

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 Collection of Vital Signs to include:   Respiratory rate, Heart rate, Temperature, 
Blood Pressure 
 Collection of Demographics to include:  Age , Gender 
 Collection of relevant medical history and concomitant medications 
 On-line daily e-diary will be explained and activated 
 Urine pregnancy testing (for women of childbearing potential only) 
 Causes and/or circumstances triggering the acute back pain 
 Baseline Subject symptom self-assessment 
o Pain Perception (NRS): Numerical Rating Scale[3] for pain assessments at 
baseline and at defined time points: 0-10 NRS; '0' representing “no pain” 
and '10' representing “worst pain imaginable 
 Instantaneous: pain at the moment of the evaluation 
 Average pain in the previous 12 hours. 
 Worst pain in the previous 12 hours 
 Least pain in the previous 12 hours 
o Roland-Morris Disability Questionnaire (RMDQ)[5] 
 Baseline mobility assessment (physician) 
 Randomization: 
o Arm A:  ITP FIRTECH:  Patch application according to the instruction for 
use in Section 17.3:  The patch has to stay in position for 5 days.  If the 
patch is taken-off or if it fell off during the study duration, the subject is 
invited to replace the patch at home following the instruction for use.  
Subject is allowed to take-off the patch at any time in case of severe skin 
itchiness, irritation, or skin reaction and in this case the subject has to 
contact the study center. 
o Arm B:  no-patch:  Subjects will be informed that they will not be assigned 
a patch in this study. 
 All subjects are informed that rescue mediation (paracetamol, up to 2 g per 
day), while not encouraged, is allowed if necessary.   
 All subjects will be informed of the prohibited medications. 
 If rescue medication is taken, the exact moment(s) and the dose(s) have to be 
indicated in the e-diary.   
 An explanation will be provided on how to use e-diary at home and providing 
all necessary access credentials 
 All subjects will be requested to avoid bed rest and will be recommended to 
continue with a normal daily life activity. 
 Two extra patches will be provided to the subjects. 
 Instruction will be provided on how to apply a patch at home, as per protocol 
Section 17.3. 

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7.6.2 Day 1 to Day 5, At Home 
The following procedures will take place while subjects are at home: 
 Completion of the e-diary in the morning (e.g. 8:00 [use 24 hr time format]) 
(this is not applicable at Day 1) 
o Pain perception (using NRS) 
 Instantaneous: pain at the moment of the evaluation 
 Average pain in the previous 12 hours. 
 Worst pain in the previous 12 hours 
 Least pain in the previous 12 hours 
o Pain relief (Using VRS) for the question “Do you feel pain relief?” 0= 
‘none’, 1= ‘slight’, 2= ‘moderate’, 3= ‘lots’, 4= ‘complete’. 
o Is the Pain acceptable (binary, Yes/No)? 
o Need of rescue medication (time and dose) 
 Completion of the diary in the evening (e.g. 20:00 [use 24 hr time format]) (this 
is not applicable at Day 5) 
o Concomitant therapies, if any 
o Daily activities to include showers, physical activities, sporting activities, 
etc. 
o Pain Perception (using NRS) 
 Instantaneous: pain at the moment of the evaluation 
 Average pain in the previous 12 hours. 
 Worst pain in the previous 12 hours 
 Least pain in the previous 12 hours 
o Pain relief (Using VRS) 
o Is the Pain acceptable? 
o Need of rescue medication (time and dose) 
o Adverse events 
o Need of patch removal and application of a new patch – according to 
instructions for use (Section 17.3) – and recording of reason. 
7.6.3 Day 5, Visit 2 Patch Removal / End of Treatment 
Clinical procedures on Day 5, Visit 2 (Investigational Site) include the following: 
 Completion of the e-diary on site 
o Pain perception (using NRS) 
 Instantaneous: pain at the moment of the evaluation 
 Average pain in the previous 12 hours. 
 Worst pain in the previous 12 hours 
 Least pain in the previous 12 hours 
o Pain relief (Using VRS) 

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o Is the Pain acceptable? 
o Need of rescue medication (time and dose) 
o Adverse Events 
o Concomitant therapies if any 
 E-Diary verification 
 Arm A Subjects: Patch is removed. 
o Collection of all used and unused patches. 
 Arm B Subjects: subjects are informed about the end of the evaluation period 
 Local physical examination, including at patch localization (only for Arm A 
subjects) 
 Vital signs 
 Roland-Morris Disability Questionnaire (RMDQ)[5] 
 Mobility assessment (physician) 
7.6.4 Day 6, Phone Contact:  End of Study 
Day 6, follow-up procedures by phone include: 
Safety contact for evaluating any Adverse Events and the need or not for a safety 
extra visit as per Investigator judgement. 
7.6.5 Unscheduled Visit 
Unscheduled visits may occur for any reason if the subject or the investigator 
consider that it is necessary.  The reason and the performed procedures will be 
collected in the CRF.  
7.7 
Follow-Up Procedures and Therapy Transitions 
There are no longer-term follow-up or therapy transition procedures. 
7.8 
Study Timetable / Schedule of Events 
Table 3.  Schedule of Events 
Visits 
V1 
At 
Home 
V2 
Phone 
Call 
Unsch 
Notes 
Days 
D1 
D1 to 
D5 
D5 
D6 
 
Eligibility verification 
 
 
 
 
 
 
Informed Consent  
 
 
 
 
 
 
Demographics / 
Medical History 
 
 
 
 
 
 
Physical Exam 
 
 
 
 
 
 
Vital Signs 
 
 
 
 
 
 

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Visits 
V1 
At 
Home 
V2 
Phone 
Call 
Unsch 
Notes 
Days 
D1 
D1 to 
D5 
D5 
D6 
 
Urine Pregnancy Test 
 
 
 
 
 
For women of child-bearing 
potential only 
E-diary Activation 
 
 
 
 
 
 
Randomization 
 
 
 
 
 
 
E-diary Completion 
 
* 
** 
 
 
*2 times per day at the same 
times 
**On-site evaluations 
Pain perception 
 
 
 
 
 
 
Pain-relief evaluation 
 
 
 
 
 
 
Pain acceptable 
perception 
 
 
 
 
 
 
Rescue Medication 
Needed 
 
 
 
 
 
 
Roland-Morris 
Disability Questionnaire 
 
 
 
 
 
 
Mobility assessment 
 
 
 
 
 
Schober’s Test or Fingertip-
to-floor test 
Adverse Event 
assessment 
 
 
 
 
 
 
Patch application / 
removal 
 
 
 
 
 
Patch(es) has(have) to be 
used for 5 days.  
 
If the patch is taken-off 
for a safety reason, the 
subject has to contact the 
study center. 
 
If the patch falls off, the 
subject has to replace it 
as soon as possible  
The subject will complete the 
diary card, informing about 
the patch replacement, the 
reason of change, and the 
time spent with no patch.  
Concomitant therapies 
 
 
 
 
 
 
e-diary review 
 
 
 
 
 
 
 
 
 

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7.9 
Study Protocol Compliance / Treatment Adherence 
Subject compliance to the protocol will be defined as  
 Subjects comply with study visit schedule 
 Subjects complete the e-diary as instructed 
Subjects will be considered compliant if they complete at least 80% of the required e-diary 
entries, and attend all scheduled visits.  Non-complaint subjects will not be replaced.  
Compliance to the e-diaries does not impact the primary endpoint, as that is determined as 
a change from baseline.  
7.10 Deviations from the Clinical Protocol 
When a deviation from the protocol is identified for an individual subject, the investigator 
must document the deviation on a Protocol Deviation Form and contact the sponsor (or its 
acting representative).  A description of the deviation from the protocol and justification 
must be recorded on the Protocol Deviation Form. 
7.11 Subject Withdrawal 
7.11.1 Subject Withdrawal 
Subjects who withdraw (or are withdrawn) will not be replaced.  Subjects may be 
withdrawn from the study for any of the reasons described in Section 6.4.7.  Upon 
withdrawal, subjects will, if possible, be assessed by the Day 5 procedures for study 
exit.  Termination of the study treatment does not affect subject safety, therefore no 
termination specific procedures are required.  Termination of study treatment does 
not require any specific therapy or treatment transitions. 
7.11.2 Data Collection and Follow-Up for Withdrawn Subjects 
Subjects who withdraw or are withdrawn from the study will not be replaced.  Data 
collected prior to the withdrawal will be maintained and included in the data 
analysis.   
7.12 Subject Compensation 
Subject compensation for study participation will be detailed in the Informed Consent. 
8 
Data Collection and Analysis 
A separate Statistical Analysis Plan (SAP) will be prepared for this study which will contain a 
detailed description of the statistical analysis.  The SAP will be approved by the sponsor and 
the SAP sign-off will take place before the database lock.  The sections below provide an 
overview and summary of the analyses to be detailed in the Statistical Analysis Plan. 

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8.1 
Subject Descriptions 
The Clinical Study Report will provide data listings at a per subject level.  Demographics 
and baseline characteristics data will be summarized and reported using descriptive 
statistics (means, standard deviations, and ranges for quantitative variables and frequencies 
and percentages for qualitative variables) for each patch group for all subjects.  Prior and 
concomitant therapies and medications will be included in the subject data listings, and 
will be summarized as per randomized assignment.   
Protocol deviations will be listed by subject and summarized for each patch group by 
deviation type.  Protocol deviations will also be reviewed for trends.  Endpoint data will 
be summarized and analyzed as described below (Section 8.3). 
8.2 
Subject Population(s) for Analysis 
The subject populations for analysis include the following: 
 The Intent-To-Treat (ITT): any subject randomized into the study, regardless of 
compliance with study procedures. 
 Evaluable for Efficacy: any subject randomized into the study that had the NRS 
evaluation done at baseline and day 5. 
 Safety: any subject randomized into the study and, if randomized to the “patch” arm, 
had the device installed. 
8.3 
Statistical Methods 
Descriptive analyses will include summary statistics (using n, mean, standard deviation, 
inter quartile range, median, minimum, and maximum) for quantitative variables or 
number and percentage of subjects in each category for qualitative data. When requested, 
all statistical tests will be conducted at 2-sided using 5% alpha level. Besides, multiplicity 
for secondary parameters will be considered in the SAP. 
8.3.1 Efficacy Analyses 
8.3.1.1 Primary Analysis 
Descriptive analysis will be conducted for the instantaneous pain on NRS (A 
Numerical Rating Scale[3]).  The summary statistics will be presented for 
observed values at Day 5 and change from baseline to Day 5 for each group 
(patch, no-patch).  
The rate of NRS-responders at Day 5 where NRS-response is defined as ≥ 
30% decrease from baseline of the instantaneous pain and no rescue 
medication will be presented descriptively for each group (patch, no-patch), 
along with an associated 95% confidence interval.  

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The hypothesis that there is no difference in the rate of responders will be 
tested between the group with patch and no-patch group at Day 5 using 
Fisher’s exact test and presented with its associated p-value.  
8.3.1.2 Secondary Analyses 
Under the secondary analyses (key and other), descriptive and inferential 
analysis, where applicable, will be conducted for the following:  
 Normalized Sum of Pain Intensity Difference (SPID0-5): the descriptive 
and inferential analyses will be conducted for Day 5.   
 Roland-Morris Disability Questionnaire[5] (RMDQ) score: descriptive 
analysis will be conducted for the observed values at baseline and Day 5, 
as well as for change (improvement (%)) from baseline to Day 5. 
Inferential analysis will be conducted for change (improvement (%)) from 
baseline to Day 5. 
 Mobility evaluation[6,7]: descriptive analysis will be conducted for the 
observed values at baseline and Day 5, as well as for change from baseline 
to Day 5. Inferential analysis will be conducted for change from baseline 
to Day 5. 
 Time to reach acceptable pain and time to reach no pain: descriptive and 
inferential analysis will be conducted based on the data obtained in 
between baseline and final visit assessments. 
 Normalized Sum of Pain relief (TOTPAR0- 5): the descriptive and 
inferential analyses will be conducted for Day 5. 
 Time course of PID and time course of Pain relief (VRS):   descriptive 
analysis will be conducted for the observed values from baseline to Day 5.  
 Frequency of Adverse Events: descriptive analysis will be conducted 
based on the data obtained in between baseline and final visit.  
The inferential analysis for the Normalized Sum of Pain Intensity Difference 
(SPID0-5), Roland-Morris Disability Questionnaire[5] (RMDQ) score, 
Mobility evaluation[6,7] , Normalized Sum of Pain relief (TOTPAR0- 5), will 
be based on the analysis of covariance (ANCOVA) model with the group 
(patch, no-patch) as fixed effect and baseline pain intensity as a continuous 
covariate.  The Least-Square Means, Standard Errors and 95% Confidence 
Intervals for each group (patch, no-patch) will be estimated and provided, 
along with the Least-Square Means, Standard Errors and 95% Confidence 
Intervals for the difference between group with patch and no-patch group.  
Additional effects will be added to the model in case of need.  

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The inferential analysis of time-to-event endpoints (time to reach acceptable 
pain, time to reach no pain) will include summary, display, and analysis using 
Kaplan-Meier estimation method. The comparison of survival distributions 
between the group with patch and no-patch group will be done by the Log-
Rank test.  During the analysis, if the event if interest never occurs, the time 
will be censored at the final visit. 
These analyses will be based on the ITT population, using the ITT paradigm 
(i.e. as randomized). 
8.3.1.3 Exploratory Analyses 
The exploratory analyses will consist from:  
 Assessing the frequency of use of Rescue Medication: descriptive analysis 
will be conducted for the observed values at baseline, baseline to Day 5 
period and Day 5 assessments (through eDiary entries).  
 Descriptions of “worst pain”, “least pain” and “average pain”: descriptive 
analysis will be conducted for the observed values at baseline, baseline to 
Day 5 period and Day 5 assessments, as well as for change from baseline 
to Day 5.  
Inferential analysis for description of “worst”, “least” and “average” pain will 
be conducted similar to secondary endpoints analysis for change from 
baseline at Day 5 using analysis of covariance (ANCOVA) model.  
8.3.1.4 Compliance Analysis 
8.3.1.4.1 
eDiary Compliance (%) 
Compliance will be measured based on the completion of e-Diaries.  Subject 
will be considered as compliant if at least 80% of e-Diaries are completed, 
otherwise, if less than 80% of e-Diaries are completed, subject will be 
considered as non-compliant.  
Descriptive statistics (e.g. mean, median, etc.) will be provided for the 
compliance (%), as well as summarized in categories: “<80%”, “80% - 
100%” using frequency tables.  The number and percentage of compliant and 
non-compliant subjects will be presented as well, using the ITT paradigm (i.e. 
as randomized) and safety populations. 
8.3.1.4.2 
Patch use Compliance (Days) 
Patch Use Compliance will be measured based on the number of days subject 
wears a patch.  Subject will be considered as compliant if a patch is worn at 

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least for 4 days.  Otherwise, if less subject wears a patch for less than 4 days, 
subject will be considered as non-compliant.  
Descriptive analysis will be conducted for Patch Use Compliance (Days), as 
well as Patch Use Compliance (Days) will be summarized in categories: “1 
day”, “2 days”, “3 days”, “4 days”, “5 days” and “>5 days” using frequency 
tables.  The number and percentage of compliant and non-compliant subjects 
will be presented as well, using the ITT paradigm (i.e. as randomized). 
8.3.1.5 Adjustments for Multiple Testing 
Adjustment for multiple testing will be done as follows: 
 The multiplicity of key secondary endpoints will be handled using a False 
Discovery Rate (FDR) approach.  Nominal p-values will also be displayed. 
 For the other secondary endpoints and the exploratory endpoints, p-values 
will be provided for descriptive purpose only. 
 The number of adverse events defined as other secondary endpoint will be 
analyzed only with descriptive statistics (no p-value will be provided). 
8.3.2 Safety Analyses 
8.3.2.1 Adverse Events 
Adverse events are defined as listed in Section 9.1.  Adverse event reporting 
for the purposes of regulatory compliance is described in Section 9.4.   
The Adverse Events will be summarized by frequencies and percentages of 
subjects with at least one AE and presented in the Clinical Study Report using 
the Safety population and the “as treated” paradigm (i.e. according to if they 
actually had a patch installed, or not).  
8.3.2.2 Other Safety Analyses 
Safety assessments (Vital Signs, Physical Examination, etc.), concomitant 
medications and procedures, will be reported using descriptive statistics, if 
applicable, and frequencies and percentages.  The safety summaries will be 
based on the Safety population and under the “as treated” paradigm (i.e. 
according to if they actually had a patch installed, or not). 
 
 

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9 
Safety and Adverse Events 
9.1 
Definitions 
Standard definitions for utilization in medical device trials are provided below.  
Adverse Event (AE) 
Adverse Event shall mean any untoward medical occurrence in a patient who takes or 
uses a product, and which does not necessarily have a causal relationship with that 
product.  An Adverse Event can therefore be any unfavorable and unintended sign 
(including an abnormal laboratory finding, for example), symptom, or disease, 
temporally associated with the use of such a product, whether or not considered related 
to that product. 
Serious Adverse Event (SAE) 
Serious Adverse Event is any untoward occurrence occurring in a clinical trial or a 
performance evaluation subject to authorization which has led, could have led or could 
lead, directly or indirectly, to the death of a subject, a user or another person or to a 
serious deterioration in their state of health, without regard to whether the event was 
caused by the medical device.   
Important medical events are events that may not be immediately life-threatening, but 
are clearly of major clinical significance and may be SAEs.  They may jeopardize the 
subject, and may require intervention to prevent one or the other serious outcomes noted 
above.   
Incident 
Incident means any malfunction, failure, change in the characteristics or performance or 
improper labelling or instructions for use of a medical device which has led, could have 
led or could lead directly or indirectly to death or to a serious deterioration in the state of 
health of a patient, user or other person; a malfunction shall also be deemed to be a defect 
in usability which causes misuse. 
Treatment Emergent Adverse Event (TEAE) 
A treatment emergent adverse event is an event that emerges during treatment (as defined 
in Section 7.6), having been absent pretreatment, or worsens relative to the pretreatment 
state. 
Hospitalization  
Hospitalization shall include any initial admission (even if less than 24 hours) to a 
healthcare facility as a result of a precipitating clinical adverse effect; to include transfer 
within the hospital to an intensive care unit.  Hospitalization or prolongation of 
hospitalization in the absence of a precipitating, clinical adverse effect (e.g., for a 
preexisting condition not associated with a new adverse effect or with a worsening of the 

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preexisting condition; admission for a protocol-specified procedure) is not, in itself, a 
serious adverse effect. 
Unanticipated Adverse Device Effect (UADE) 
An unanticipated adverse device effect is any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, a device, if that 
effect problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan, or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects. 
Adverse Event Relationships to the Study Device 
The relationships between adverse events and the study device will be characterized by 
the definitions below. 
 Unrelated:  This category applies to those adverse events which, after careful 
consideration, are clearly and incontrovertibly due to extraneous causes (disease, 
environment, etc.) 
 Possibly Related:  This category applies to those adverse events for which, after 
careful medical consideration at the time they are evaluated, a connection with the 
study device administration appears unlikely but cannot be ruled out with certainty.  
An adverse experience may be considered possibly related if or when (at least two 
of the following): 
o It follows a reasonable temporal sequence from administration of the study 
device. 
o It could not readily have been produced by the subject’s clinical state, 
environmental or toxic factors, or other modes of therapy administered to the 
subject. 
o It follows a known pattern of response to the study device. 
 Probably Related:  This category applies to those adverse events which, after careful 
medical consideration at the time they are evaluated, are felt with a high degree of 
certainty to be related to the study device.  An adverse experience may be considered 
probably related if or when (at least three of the following): 
o It follows a reasonable temporal sequence from administration of the study 
device. 
o It could not be reasonably explained by the known characteristics of the subject’s 
clinical state, environmental or toxic factors or other modes of therapy 
administered to the subject. 
o It disappears or decreases on cessation or reduction in device exposure.  There 
are important exceptions when an adverse event does not disappear upon 
discontinuation of the device, yet device-relatedness clearly exists. 
o It follows a known pattern of response to the study device. 

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 Definitely Related:  An adverse event may be considered definitely related if or 
when 
o The event is a known effect of the device, or procedure 
o The event follows an obvious sequence of time, from the device’s implantation 
or activation, or procedure, for which the event is directly attributed to the 
administration, implantation, activation, or procedure. 
o The event ceases with discontinuation of the device, or procedure (and reoccurs 
on restarting). 
Device Malfunction/Failure – Device Specific Events 
A device specific event (DSE) is any malfunction of the device, related or not to the 
device, resulting or not in the subjects undergoing undesirable or harmful experience, 
that occurs in relation with the conduct of the study. 
Device malfunction means the failure of a device to meet its performance specifications 
or otherwise perform as intended.  Performance specifications include all claims made 
in the labeling for the device.  The intended performance of a device refers to the intended 
use for which the device is labeled or marketed. 
Refer to trouble shooting guide (to be provided by Sponsor) to identify device 
malfunction/failure and for subsequent steps. 
Device malfunction may or may not result in the subject experiencing a harmful effect. 
All AEs/SAEs associated with a device failure are by definition device related. 
9.2 
Safety Monitoring Plan 
Procedures for ensuring subject safety are addressed throughout this protocol, and a 
separate Data Safety Monitoring Plan will not be required.  Any incidental findings 
associated with clinical procedures will be provided to the subject with a recommendation 
for follow-up with their primary physician.  The site Principal Investigator, or designee, 
will serve as the Emergency Medical Safety Contact for subject enrolled at that site. 
9.2.1 Anticipated Risks / Risk Mitigation 
The anticipated risks associated with this clinical protocol include minor skin 
hypersensitivity reactions such as skin irritation due to the patch adhesive.  This risk 
is considered minor and will be assessed at patch removal and/or if the patch is 
removed prior to study completion.  Risk is mitigated by patch removal as soon as 
such reactions are detected. 
9.2.2 Medical Monitoring for Participant Safety 

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The Principal Investigator will oversee the safety of the study, including careful 
assessment and appropriate reporting of adverse events as outlined in Section 9.4.  
Medical monitoring will include a regular assessment of the number and type of 
serious adverse events.  The Medical Monitor will be appointed by the Sponsor or 
the Sponsor’s CRO designee. 
9.3 
Anticipated Adverse Events 
No Serious Adverse Events are anticipated for this trial.  Anticipated adverse events 
include minor skin irritation at the site of patch application as described above.  The 
frequency of occurrence of skin irritation is unknown.   
9.4 
Adverse Event Reporting 
All Adverse Events occurring during the study period must be recorded and reported to the 
Sponsor within 24 hours.  The clinical course of each event will be followed until 
resolution, stabilization, or until it has been determined that study treatment or participation 
is not the cause.   
The Investigator will promptly review documented adverse effects and abnormal test 
findings to determine:  
1) if the abnormal test finding should be classified as an adverse effect;  
2) if there is a reasonable possibility that the adverse effect was caused by the 
investigational device or, if applicable, other study treatment or diagnostic 
product(s); and  
3) if the adverse effect meets the criteria for a serious adverse effect. 
If the Investigator’s final determination of causality is “unknown and of questionable 
relationship to the investigational device or, if applicable, other study treatment or 
diagnostic product(s)”, the adverse effect will be classified as associated with the use of 
the investigational device or study treatment or diagnostic drug product(s) for reporting 
purposes.  If the investigator’s final determination of causality is “unknown but not related 
to the investigational device or, if applicable, other study treatment or diagnostic 
product(s)”, this determination and the rationale for the determination will be documented 
in the respective subject’s case history. 
9.4.1 Adverse Events 
All observed or volunteered adverse effects and abnormal test findings, regardless 
of treatment group, if applicable, or suspected causal relationship to the 
investigational device or, if applicable, other study treatment or diagnostic 
product(s) will be recorded in the subjects’ case histories.  For all adverse effects, 
sufficient information will be pursued and/or obtained so as to permit:  

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1) 
an adequate determination of the outcome of the effect (i.e., whether the effect 
should be classified as a serious adverse effect) and;  
2) 
an assessment of the casual relationship between the adverse effect and the 
investigational device or, if applicable, the other study treatment or diagnostic 
product(s).    
Adverse effects or abnormal test findings felt to be associated with the 
investigational device or, if applicable, other study treatment or diagnostic 
product(s) will be followed until the effect (or its sequelae) or the abnormal test 
finding resolves or stabilizes at an acceptable level. 
Adverse Events that do not qualify as Serious Adverse Events, or as Unanticipated 
Adverse Device Effects will be reported to the Sponsor at designate interval 
determined by the Sponsor. 
Adverse Events that do not qualify as Serious Adverse Events, or as Unanticipated 
Adverse Device Effects will be reported the IRB with the continuing review 
progress report.   
9.4.2 Serious Adverse Events 
Investigators must report serious adverse events to the Study Sponsor within 24 
hours of learning of the event.  A serious adverse event form must be completed by 
the Investigator and faxed to the Study Sponsor or designee within 24 hours.  Study 
Sponsor contact information for Serious Adverse Event Notification: 
 
ICON Clinical Research 
 
888-723-9952 (Telephone) 
At the time of the initial report, the following information should be provided: 
 Study Identifier 
 Whether study treatment was discontinued 
 Study Center 
 Reason the event is classified as serious 
 Subject Number 
 Investigator 
assessment 
of 
association 
between event and study device 
 Event Description 
 Date of Onset 
 Current Status 
 
Serious Adverse Events that are at least possibly related must be reported to the 
IRB/EC within 10 working days.   
 
 

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9.4.3 Unanticipated Adverse Device Effects (UADE) 
Investigators are required to submit a report of a UADE to the Sponsor and the 
reviewing IRB as soon as possible, but in no event later than 10 working days after 
the Investigator first learns of the event.  
Sponsors must immediately conduct an evaluation of a UADE and must report the 
results of the evaluation to all reviewing IRB/ECs, and participating Investigators 
within 10 working days after the Sponsor first receives notice of the effect. 
If the Adverse Event is Serious, Unanticipated, Device Related, and determined by 
the Sponsor to present an unreasonable risk to subjects, the Sponsor must terminate 
the study within 5 working days of that determination. 
10 Data Handling and Record Keeping 
10.1 Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the General Data Protection Requirements (GDPR).  Those regulations 
require a signed subject authorization informing the subject of the following:  
 What protected health information (PHI) will be collected from subjects in this study 
 Who will have access to that information and why 
 Who will use or disclose that information 
 The rights of a research subject to revoke their authorization for use of their PHI.  
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of 
subject authorization.  For subjects that have revoked authorization to collect or use PHI, 
attempts should be made to obtain permission to collect at least vital status (i.e. that the 
subject is alive) at the end of their scheduled study period. 
10.2 Source Documents 
Source Data are the clinical findings and observations, laboratory and test data, and other 
information contained in Source Documents.  Source Documents are the original records 
(and certified copies of original records); including, but not limited to, hospital medical 
records, physician or office charts, physician or nursing notes, subject diaries or evaluation 
checklists, pharmacy dispensing records, recorded data from automated instruments, x-
rays, etc.  When applicable, information recorded on the CRF shall match the Source Data 
recorded on the Source Documents. 
 

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10.3 Case Report Forms and e-diaries 
The study case report form (CRF) and the e-diary are the primary data collection 
instruments for the study.  All data requested on the CRF must be recorded.  All missing 
data must be explained.   
A Case Report Form will be completed for each subject enrolled into the clinical study.  
The investigator-sponsor will review, approve and sign/date each completed CRF; the 
investigator’s signature serving as attestation of the investigator’s responsibility for 
ensuring that all clinical and laboratory data entered on the CRF are complete, accurate 
and authentic.  The electronic system used for data recording will provide for electronic 
signatures and audit traceability.  
E-diaries for subject self-reported data will be maintained independent of the CRFs.  E-
diary information will be captured in a separate database and will be reviewed for 
completeness. 
10.4 Clinical Reports 
The clinical study reports that will be developed for this study include the Final Clinical 
Study Report to be submitted to governing IRB/ECs.  The Sponsor will be responsible for 
the preparation of the final Clinical Study Report.  The final Clinical Study Report will be 
prepared within 90 days of trial completion. 
10.5 Records Retention  
The investigator will retain the specified records and reports for 25 years after the 
completion of the study.  Investigators will notify the Sponsor at least 30 days prior to any 
scheduled destruction of records.   
11 Study Monitoring, Auditing, and Inspecting 
This study will be monitored according to Good Clinical Practice guidelines.  The Investigator 
will allocate adequate time for such monitoring activities.  The Investigator will also ensure that 
the monitor or other compliance or quality assurance reviewer is given access to all study-
related documents and study related facilities (e.g. pharmacy, diagnostic laboratory, etc.), and 
has adequate space to conduct the monitoring visit. 
11.1 Study Monitoring Plan 
ICON will conduct monitoring visits at study initiation, study completion, and during the 
study as required.  During these visits the monitor/s will review all aspects of the study to 
ensure that the CIP and applicable regulatory requirements and ISO14155:2011 standard 
are adhered to.  Monitoring activities will include checking CRFs and verifying data 

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against source documentation, reviewing ICFs, checking the Device Accountability Log, 
and ensuring that the Site Study File is up to date and contains all the required 
documentation.  ICON CRAs will be contacting sites regularly to ensure continuous 
oversight of study process and follow-up on action items.  Independent monitoring of the 
clinical study for clinical protocol compliance will be conducted periodically by qualified 
staff.  In consideration of COVID-19 pandemic issues, where possible/feasible remote 
source data verification, remote monitoring and remote investigational site closure visits 
may be employed. 
11.2 Auditing and Inspection 
The investigator will permit study-related monitoring, audits, and inspections by the 
IRB/EC, the sponsor, government regulatory bodies, and institutional compliance and 
quality assurance groups of all study related documents (e.g. source documents, regulatory 
documents, data collection instruments, study data etc.).  The investigator will ensure the 
capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic 
laboratory, etc.). 
Participation as an investigator in this study implies acceptance of potential inspection by 
government regulatory authorities and applicable institutional compliance and quality 
assurance offices. 
12 Protocol Amendments After Study Initiation 
Should changes in the study plan or protocol become necessary in the course of the clinical 
trial, those specific changes will be discussed and agreed upon by the Sponsor, its acting 
representative if appropriate, Investigator, and appropriate IRB/EC approval obtained before 
the changes are implemented.  All changes must be documented as protocol amendments.   
13 Ethical Considerations 
This study is to be conducted according to US and international standards of Good Clinical 
Practice, applicable government regulations and Institutional research policies and procedures. 
This protocol and any amendments will be submitted to a properly constituted independent 
Institutional Review Board/Ethics Committee (IRB/EC), in agreement with local legal 
prescriptions, for formal approval of the study conduct.  The decision of the IRB/EC concerning 
the conduct of the study will be made in writing to the investigator and a copy of this decision 
will be provided to the Sponsor before commencement of this study.   
14 Study Finances 
14.1 Funding Source 

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This study is funded by Sanofi Aventis Groupe. 
14.2 Conflicts of Interest 
Conflicts of interest or perceived conflicts of interest will be addressed in accordance with 
the policies of the participating institutions. 
15 Publication Plan 
Neither the complete nor any part of the results of the study carried out under this protocol, nor 
any of the information provided by the sponsor for the purposes of performing the study, will 
be published or passed on to any third party without the consent of the study sponsor.  Any 
investigator involved with this study is obligated to provide the sponsor with complete test 
results and all data derived from the study. 
16 References 
1. Guideline on the clinical development of medicinal products intended for the treatment of 
pain European Medicines Agency, 2016; EMA/CHMP/970057/2011 
2. McIntosh G, and Hall H. Low back pain (acute). Clinical Evidence 2011:05:1102. PMCID: 
PMC3217769 
3. McCaffery, M., Beebe, A., et al. (1989). Pain: Clinical manual for nursing practice, Mosby 
St. Louis, MO. 
4. Dworkin RH, Turk DC, et al.  Interpreting the clinical importance of group differences in 
chronic pain clinical trials: IMMPACT recommendations.  Pain 2009; 146:238-244. 
5. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. 
Spine 2000; 25: 3115-3124. 
6. Schober P (1937). "Lendenwirbelsäule und Kreuzschmerzen". Much Med Wochenschr. 84: 
336–339. 
7. Perret C, Poiraudeau S, Fermanian J, Colau MM, Benhamou MA, Revel M. Validity, 
reliability, and responsiveness of the fingertip-to-floor test. Archives of Physical Medicine 
and Rehabilitation 2001;82(11):1566-70. 
17 Appendices and Attachments 
17.1 Roland-Morris Low Back Pain and Disability Questionnaire 
The Roland-Morris Disability Questionnaire (RMDQ) is a self-administered disability 
measure in which greater levels of disability are reflected by higher numbers on a 24-point 
scale.  The RMDQ has been shown to yield reliable measurements, which are valid for 
inferring the level of disability, and to be sensitive to change over time for groups of 
subjects with low back pain. 

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Scoring instructions  
Interpretation of scores  
Roland and Morris did not provide descriptions of the varying degrees of disability (e.g. 
40%-60% is severe disability).  Clinical improvement over time can be graded based on 
the analysis of serial questionnaire scores.  If, for example, at the beginning of treatment, 
a subject’s score was 12 and, at the conclusion of treatment, their score was 2 (10 points 
of improvement), we would calculate an 83% (10/12 x 100) improvement.  

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17.2 Mobility Test 
Mobility will be tested by Schober’s Test or Fingertip-To-Floor Test.  The choice of the 
test used for the mobility assessment will be done depending on the feasibility study. 
SCHOBER’S TEST 
Procedure 
 Subject is standing, examiner marks the L5 spinous process by drawing a horizontal 
line across the subject’s back. 
 A second line is marked 10 cm above the first line. 
 Subject is then instructed to flex forward as if attempting to touch his/her toes, 
examiner re-measures distance between two lines with subject fully flexed. 
FINGERTIP-TO-FLOOR TEST [Perret 2001] 
The procedure for Fingertip-to-floor (FTF) test follow the recommendation of the 
American Psychological Association: the subject stood erect on a platform 20-cm high 
with shoes removed and feet together. He/she was asked to bend forward as far as 
possible, while maintaining the knees, arms, and fingers fully extended. The vertical 
distance between the tip of the middle finger and the platform is measured with a supple 
tape measure and is expressed in centimeters. The vertical distance between the platform 
and tip of the middle finger is positive when the subject did not reach the platform and 
negative when he could go further.  
 
 

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17.3 Instructions for Patch Use 
BEFORE APPLYING THE PATCH 
 The patch should be applied to undamaged, clean, dry, non-oily skin.   
 Too greasy or creamy skin or too much body hair can impair the adhesion of the 
patch. Appropriate preparation of the skin in the area of application will increase the 
useful life of the patch. 
 
How to prepare the skin:  
Clean the skin to remove any dirt, lotions, oils, or powders.  
  Use warm water alone or with a clear soap, if possible  
  Dry the skin with a clean towel or paper towel. 
If you used any oily cream/ointment before (for example, a moisturizer), be sure that the 
skin is not oily anymore. 
The area should not contain excessive hair 
 
HOW TO APPLY THE PATCH  
Closely follow the application instructions 
Ask someone to help you apply the patch correctly, if needed 
 
STEP 1. What to take care for: 
 Slightly bend over to stretch the lower back skin. This increases the adherence of 
the patch. 
 

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STEP 2.  
 Precisely locate zone for patch application as indicated on the picture: place the 
patch in the lower back region. 
 
 
 
STEP 3. The application of the patch. Ask someone to help on this step 
Open the package carefully and take out the patch 
 Remove the central part (1) of the transparent protective film and place the patch 
in the center of the defined pain area. Press the patch firmly into place. Be careful 
not to touch the adhesive surface of the patch.  
 Remove the second part (2) of the transparent protective film, stretch this side of 
the patch a little and immediately place it on the skin and press it firmly. 

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 Now remove the last part (3) of the transparent protective film, stretch this side of 
the plaster a little and immediately place it on the skin and press it firmly. 
 
Press the patch for 30 seconds to make sure it’s firmly attached to your skin: using the 
palm of your hand, press down firmly on the whole patch, use your fingers to press along 
the edges.  
The patch should be smooth, with no bumps, folds or air bubbles.  If the patch is not stuck 
well, do not re-stick it – use another patch instead.  
 
 
AFTER APPLYING THE PATCH 
Keep the patch on your skin and continue your life normally.  
Patch doesn’t produce any warming or cooling effect – it is non-noticeable while wearing. 
Please note that even if edges start to peel off, you can still keep the patch on the skin for 
up to 5 days  
In case the first patch falls off, apply the second patch to the same area, closely following 
the instructions again. 
Recommendations:  
 The patch is water-resistant, which means that it remains active even when it is wet. 
You can shower with it. After you shower, gently pat the patch dry with a towel 
without rubbing. 
 Avoid very hot water, sauna, steam bath, bathing or swimming, as this can cause the 
patch to peel off. 
 Avoid to wear tight clothes that can increase the risk of the patch peeling off. 
 Avoid to apply any oily substance on the patch area during the time when you are 
wearing the patch  
 
How to peel off the patch on Day 5: 

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Remove the patch by gently lifting one end and dispose as household waste. Do not reuse.. 
Warnings 
 Store at room temperature. 
 For external use only. 
 Apply only to clean, dry, undamaged skin. 
 Discontinue treatment in the event of evident irritation or hypersensitivity to the 
product. 
 In case of specific blood circulation or muscular problems, seek the advice of your 
doctor before applying the plasters. 
 Keep out of the reach of children. 
 The patch should only be used by adults (> 18 years old). 
 Do not use if the packaging is broken or punctured since damaged packaging could 
compromise efficacy and safety of the product 
 Should not be used for pregnant or lactating women 
 (Read the instructions for use)  
 
 
 
 
 
 
 
 
 
 
 
 
 

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