Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss and/or Appetite Suppression
Phase: NA
Conditions: Weight Loss
Sponsor: Elira Therapeutics, Inc.

1 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
 
 
ELIRA -2 Trial 
 
 
Safety and Effectiveness of Transcutaneous Electrical 
Nerve Stimulation (TENS)-Assisted Weight Loss and/or 
Appetite Suppression 
 
 
Protocol Number: CD-005 
Original Date May 8, 2018 
Version:  4.0 
Revised Date: May 3, 2019 
 
 
 
 

2 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
ELIRA-2 
SAFETY AND EFFECTIVENESS OF TRANSCUTANEOUS ELECTRICAL NERVE 
STIMULATION (TENS)-ASSISTED WEIGHT LOSS AND/OR APPETITE 
SUPPRESSION 
 
Sponsor: ELIRA, INC. 
10411 Clayton Road, Suite 302 
St. Louis, MO  63131 
Ph: (314) 991-7979 
Fax: (314) 991-7914 
Principal Investigator: <NAME> 
<ORGANIZATION> 
<ADDRESS 1> 
<ADDRESS 2> 
<CITY, STATE ZIP> 
Protocol Number: CD-005 
Study Device: The Elira wearable, patch system 
Date of Protocol: Version 4.0; May 3, 2019 
 
This protocol was designed and will be conducted, recorded, and reported in compliance with the 
principles of Good Clinical Practice (GCP) guidelines. These guidelines are stated in U.S. federal 
regulations. The study will be monitored according to standard clinical monitoring procedures and in 
compliance with Title 21 CFR Part 812. 
 
 
   I have read and agree to abide by the requirements of this protocol. 
 
 
 ______________________________________________________________ 
 Principal Investigator Signature 
 
 
 
 
 
Date 
 
 
The information presented in this document may be partially or wholly unpublished materials that are privileged 
or confidential. The use or disclosure of such information or materials is restricted to the persons to whom the 
information is disclosed. Applicable laws or regulations apply for disclosure in any form, including publications and 
presentations. 
 
 

3 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
TABLE OF CONTENTS 
 
Protocol Summary .............................................................................................................................. 6 
Study Title ........................................................................................................................................... 6 
Study Coordinating PIs ....................................................................................................................... 6 
Contact List ....................................................................................................................................... 16 
1. 
Introduction ................................................................................................................................ 17 
1.1 
Background ............................................................................................................................ 17 
1.2 
PENS and TENS for Weight Loss ......................................................................................... 17 
1.3 
The Hypothesized Mechanism of T6/T7 Stimulation for Appetite Suppression and Weight 
Loss 17 
2. 
Study Rationale ......................................................................................................................... 18 
2.1 
Justification for Study Given Risk/Benefit Outcome .............................................................. 19 
3. 
Device Description .................................................................................................................... 19 
4. 
Study Objectives ....................................................................................................................... 20 
5. 
Study Design ............................................................................................................................. 20 
5.1 
Dosing Schedule .................................................................................................................... 21 
5.2 
Data Collection: ..................................................................................................................... 21 
5.3 
Assignment & Blinding ........................................................................................................... 22 
6. 
Study Endpoints ........................................................................................................................ 22 
6.1 
Primary Endpoints ................................................................................................................. 22 
6.2 
Endpoint Definitions & Recording Methods ........................................................................... 23 
7. 
Study Population ....................................................................................................................... 23 
7.1 
Inclusion Criteria .................................................................................................................... 23 
7.2 
Exclusion Criteria ................................................................................................................... 24 
7.3 
Selection and Enrollment of Subjects .................................................................................... 25 
8. 
Statistical Considerations and Analysis Plan ............................................................................ 26 
8.2 
Justification of Sample Size ..................................................... Error! Bookmark not defined. 
8.3 
Retention and Handling of Missing Data ................................. Error! Bookmark not defined. 
8.4 
Subject Population for Safety and Effectiveness Analysis ..................................................... 30 
8.5 
Deviations from the statistical analysis plan .......................................................................... 30 
9. 
Study Procedures ...................................................................................................................... 30 
9.1 
Informed Consent  ................................................................................................................. 32 
9.2 
Screening Procedures ........................................................................................................... 32 
9.3 
Physical Examinations ........................................................................................................... 32 

4 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
9.4 
Body Mass Index ................................................................................................................... 32 
9.5 
Medical History and Demographics ....................................................................................... 33 
9.6 
Vital Signs .............................................................................................................................. 33 
9.7 
Medications ............................................................................................................................ 33 
9.8 
Questionnaires ....................................................................................................................... 33 
9.9 
Urine Pregnancy Tests (UPT) ................................................................................................ 33 
9.10 
Diet ........................................................................................................................................ 33 
9.11 
Electronic Daily Diary Device ................................................................................................. 33 
9.12 
Stimulation ............................................................................................................................. 33 
10. Risk Analysis ............................................................................................................................. 34 
10.1 
Risks ...................................................................................................................................... 34 
10.2 
Minimization of Risks ............................................................................................................. 35 
11. Adverse Events: Definitions & Requirements ............................................................................ 36 
11.1 
Serious Adverse Events ........................................................................................................ 36 
11.2 
Unanticipated Adverse Device Effects ................................................................................... 37 
12. Sponsor Responsibilities, Records, and Reports ...................................................................... 37 
12.1 
General Responsibilities ........................................................................................................ 37 
12.2 
Selection of Clinical Investigators Site ................................................................................... 37 
12.3 
Training of Investigator and Site Personnel ........................................................................... 37 
12.4 
Monitoring .............................................................................................................................. 37 
12.5 
Reports .................................................................................................................................. 38 
12.6 
Record Maintenance .............................................................................................................. 38 
12.7 
Regulatory Audits .................................................................................................................. 38 
12.8 
Confidentiality ........................................................................................................................ 38 
13. Investigator Responsibilities, Records, and Reports ................................................................. 38 
13.1 
General Responsibilities ........................................................................................................ 38 
13.2 
Informed Consent .................................................................................................................. 39 
13.3 
Protocol Deviations ................................................................................................................ 39 
13.4 
Reporting Requirements ........................................................................................................ 40 
13.5 
Source Documents ................................................................................................................ 40 
13.6 
Access to Source Data/Documents ....................................................................................... 40 
13.7 
Data Collection ...................................................................................................................... 40 
13.8 
On-Site Audits ........................................................................................................................ 40 
14. Site Monitoring Procedures ....................................................................................................... 40 
15. Data Quality Assurance ............................................................................................................. 41 
16. Ethical Requirements ................................................................................................................ 41 

5 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
16.1 
Declaration of Helsinki ........................................................................................................... 41 
16.2 
Subject Information and Consent .......................................................................................... 41 
16.3 
Subject Data Protection ......................................................................................................... 42 
16.4 
Reporting and Communication of Results ............................................................................. 42 
16.5 
Clinical Trial Termination ....................................................................................................... 42 
16.6 
Protocol Modifications and Deviations ................................................................................... 42 
17. Bibliography ............................................................................................................................... 43 
18. Appendices ................................................................................................................................ 44 
18.1 
Appendix 1: BMI Ranges Targeted For Men and Women Enrolled in Study 15,16 .................. 44 
18.2 
Appendix 2: TENS Unit User Manuals (Additional File Submitted Separately) ..................... 46 
18.3 
Appendix 3: PHQ-9 Questionnaire ........................................................................................ 47 
18.4 
Appendix 4: TFEQ-R18V2 17 ................................................................................................. 48 
18.5 
Appendix 5:  VAS and Daily Diary Application ....................................................................... 50 
18.6 
Appendix 6: Schedule of Events ............................................................................................ 52 
18.7 
Appendix 7: Electronic Diary Application (See Samples Screen Shots) ................................ 54 
18.8 
Appendix 8: List of Potential Drug Interactions ...................................................................... 55 
18.9 Appendix 9: End of Study Survey………………………………………………………………….50 
 
18.10 
Appendix 10: Pre-Study Survey……………………………………………………..................51 
18.11 
Miscellaneous Trial Components ....................................................................................... 61 
 
 
 
 

6 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
PROTOCOL SUMMARY 
Study Title 
ELIRA-2: Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation 
(TENS)-Assisted Weight Loss And/Or Appetite Suppression 
Study 
Coordinating 
PIs 
Shelby Sullivan, MD and Steven Edmundowicz, MD 
Study 
Rationale 
Previous studies have shown that TENS facilitates weight loss in overweight subjects. 
The therapy in these trials was delivered using an over the counter device not optimized 
for daily use.  
The present pivotal study will test the hypothesis that daily, wearable TENS is safe and 
effective for appetite suppression and weight loss therapy in overweight- to Type 1 
obese-subjects (i.e. BMI of 25 -35 kg/m2 inclusive). Ancillary endpoints include changes 
in hemoglobin A1c and blood lipids as secondary measures associated with weight 
loss.  
Name of the 
Device(s) 
Used in 
Study 
The Elira wearable patch system. 
Description 
of 
Components 
The Elira wearable patch system is an RF coupled, wearable transcutaneous electrical 
nerve stimulation (TENS) device controlled via Bluetooth by a smart phone unit running 
a custom application which directs therapy from the patch within safe limits set by a 
clinician and also includes a diary. Subjects will be supplied as well with paper diaries 
for appetite and symptoms along with an electronic scale. 
Study 
Design 
Randomized, adaptive parallel arm study. Subjects will be initially screened during a 
screening period (+/- 7 days). During this screening period, subjects will sign an 
Informed Consent Form (ICF), have their weight/height and blood pressure measured 
as part of a physical exam, take a pregnancy test (females of child bearing potential), 
get blood drawn for analysis (blood lipids, HbA1c), and complete the PHQ-9 and pre-
study survey.  Subjects will be asked to complete their first batch of diaries to set a 
baseline hunger value.  
At the end of the screening period, eligible subjects will be enrolled/randomized in the 
study and be randomized to either a treatment or control group. After enrolling, both 
control and treatment subjects will be instructed to follow a healthy diet and reduce 
calories as desired for the duration of the study and will receive training on the use of 
the electronic scale and completion of paper diaries. For the treatment group, subjects 
will be instructed on use of the Elira wearable patch system.  Photographs will be taken 
at the enrollment visit.  Following this, subjects will enter the Therapy Period for ~24-
weeks. 
At the 12 week visit, subjects will be assessed for weight loss, blood pressure, blood 
lipids, HbA1c, patient preference questionnaire and their participation will continue 
through months 4-6 for the Safety phase of the Therapy Period.  The Therapy Period 
will be considered complete (pending laboratory results, adverse events or serious 
adverse events).  Patient (treatment) photographs will also be taken at the 12 week 
visit. 

7 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
The study utilizes an adaptive approach where cohorts of enrolled/randomized subjects 
(in groups of ~25 per arm) are assessed for dose response and progression to 
achievement of primary and secondary endpoints. Frequent interim endpoint 
assessment utilizing Markov-chain Monte Carlo (MCMC) methods coupled with 
Longitudinal analyses will be utilized to determine sample sizes for future cohorts 
(assessed primarily via Normal dynamic linear modeling [NDLM]).  Long term safety of 
the device will be shown through 6 months of usage.  
Subject 
Population / 
Sample Size 
The primary endpoints are powered at a final enrollment of 75 subjects per group, for a 
total of 150 subjects, but interim analyses based on Bayesian posterior probability 
distributions with multiple imputation will be utilized to assess interim significance. 
In the event the interim analysis is not significant, up to 300 subjects may need to be 
enrolled in order to achieve final separation between groups for statistical significance. 
Thus, Elira may need to screen up to 500 subjects to account for exclusions prior to 
enrollment.  
Study 
Duration and 
Sites 
Minimum study duration for each patient will be 25 weeks. As it is expected that 
recruitment of 150 subjects will take up to 24 weeks, the overall study duration is 
anticipated to be a minimum of 37 weeks, assuming all cohorts are enrolled. The study 
will be conducted at up to 10 centers.  
Inclusion 
Criteria 
 
Subject is between 18 – 65 years of age inclusive.  
Subject has a BMI of 25-35 kg/ m2 inclusive.  
Subject has signed the informed consent form and is able to comply with study protocol 
and adhere to study visit schedule.  
Subject is able to wear and use a wearable, patch TENS system.  
Subject is able to use a touch screen hand held smart phone.  
Subject is fluent in English and can complete patient questionnaires.  
Subject is male or non-pregnant, non-lactating female, who agrees to use effective 
contraceptive methods throughout the length of the trial based on PI approval. 
Females of childbearing potential (FOCBP) must have a negative urine pregnancy test 
at screening or enrollment visit, prior to placement of ELIRA device. 
Exclusion 
Criteria 
 
Subject has any known gastrointestinal disorder that in the opinion of the PI precludes 
enrollment into the trial.  
Subject has had a prior bariatric procedure or any previous procedure on the stomach.  
Subject has any significant multisystem disease in the opinion of the PI.  
Subject has > 6.5 HbA1c.  
Subject has significant cardiac arrhythmia, ectopy, or significant cardiovascular disease.  
Subject has an existing implanted electrical stimulator (e.g., pacemaker, AICD).  
Subject is a female of child-bearing potential who is pregnant or intends to become 
pregnant during the trial period.  
Subject has current and/or a history of cancer within the past 5 years (not including 
basal cell carcinoma or cervical carcinoma in situ).  

8 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Subject has had a weight change of + 5% of his/her Total Body Weight in the 3 months 
prior to screening.  
Subject has a moderate / severe psychiatric disorder.  
Subject has a diagnosed neurological disease. 
Subject has a diagnosed eating disorder.  
Subject has a skin disorder affecting the thoracic dermatomes  
Subject has active or /has ever had shingles in the abdomen area. 
Subject has abdominal surgery or other scars which may interfere with stimulation in the 
opinion of the PI. 
Subject is currently enrolled in other, potentially confounding research.  
Subject has known allergic reaction to materials in the electrodes and/or is otherwise 
unable to tolerate stimulation with the wearable TENS system.  This includes known 
allergies to latex, nickel and/or hydrogels. 
Subject has a history of sensitive skin, including eczema, wheel-and-flare or other skin 
irritation, per PI discretion. 
Subject is actively participating or unwilling to discontinue participation in another 
weight loss program.  Subjects may not enroll in paid or unpaid programs that involve 
in-person or online apps or coaching, beginning new fitness regimens or utilizing meal 
planning or paid nutritional coaching during the course of the ELIRA study. 
Subject is taking weight loss control medications including but not limited to OTC 
medications, Metformin, and Belviq. (See Appendix 8) 
Subject is planning any major medical treatments or surgeries that could cause weight 
loss. 
Subject is unable to take anti-nausea medications planned for the study. 
Inability to walk at least 0.8 kilometers per day (10 minutes of continuous walking). 
Current smoker or user of nicotine product or smoking cessation within 1 year of the 
screening date. 
History of treatment for or current abuse of drugs or alcohol. 
A score of ≥10 on the Patient Health Questionnaire 9 (PHQ-9), demonstrating moderate 
depression. 
Any subject that the investigator considers inappropriate for the study for medical 
reasons.  
Subject has a history of moderate/severe migraines or other severe headache disorders 
requiring the treatment of Topiramate. 
Subject is on drug therapy which may alter antral motility or appetite, per PI discretion 
(Appendix 8). 
Study 
Outline 
 
 
 

9 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
 
Dosing 
Regime 
Treatment subjects will be trained in rotation of the patch electrodes every 24h such 
that it is applied to varying locations on the T6/T7 dermatome. Each treatment subject 
will receive two treatments of up to 40 mA of sustained current stimulation for 30 
minutes each delivered approximately 30 minutes prior to meal times (based on 
established times set in the smartphone application), not to exceed 75min daily without 
express consent of PI. Based on tolerance of the therapy, a subject may decrease 
his/her dose by dropping one of the therapy sessions after receiving approval from a 
clinical coordinator and/or PI. In addition, subjects who do not experience sufficient 
appetite suppression may also add up to three 5-minute “on-demand” sessions at 20mA 
between regular doses after receiving approval from a clinical coordinator and/or PI. 
The nominal stimulation dose per day for any subject will thus be 1200mA (60 minutes 
at 20 mA) while the maximum dose for any given subject will be 3000 mA (75 minutes 
at 40 mA). 
Visit 
Schedule 
Screening/Baseline Visit 0 (-1 week; +7 days) – Obtain Informed Consent prior to any 
study procedures. Confirm subject has met all inclusion criteria and no exclusion 
criteria. History & Physical including height & weight, diet history, baseline clinical 
parameters, provide laboratory requisition, urine pregnancy test for women of 
childbearing potential (FOCBP), and questionnaires.  Subjects will be given their first 
batch of paper diaries to complete to establish a baseline hunger.  
Enrollment/Randomization Visit 1 (Day 0;1; all durations are + 7 days) – Confirm 
subject continues to meet all inclusion criteria and no exclusion criteria. Assessment of 
T6/T7 dermatomes, clinical parameters, BP, weight, perform urine pregnancy test for 
FOCBP if not done at screening, administer TFEQ-R18V2 Questionnaire, assess for 
adverse events and changes to concomitant medications.  Subjects will be randomized 
based on the blocked randomization algorithm. 

10 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Treatment and Control subjects will be instructed to follow a healthy diet and reduce 
calories, if possible, throughout the study and given the Diet Resources sheet in 
Appendix 18.11.  They will also receive an electronic scale with instructions on use will 
be provided, and 8 copies of a daily paper diary will be provided. Subjects will be 
instructed to return with their paper diary(ies) at the next scheduled visit. 
Only the treatment subjects will receive a handheld smartphone with the custom 
application and an Elira wearable patch system. It is recommended for treatment 
subjects to utilize an TENS Clean-Cote Skin Wipes and/or alcohol prep pad wipe to 
maintain a clean application area for the treatment. Treatment subjects will also receive 
Cetaphil Moisturizing Lotion to be used nightly after removing the ELIRA patch and 
applied throughout the abdomen area. Subject will be instructed to notify site 
immediately if any irritation occurs. Treatment subjects will stimulate under the 
supervision of the investigator or coordinator for 30 minutes prior to being discharged 
with the device. Treatment subjects will be assessed for toleration of the stimulation to 
further evaluate dose adjustment. Treatment subjects will be discharged with the Elira 
wearable patch system & Smartphone App and instructions on use. Treatment subjects 
will be instructed to return with the Elira wearable patch system and smartphone app at 
their next scheduled visit. Completion of patient questionnaires (All subjects).  A below 
the neck photograph of the Treatment subjects will be taken at the enrollment visit, with 
the subjects dressed in biker shorts and sports bra (F) or athletic shorts (M). 
 
Therapy Phase Visits 2, 3, 4, 5, 6, and 7 (week 1, 4, 8, 12, 16, and 20,  respectively; 
+ 7 days) – Treatment and Control subjects will be assessed for adverse events, 
changes to concomitant medications and commitment to exclusion criteria. Obtain BP 
and weight. Administer the TFEQ-R18V2 Questionnaire. Collect and review paper 
diaries, dispense new paper diaries and review instructions for weekly completion. All 
subjects will be encouraged to follow a healthy low-calorie diet throughout the study. At 
week 1, subjects will return their first week’s worth of paper diaries.  At week 4, subjects 
will be given a new set of 8 paper diaries and instructed to complete paper diaries for 
each week beginning the day after the visit.  At week 8, they will return their “week 4 
diaries” and be given the next set of 8 paper diaries to be completed each week,…,until 
the final week of using the device (week 23-24). 
Treatment subjects will be assessed for any adverse device effects (ADE), T6/T7 
dermatome assessment, review and download of diary data, and stimulation adjustment 
(if needed).  If skin irritation is present, PI will classify as Mild, Moderate or Severe and 
confirm system compliance (wipes, lotion, patch rotation, etc.).  Mild irritation may 
require up to 3 days without stimulation.  Moderate irritation may require up to 2 weeks 
without stimulation.  Severe irritation may require medical attention and study 
termination.  PI or designee will assess when irritation is present and review for 
resolution. Treatment subjects will be discharged with the smartphone application and 
the Elira wearable patch system and instructions on use. Treatment subjects will be 
instructed to return with the Elira wearable patch system and smartphone app at their 
next scheduled visit.  Treatment subjects may be contacted by PI or clinical coordinator 
periodically through the trial to address any questions or concerns related to device 
function. 
End of Study Visit 8 (week 24; + 7 days) – Treatment & Control subjects will be 
assessed for adverse events, changes to concomitant medications and commitment to 
exclusion criteria. Physical including weight, requisition for laboratory tests, blood 

11 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
pressure, labs, and urine pregnancy test for FOCBP, and completion of questionnaires 
(– PHQ9, TFEQ-R18V2, and Patient Preference Survey). Collect, and review paper 
diaries. This visit may be rescheduled if the paper diaries were not completed the week 
prior.   
Treatment Group Only- Complete End of Study Questionnaires- subjects will return the 
Elira wearable patch system and the smartphone application. Treatment subjects will be 
assessed for ADEs and have their T6/T7 dermatome area examined.  Treatment 
subjects will be photographed (below the neck) in similar attire to their initial visit for 
weight loss reference.   
Study 
Endpoints 
 
Primary Safety/Tolerability Endpoint:  
Safety/Tolerability will be assessed by the non-inferiority of incidence of serious adverse 
events (SAEs), unanticipated SAESs(USAEs), device-related SAEs (DSAEs) and 
Unanticipated Device Related SAEs (UDAEs) that are associated with the TENS 
therapy throughout the stimulation and the follow-up period versus historical control 
(compared with other TENS systems). 
Safety variables will be tabulated and presented for all subjects including enrolled, but 
discontinued, subjects. Number of subjects undergoing active stimulation and any 
reasons for discontinuation of study treatment will be tabulated. 
Safety/Tolerability will be assessed through 6 months of therapy. 
Primary Effectiveness Endpoint: 
The primary efficacy endpoint is the percent reduction in appetite suppression as 
measured by percent change in appetite scores at the end of 3 months of the Therapy 
period compared to Baseline between Treatment and Control. 
A co-primary endpoint will be total body weight loss (%TBWL), measured as End 
Weight – Initial Weight divided by Initial Weight, multiplied by 100, at the end of 3 
months of the Therapy period compared to Baseline between Treatment and Control.  
Secondary Effectiveness Endpoints:  
Number of subjects reporting >5% total body weight loss at the end of 3 months of the 
Therapy compared to Baseline between Treatment and Control 
Blood pressure, blood lipids, and HbA1c at the end of 3 months of the Therapy 
compared to Baseline between Treatment and Control groups. 
% changes in BMI at the end of Therapy compared to Baseline between Treatment and 
Control groups 
Ancillary Endpoints: 
Cross validation between smartphone app hunger scales and paper VAS diaries 
collected at the same times. 
Changes between the following values: 
Ease of use/prevalence of use errors associated with the patch unit and dietary 
application during initial training. 
Subject preference scores at the end of Therapy compared to Baseline between 
Treatment and Control groups. 

12 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Statistical 
Analysis 
 
Statistical Analysis Plan, 2019MAY31 
 
ELIRA -2 Trial: Safety and Effectiveness of Transcutaneous Electrical Nerve 
Stimulation (TENS)-Assisted Weight Loss and/or Appetite Suppression 
Protocol Number: CD-005, Original Date:2018MAY08, V4.1, Revised 
Date:2018AUG14 
 
Signature Page 
 
 
Author: Michelle Secic  ___________________________    Date ________________ 
 
Approver: ______________________________________    Date ________________ 
 
Approver: ______________________________________    Date ________________ 
 
 
STATISTICAL CONSIDERATIONS AND ANALYSIS PLAN 
 
General Methods 
Categorical variables will be summarized by number and percent.  Continuous variables will be 
summarized by total number (N), mean, standard deviation (SD), median, minimum and 
maximum.  Ninety-five percent, 2-sided confidence intervals will be reported, as appropriate. 
As this was a randomized trial, the groups are expected to be balanced on demographic and 
baseline characteristics.  No formal testing for this is planned.   
Planned analyses and summaries for the primary safety endpoint, co-primary efficacy 
endpoints, secondary efficacy endpoints and exploratory efficacy endpoints are detailed below. 
Analysis Populations  
The intent to treat (ITT) analysis population is defined as all subjects who were enrolled.   
The modified intent to treat (mITT) analysis population is defined as all subjects who initiated 
therapy (i.e., initiated their first Treatment Period Visit) and had data through week 12.  All 
safety and effectiveness analyses will be completed on the mITT analysis population. 
The per protocol (PP) analysis population is defined as all subjects who met all 
inclusion/exclusion criteria, completed all visits in the study without any major protocol 
deviations.  All effectiveness analyses will be completed on the PP analysis population. 

13 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Safety Analyses 
The primary safety endpoint is defined as the proportion of subjects free of TENS-related 
serious adverse events and adverse device effects through the therapy phase, safety success 
rate.  The success rates will be compared between groups using chi-square test or Fisher’s 
exact test, as appropriate. 
Efficacy Analyses 
Co-Primary Efficacy Analyses 
The percent change from baseline in the co-primary endpoints, appetite suppression scores, at 
the end of 3 months will be analyzed with analysis of covariance (ANCOVA), with a factor for 
group treatment and a baseline covariate for the appetite score at baseline.  Specifically, the 
appetite suppression scores include four individual components (satisfied, full, hungry, eat 
from Table 1 of the diaries), each ranging from 0 to 100: 
- 
How satisfied do you feel? 0=I am not hungry at all, 100=I have never been more 
hungry 
- 
How full do you feel? 0=I am completely empty, 100=I cannot eat another bite 
- 
How hungry do you feel? 0=Not full at all, 100=Totally full 
- 
How much do you think you can eat? 0=Nothing at all, 100=A lot 
These scores are captured in a diary once a week with 8 time points.  The weeks are captured 
as week 0 through week 24.  The time points at each week include: 
- 
30 minutes before breakfast 
- 
30 minutes after breakfast 
- 
60 minutes after breakfast 
- 
90 minutes after breakfast 
- 
Pre-lunch 
- 
Midafternoon 
- 
30 minutes before dinner 
- 
Bedtime 
For each of the four appetite suppression variables, the 8 time points at week zero will be 
average at week 0 for the baseline score (baseline), and the 8 time points at week 12 will be 
averaged at week 12 for the 3-month score (3month).  Then the primary endpoint of the 
percentage change at 3 months will be calculated as: 100% x (3month – Baseline)/Baseline 
Next, the percent change from baseline in the co-primary endpoint, %TBWL, at the end of 3 
months will be analyzed with analysis of covariance (ANCOVA), with a factor for group 
treatment and a baseline covariate for the %TBWL at baseline. 
Note that the ANCOVA analyses with last observation carried forward (LOCF) imputation for 
missing data on the mITT population for the co-primary endpoints are the main analyses for the 
study and if either %TBWL or any of the 4 appetite suppression variables result in statistical 
significance, then the study will be deemed a success.   
Secondary Efficacy Analyses 

14 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Area under the curve (AUC) statistics will be provided by group on each of the appetite 
suppression scores to assess the impact of the device on appetite at three months. AUC will be 
calculated using the trapezoidal method for total AUC across 3 months. 
To further understand the time points and weekly diary entries on appetite suppression, all 
time points and weekly entries will be analyzed in a repeated measures analysis of variance 
(RMANOVA) for each of the four appetite suppression endpoints separately.  The RMANOVA 
will not use percentage changes but will use the actual appetite suppression scores with a 
factor for group treatment, time (week and time point), as well as the interaction factor 
between time and treatment. 
The occurrence rate for subjects experiencing >5% TBWL at the end of 3 months will be 
compared between groups using chi-square test or Fisher’s exact test, as appropriate. 
Blood pressure, blood lipids, and HbA1c at the end of 3 months of the Therapy compared to 
Baseline between groups using t-tests or Wilcoxon rank sum tests, as appropriate. 
The percent change from baseline in BMI at the end of 3 months of the Therapy compared to 
Baseline between groups using t-tests or Wilcoxon rank sum tests, as appropriate. 
Exploratory Efficacy Summaries 
Summary statistics will be provided by visit and by group for the other time points (besides the 
3 month time point) for percent change from baseline in appetite suppression scores, %TBWL, 
occurrence rate for >5% TBWL, blood pressure, blood lipids, and HBA1c.  In addition, summary 
statistics will be provided by visit and by group for ease of use, prevalence of use errors 
associated with patch unit and dietary application, and preference scores. 
Justification of Sample Size 
As per the protocol, the calculation sample size for the study is based on conservative 
imputation of results from other studies on weight loss including the use of TENS for weight 
loss.  The degree of coaching/dietary support throughout the present study is moderate 
intensity lifestyle/weight coaching.  The sample size modeling assumes an average of 3.5% 
TBWL in Control Subjects using diet and exercise alone.  The estimated weight loss in 
Treatment Subjects is modeled from preliminary data on T6/T7 dermatomal TENS when used 
for weight loss: 6% TBWL.  The variance of the responses in the study (i.e. Standard Deviation) 
was modeled at +/- 5% TBWL.  This value was taken from previous dermatomal TENS weight 
loss study results.  The model assumes a 30% drop out rate across groups and an 80% powered 
endpoint using an adaptive p spending model wherein interim posterior probability 
assessments are allowed after enrolling proscribe cohorts of not less than 67% of subjects.  The 
alpha penalty will be minimized per interim by assessing the relationship between stimulation 
(i.e. dose) and weight loss using Normalized Linear Dynamic Modeling (NLDM) to determine 
overall sample size projected (i.e. futility) rather than assessing the primary hypothesis per se.  
Monotonicity will not be assumed in this analysis.  This modeling provides an estimate of 80 
subjects per group, for a total study size of 160 subjects.  However, the protocol allows for 
enrollment of additional subjects should the interim model project under powering of the 
primary endpoint. 
Handling of Missing Data 
Every effort will be made to collect all data at each time point in the study.  The PI and the 
Clinical Data Monitor will minimize the amount of missing data by appropriate management of 

15 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
the prospective clinical trial, proper screening of subjects, and training of clinicians.  If a subject 
misses a dietary entry in to either the paper or electronic diary, a look back entry for that value 
is allowed provide for the week preceding the event.  Outside this window, data will be 
considered missing.  All partial data available for subjects who drop out during the course of 
the study will be included. 
Missing data will only be imputed for the co-primary endpoints. The LOCF method will be 
utilized at the 3 month time point for the two co-primary endpoints of percent change from 
baseline in appetite suppression scores and %TBWL.  The ANCOVA analysis with LOCF on the 
mITT population for the co-primary endpoints were planned for the main analyses for the study 
to determine study success.  Note, however, by definition, the mITT population may not need 
LOCF as only those with a week 12 visit will be included in the mITT population.  A patient, 
however, may have had a week 12 visit but have missing data on some or all co-primary 
endpoints, in which case LOCF methods will be used. 
To assess the potential effect of missing data on the co-primary effectiveness endpoints, a 
tipping point analysis will be computed for each co-primary endpoint on the mITT population.  
If none of the 5 co-primary endpoints are missing at week 12, the tipping point analysis will be 
a moot point and will not be conducted.  A tipping point analysis involves imputing each 
missing data point, one-at-a-time until the study conclusion is tipped in the other direction (i.e., 
from statistically significant to non-statistically significant or vice versa, from non-statistically 
significant to statistically significant).   
Risk/Benefit 
Analysis 
If shown to be safe and effective, the therapy could eventually provide overweight/ 
moderately obese subjects a low risk option for appetite suppression and weight loss 
beyond diet and lifestyle modification alone. 
The potential adverse events and adverse device effects and risks associated with this 
study and the use of the patch System are identical to those normally associated with 
standard TENS system used for pain control and similar indications.  
 
 
 
 
 
 

16 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
CONTACT LIST 
Study Sponsor 
ELIRA, Inc. 
Coordinating Principal Investigators 
 
Shelby Sullivan, MD and Steven 
Edmundowicz, MD 
Study Monitor 
 
Stephanie Amlung, PhD 
Data Management 
Danielle Gherardini, RN BSN 
Statistical Analysis 
Ian Welsford, PhD 
Data Safety Monitoring Board 
Virender K. Sharma, MD 
 
 
 

17 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
1. 
INTRODUCTION 
1.1 
BACKGROUND 
According to the Centers for Disease Control (CDC) up to 35% of adults over the age of 20 are 
obese, meaning they have a body mass index (BMI) of over 30 kg/m2 while up to 69% of 
similarly aged adults are overweight, meaning they have a BMI of 25-30 kg/ m2 (1; Appendix 1). 
Individuals who are overweight or obese are at high risk for adverse impacts to quality of life 
(QOL) factors including general health (2), pain (3) and psychosocial status (4). However, losing 
weight via calorie restriction dieting is notoriously difficult for such individuals (2). Sustained loss 
of even 5-10% of weight is uncommon with most dieters (2, 3) with most regaining nearly half of 
the lost weight after one year (4). While the precise physiological, sociological and genetic 
factors associated with weight gain and weight loss remain an area of intense investigation, 
what is becoming clear is that sustained weight loss requires long term calorie intake reduction 
(2), which, in turn, appears to require, among other factors, appetite control (2, 4). The purpose of 
the present non-significant risk (NSR) study is to investigate the effect of transcutaneous 
electrical nerve stimulation (TENS) on weight loss in overweight-to moderately (i.e. Type 1) 
obese individuals (i.e. BMI of 25 to 35 kg/ m2 inclusive 15,16; Appendix 1) with a long-term goal of 
determining if such an approach may be of benefit in assisting such individuals in achieving their 
weight loss goals.  
1.2 
PENS AND TENS FOR WEIGHT LOSS  
Transcutaneous electrical nerve stimulation (TENS) involving the delivery of electrical current to 
subcutaneous nerve branches via an electrode placed on the skin surface is a well-established 
treatment modality for muscle pain, muscle atrophy and spasms as well as for pain associated 
with a variety of conditions including diabetic neuropathy. More recently this modality has been 
shown to be effective in treating certain symptoms associated with migraine headaches by 
delivering electrical stimulation to branches of the trigeminal nerve (8). A related therapy, 
Percutaneous Electrical Nerve Stimulation (PENS), in which electrode is inserted into the 
epidermis, is now in general medical usage for the treatment of urinary incontinence, fecal 
incontinence, and back pain (5-8). 
The clinical evidence for a PENS effect on appetite and weight loss is provided by Ruiz-Tovar’s 
study which demonstrated significant weight loss for PENS stimulation of dermatome T6 (the 
area of skin supplied by cutaneous branches of a single cranial or spinal nerve) via appetite 
suppression in a European sham control study of 105 subjects (9). Similar preliminary clinical 
results utilizing TENS have been reported in appetite control and subsequent weight loss by Dr. 
John Faul, a Stanford University researcher, who was granted a method patent (Transcutaneous 
Electrical Nerve Stimulator for Appetite Control) for his invention that uses TENS to stimulate the 
thoracic spine area at T6–T10. Each of these studies utilized obese subjects and provided 
stimulation only during in-clinic supervised sessions. The present study is designed to extend 
these preliminary studies by utilizing TENS in overweight-to Type 1 obese-subjects (i.e. BMI of 
between 25 and 35 kg/ m2 inclusive 15,16) stimulating in an outpatient/at home setting using a 
wearable, patch TENS system. 
1.3 
THE HYPOTHESIZED MECHANISM OF T6/T7 STIMULATION FOR APPETITE SUPPRESSION AND 
WEIGHT LOSS 
The effect of PENS, and presumably, TENS, has been widely demonstrated by posterior tibial 
nerve neuro-stimulation in treating urinary and fecal incontinence, creating a somato-autonomic 
reflex (10,11; Figure 1). The definition of a somato-autonomic reflex is a reflex elicited by 
stimulation of somatic tissue (strictly speaking, tissue of the musculoskeletal system and the 
dermis of the skin), and manifesting as an alteration of the autonomic nervous  

18 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
Figure 1: Somato-Autonomic Reflex Arc  
system function (Figure 1). Altered autonomic nervous system functions may lead to changes in 
the function of dependent organs (like the stomach and other gastrointestinal organs), a 
situation sometimes referred to as a Somato-visceral reflex. To the PI’s knowledge, the study 
cited by Ruiz-Tovar is the first to report using PENS of dermatome T6 to reduce appetite and, 
consequently, obtain a clinically-significant weight loss (9). It is likely that the effect is produced 
by the creation of a Somato-autonomic reflex in similar fashion to percutaneous electrical 
stimulation of the posterior tibial nerve in treating incontinence, but in this case suppressing 
appetite (10).  
As supported by Dr. Faul’s preliminary results (9), it is likely that similar results to PENS can be 
obtained using TENS to stimulate the same region, given the shallow 2 to 4 milimeter depth of 
sensory afferents throughout the target dermatome. Chen reported that electric gastric 
stimulation with a gastric pacemaker may affect the central nervous system by segregating 
hormones in the stomach and regulating satiety and/or appetite, with ghrelin being particularly 
involved in this mechanism (11). As shown by Ruiz-Tovar’s study, the electric stimulation’s main 
effect is appetite reduction. This study consisted of 105 subjects divided into 3 groups. Group 1 
included 45 subjects who underwent dermatome T6 stimulation and maintained a 1,200 calorie 
diet and who were scheduled for bariatric surgery. These subjects had BMIs of greater than 40 
or greater than 35 with co-morbidities. Group 2 included 45 subjects that maintained a 1,200 
calorie diet only and who were scheduled for bariatric surgery. These subjects also had BMIs of 
greater than 40 or greater than 35 with co-morbidities. Group 3 included 15 subjects with a BMI 
greater than 30 who received sham stimulation (at the ankle) and who maintained a 1,200 
calorie diet. Group 1, the treatment arm, evidenced dietary compliance in excess of 90% and 
achieved a significant weight loss success (equal to or greater than 5 kilograms (11 pounds) in 
76.7% of subjects, as compared to Groups 2 and 3 where weight loss success was less than 
6.7% and 0.0%, respectively. No complications were observed associated with the technique.  
It thus appears likely that, through safely stimulating T6/T7 via TENS, a Somato-visceral reflex 
arc will be activated which will suppress appetite and support eventual weight loss in overweight 
and obese subjects.  
2. 
STUDY RATIONALE 
The purpose of the present study is to determine the safety and effectiveness of stimulation via 
a wearable patch TENS system of the T6/T7 dermatome on appetite suppression in adult (18 to 

19 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
65 years of age inclusive), overweight/obese subjects (i.e. a BMI of 25 to 35 kg/m2 inclusive15, 
16; Appendix 1) who desire to lose weight. The study will seek thus to extend existing data on 
the use of dermatomal stimulation on obese and morbidly obese patient to subjects who are 
overweight/obese (i.e. a BMI of 25 to 35 kg/m2 15, 16; Appendix 1).  
2.1 
JUSTIFICATION FOR STUDY GIVEN RISK/BENEFIT OUTCOME 
Up to 35% of adults over the age of 20 in the United States are overweight. Being overweight 
places individuals at higher risk for a number of what are termed metabolic disorders including 
diabetes mellitus. This risk association is thought to be the reason for the high health care costs 
associated with overweight and obesity. While diet and exercise do show efficacy in a 
substantial subset of subjects, long term weight control is difficult to achieve for the vast majority 
of overweight individuals. The physiological and psycho-social reasons for this are not well 
characterized and likely highly complex, but a key component of this challenge is associated 
with appetite control. The present study seeks to determine if a method of appetite control 
utilizing T6/T7 dermatome stimulation in obese individuals can be utilized to the broader 
overweight population. The study utilizes non-invasive TENS stimulation within the range of the 
energy delivery well known to be safe for at-home use for nerve and muscle pain. Subjects will 
be informed of all potential side effects related to stimulation prior to enrollment and, throughout 
the study, subjects will be monitored and allowed to decrease or discontinue stimulus if any such 
side effects are deemed to be intolerable for participants. 
In addition, since appetite and weight loss can be affected by a variety of physiological and 
psychosocial factors (12,13, 15, 17), the change in appetite will be measured weekly using a 
validated tool, the Visual Analog Scale (VAS14; See Appendix 3) and also assessed at baseline 
at the end of the study via administration of the Three Factor Eating Questionnaire R-18 V2 
(TFEQ-R1V217, 18). Please note that while the VAS was first developed for pain, it has been 
validated for weight loss/appetite applications (14) while the TFEQ-R18V2 has specifically been 
validated in weight loss applications (17, 18). The present study is not intended to be a formal 
validation of the assessment tool’s applicability to the population targeted by the present study 
per se; it is intended simply as an assessment of potential changes in such parameters 
correlated with delivery of therapy during the study. Thus, the use of the tool as presented is 
considered scientifically valid. 
Thus, the non-significant risk of the study is more than balanced by the potential societal benefit 
of the development of this novel, non-invasive appetite control method.  
3. 
DEVICE DESCRIPTION 
The TENS System consists of: 
TENS Unit (Appendix 2) 
ELIRA wearable Patch 
Electronic Diary tool 
(Appendix 5) 
Diary/dietary application running on and Android Smart-
phone: 
4.5” 720p HD TFT display 
Size (LWH): 2.6 inches, 0.46 inches, 5.1 inches 
Weight: 4.96 ounces 
Device Accessories 
Extra packs ELIRA electrodes 
Device/Phone Chargers 
Electronic Scale 
Plastic Phone Cover and System Pack 

20 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Other study accessories  
TENS Clean-Cote Skin Wipes or ALCOHOL prep pads/wipes 
Cetaphil Moisturizing Lotion (16oz), and Paper diaries  
 
4. 
STUDY OBJECTIVES 
The objectives of this study are to demonstrate safety and effectiveness of a wearable patch TENS 
system (Appendix 2) in driving weight loss and appetite suppression when coupled with an integrated 
weight loss reduction strategy. The study is designed to demonstrate that TENS stimulation sufficient 
to drive weight loss and appetite suppression is safe and tolerable when compared to standard of 
care, and that adverse events/adverse device effects are similar to other TENS device use cases.  
5. 
STUDY DESIGN 
Randomized, adaptive parallel arm study. Subjects will be initially screened during a screening period 
(1 week, ±7 days; Figure 2). During this screening period, prior to study procedures being performed, 
subjects will sign an informed consent form. Then they will have their weight and blood pressure 
measured, FOCBP will have a pregnancy test, get blood drawn for analysis (blood lipids, HbA1c), and 
complete patient preference questionnaires. At the end of the screening/baseline period, eligible 
subjects will be offered the chance to enroll in the study. After enrolling, subjects will be randomized to 
treatment or control groups.  
The Treatment group will be instructed to follow a healthy diet that they will follow for the duration of 
the study and will receive training on the use of the paper diaries, electronic scale, smartphone app 
and the Elira wearable patch system. All treatment subjects will be required to stimulate in the office 
for up to 30minutes to confirm sufficient system training and to acknowledge understanding 
stimulation settings.  A below neck photograph will be taken of the treatment group in requested attire 
(i.e. biker shorts and sports bra for women, biker shorts for men).  Following this, subjects will enter 
the Therapy Period, for a ~24-week duration.  Treatment subjects may be contacted by PI or clinical 
coordinator to address any questions related to device functionality or compliance.  Device usage will 
be monitored throughout therapy phase to ensure proper functionality and subject safety. 
The Control group will be instructed to follow a healthy diet that they will follow for the duration of the 
study and will receive training on the use of the weekly paper diary and electronic scale. The Control 
group will not receive the electronic smartphone app or the Elira wearable patch system/components. 
At the end of the 3 months of the Therapy Period, all subjects will be assessed for weight loss, blood 
pressure, blood lipids, HbA1c, and will continue to participate through months 4-6 to confirm the long 
term safety of the device prior to being terminated from the study.  A below neck photograph will also 
be taken at the 12 week visit.  
The Kaplan Meier estimator will be utilized to compare decrease in %Total Body Weight Loss 
(&TBWL) and appetite scores between treatment and control subjects.  Maximum likelihood statistics 
will be utilized to correct for censoring.  Z statistics will be calculated to ensure lack of skewness or 
curtosis and square root arc sine transformations will be undertaken on the data if required prior to 
analysis. 
 
 
  
 
 

21 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Figure 2: Study Outline 
 
5.1 
DOSING SCHEDULE 
All Treatment Subjects will be trained in required rotation of the patch electrodes every 24h such 
that it is applied to varying locations on the T6/T7 dermatome. Each active therapy subject will 
receive up to 40 mA sustained current of stimulation for up to 30 minutes delivered within 
approximately 30min of meal time (pre-meal breakfast and dinner), not to exceed 75 min daily 
(including up to 3-5min rescue sessions).  Based on tolerance of the therapy, a subject may 
decrease his or her dose by dropping one of the pre-meal sessions after receiving approval from 
a clinical coordinator and/or PI. Subjects who do not experience sufficient appetite suppression 
may also add up to 3 between meal 5min rescue sessions delivered after receiving approval 
from a clinical coordinator and/or PI. The nominal stimulation dose per day for any subject will 
thus be 1200 mA (60 minutes at 20 mA) while the maximum dose for any given subject will be 
3900 mA (90 minutes at 40 mA and rescue sessions). 
During the therapy period, Treatment Subjects will undergo initial assessments to ensure they 
are familiar with the device, the daily electronic diary, weekly paper diary, and diet options. All 
subjects (Treatment and Control) will be required to undergo follow-up assessments at least 
once per every 4 weeks during the study. Additional unscheduled visits per subject will be 
permitted during the study to address issues related to subject safety. PI and/or clinical 
coordinator will oversee any adjustments to treatment dosing or stimulation parameters and may 
contact treatment subjects to address any concerns regarding device functionality. 
5.2 
DATA COLLECTION: 
All subjects will be asked to keep a VAS paper diary (hunger, appetite, weight and diet) in which 
they will record such values weekly. Subjects will record their diary variables. For treatment 

22 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
subjects, any adjustments to stimulation session schedule will be recorded within the electronic 
diary and by clinical coordinators. 
5.3 
ASSIGNMENT & BLINDING 
Subjects meeting the Inclusion and Exclusion criteria will be enrolled and randomized into either 
Treatment or Control groups. The randomization algorithm will be blocked to account for site 
bias and to ensure counterbalance across sites. As this is an open label study, there will be no 
consideration for blinding.  
6. 
STUDY ENDPOINTS 
6.1 
PRIMARY ENDPOINTS 
6.1.1 Primary Safety/ Tolerability Endpoints: 
• 
Safety/Tolerability will be assessed by the non-inferiority of incidence of serious 
adverse events (SAEs), unanticipated SAES (USAEs), device-related SAEs 
(DSAEs) and Unanticipated Device Related SAEs (UDAEs) that are associated 
with the TENS therapy throughout the therapy/treatment period versus 
historical control. 
• 
Safety variables will be tabulated and presented for all subjects including 
enrolled, but discontinued, subjects. Number of subjects undergoing TENS and 
any reasons for discontinuation of study treatment will be tabulated. 
• 
Safety variables will be collected over a 6 month duration. 
6.1.2 Primary Effectiveness Endpoint: 
The primary efficacy endpoint is the percent reduction in appetite suppression 
as measured by percent change in appetite scores at the end of 3 months of 
the Therapy period compared to Baseline between Treatment and Control. 
A co-primary endpoint will be total body weight loss (%TBWL), measured as 
End Weight – Initial Weight divided by Initial Weight, multiplied by 100, at the 
end of 3 months of the Therapy period compared to Baseline between 
Treatment and Control.  
6.1.3 Secondary Effectiveness Endpoints:  
• 
Number of subjects reporting >5% total body weight loss at the end of 3 months 
of the Therapy period as compared to Baseline between Treatment and Control 
• 
Blood pressure, blood lipids, and HbA1c at the end of 3 months of the Therapy 
Period as compared to Baseline between Treatment and Control groups. 
• 
% changes in BMI at the end of 3 months of the Therapy Period compared to 
Baseline between Treatment and Control groups. 
6.1.4 Ancillary Endpoints: 
• 
Cross validation between smartphone app hunger scales and paper VAS diaries 
collected at the same times. 
Changes between the following values: 
• 
Ease of use/prevalence of use errors associated with the patch unit and dietary 
application during initial training. 
• 
Subject preference scores at the end of Therapy Period compared to Baseline 
between Treatment and Control groups. 

23 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
6.2 
ENDPOINT DEFINITIONS & RECORDING METHODS 
Endpoint data in hunger, appetite, and dietary compliance are obtained from subject reported 
assessments (Appendix 4, 5). That is, the measurement of success is based on the subject’s 
report of the parameter using validated tools where available.  
Primary source data will be paper based, with each subject receiving diary worksheets to record 
responses. Treatment subjects will also be assigned an Android Smart Phone onto which has 
been loaded a copy of custom dietary application (Appendix 5). Subjects will be trained on the 
use of these tools and assessed for accurate use prior to taking them home. To ensure data 
privacy, the network interface card (i.e. SIM card) for the phone will be removed such that data 
can only be downloaded via a direct USB link. 
7. 
STUDY POPULATION 
7.1 
INCLUSION CRITERIA 
7.1.1 Subject is between 18 – 65 years of age inclusive.  
7.1.2 Subject has a BMI of 25-35 kg/ m2 inclusive.  
7.1.3 Subject has signed the informed consent form and is able to comply with 
study protocol and adhere to study visit schedule.  
7.1.4 Subject is able to wear and use a wearable, patch TENS system.  
7.1.5 Subject is able to use a touch screen hand held smart phone.  
7.1.6 Subject is fluent in English and can complete questionnaires. 
7.1.7 Females of childbearing potential (FOCBP) must have a negative urine 
pregnancy test at screening or enrollment visit, prior to placement of ELIRA 
device. 
7.1.8 Subject is male or non-pregnant, non-lactating female, who agrees to use 
effective contraceptive methods throughout the length of the trial based on PI 
approval. 
 
 

24 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
7.2 
EXCLUSION CRITERIA 
7.2.1 Subject has any known gastrointestinal disorder that in the opinion of the PI 
precludes enrollment into the trial.  
7.2.2 Subject has had a prior bariatric procedure or any previous procedure on the 
stomach.  
7.2.3 Subject has any significant multisystem disease in the opinion of the PI.  
7.2.4 Subject has > 6.5 HbA1c.  
7.2.5 Subject has significant cardiac arrhythmia, ectopy, or significant 
cardiovascular disease.  
7.2.6 Subject has an existing implanted electrical stimulator (e.g., pacemaker, 
AICD).  
7.2.7 Subject is a female of child-bearing potential who is pregnant or intends to 
become pregnant during the trial period.  
7.2.8 Subject has current and/or a history of cancer within the past 5 years (not 
including basal cell carcinoma or cervical carcinoma in situ).  
7.2.9 Subject has had a weight change of + 5% of his/her Total Body Weight in the 
3 months prior to screening.  
7.2.10 Subject has a moderate / severe psychiatric disorder.  
7.2.11 Subject has a diagnosed neurological disease. 
7.2.12 Subject has a diagnosed eating disorder.  
7.2.13 Subject has a skin disorder affecting the thoracic dermatomes. 
7.2.14 Subject has active or /has ever had shingles in the abdominal area.  
7.2.15 Subject has abdominal surgery or other scars which may interfere with TENS 
stimulation in the opinion of the PI. 
7.2.16 Subject is currently enrolled in other potentially confounding research.  
7.2.17 Subject has known allergic reaction to materials in the TENS electrodes 
and/or is otherwise unable to tolerate stimulation with the wearable TENS 
system.  This includes known allergies to latex, nickel and/or hydrogels. 
 

25 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
7.2.18 Subject has a history of sensitive skin, including eczema wheel-and-flare or 
other skin irritation, per PI discretion. 
7.2.19 Subject is actively participating or unwilling to discontinue participation in 
another weight loss program.  Subjects may not enroll in paid or unpaid 
programs that involve in-person or online apps or coaching, beginning new 
fitness regimens or utilizing meal planning or paid nutritional coaching during 
the course of the ELIRA study 
7.2.20 Subject is taking weight loss control medications including but not limited to 
OTC medications, Metformin, and Belviq. (See Appendix 8)  
7.2.21 Subject is planning any major medical treatments or surgeries that could 
cause weight loss. 
7.2.22 Subject is unable to take anti-nausea medications planned for the study. 
7.2.23 Inability to walk at least 0.8 kilometers per day (10 minutes of continuous 
walking). 
7.2.24 Current smoker or user of nicotine product or smoking cessation within 1 
year of the screening date. 
7.2.25 History of treatment for or current abuse of drug or alcohol. 
7.2.26 A score of ≥10 on the Patient Health Questionnaire 9 (PHQ-9), 
demonstrating moderate depression. 
7.2.27 Any subject that the investigator considers inappropriate for the study for 
medical reasons.  
7.2.28 Subject has a history of moderate/severe migraines or other severe 
headache disorders requiring the treatment of Topiramate. 
7.2.29 Subject is on drug therapy which may alter antral motility or appetite, per PI 
discretion. (Appendix 8).). 
 
7.3 
SELECTION AND ENROLLMENT OF SUBJECTS 
Prospective study subjects will be screened for study eligibility.  A subject is considered enrolled 
after: 
1. Written Informed Consent is obtained. 
2. Meeting all inclusion and exclusion criteria and randomized into the study. 
3. This study will utilize unique subject numbers for the purpose of trial data collection. 
Subjects signing an Informed Consent but not meeting all criteria will not be 
considered enrolled in the study, but the signed Informed Consents will be 
maintained by the PI for seven (7) years. 
Following enrollment, subjects should remain in the study until completion of the required 
Therapy Phase. 
A subject’s participation may be discontinued for the following reasons: 
• 
Subject Withdrawal: As subject participation in a clinical trial is voluntary, the subject may 
choose to discontinue participation at any time without penalty or loss of benefits. 

26 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
• 
Investigator Termination: The Investigator may terminate the subject’s participation 
without regard to the subject’s consent if the Investigator believes termination is 
medically necessary. 
• 
Lost-to-Follow-up: A subject is lost-to-follow up if he/she does not complete required 
follow-up, but has not “officially” withdrawn consent. In order to consider a subject lost to 
follow-up, site personnel should make all reasonable efforts to locate and communicate 
with the subject. A minimum of three (3) attempts to contact the subject should be 
recorded in the source documentation including date, time and name of site personnel 
attempting to make contact. 
 
8. 
STATISTICAL CONSIDERATIONS AND ANALYSIS PLAN 
Statistical Analysis Plan, 2019MAY31 
 
ELIRA -2 Trial: Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-
Assisted Weight Loss and/or Appetite Suppression 
Protocol Number: CD-005, Original Date:2018MAY08, V4.1, Revised Date:2018AUG14 
 
 

27 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Signature Page 
 
 
Author: Michelle Secic  ___________________________    Date ________________ 
 
Approver: ______________________________________    Date ________________ 
 
Approver: ______________________________________    Date ________________ 
 
 
 

28 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
8. 
STATISTICAL CONSIDERATIONS AND ANALYSIS PLAN 
 
8.1.1 
General Methods 
Categorical variables will be summarized by number and percent.  Continuous variables will be summarized by 
total number (N), mean, standard deviation (SD), median, minimum and maximum.  Ninety-five percent, 2-
sided confidence intervals will be reported, as appropriate. 
As this was a randomized trial, the groups are expected to be balanced on demographic and baseline 
characteristics.  No formal testing for this is planned.   
Planned analyses and summaries for the primary safety endpoint, co-primary efficacy endpoints, secondary 
efficacy endpoints and exploratory efficacy endpoints are detailed below. 
8.1.2 
Analysis Populations  
The intent to treat (ITT) analysis population is defined as all subjects who were enrolled.   
The modified intent to treat (mITT) analysis population is defined as all subjects who initiated therapy (i.e., 
initiated their first Treatment Period Visit) and had data through week 12.  All safety and effectiveness 
analyses will be completed on the mITT analysis population. 
The per protocol (PP) analysis population is defined as all subjects who met all inclusion/exclusion criteria, 
completed all visits in the study without any major protocol deviations.  All effectiveness analyses will be 
completed on the PP analysis population. 
8.1.3 
Safety Analyses 
The primary safety endpoint is defined as the proportion of subjects free of TENS-related serious adverse 
events and adverse device effects through the therapy phase, safety success rate.  The success rates will be 
compared between groups using chi-square test or Fisher’s exact test, as appropriate. 
8.1.4 
Efficacy Analyses 
Co-Primary Efficacy Analyses 
The percent change from baseline in the co-primary endpoints, appetite suppression scores, at the end of 3 
months will be analyzed with analysis of covariance (ANCOVA), with a factor for group treatment and a 
baseline covariate for the appetite score at baseline.  Specifically, the appetite suppression scores include four 
individual components (satisfied, full, hungry, eat from Table 1 of the diaries), each ranging from 0 to 100: 
- 
How satisfied do you feel? 0=I am not hungry at all, 100=I have never been more hungry 
- 
How full do you feel? 0=I am completely empty, 100=I cannot eat another bite 
- 
How hungry do you feel? 0=Not full at all, 100=Totally full 
- 
How much do you think you can eat? 0=Nothing at all, 100=A lot 
These scores are captured in a diary once a week with 8 time points.  The weeks are captured as week 0 
through week 24.  The time points at each week include: 
- 
30 minutes before breakfast 
- 
30 minutes after breakfast 
- 
60 minutes after breakfast 
- 
90 minutes after breakfast 
- 
Pre-lunch 

29 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
- 
Midafternoon 
- 
30 minutes before dinner 
- 
Bedtime 
For each of the four appetite suppression variables, the 8 time points at week zero will be average at week 0 
for the baseline score (baseline), and the 8 time points at week 12 will be averaged at week 12 for the 3-month 
score (3month).  Then the primary endpoint of the percentage change at 3 months will be calculated as:
 
100% x (3month – Baseline)/Baseline 
Next, the percent change from baseline in the co-primary endpoint, %TBWL, at the end of 3 months will be 
analyzed with analysis of covariance (ANCOVA), with a factor for group treatment and a baseline covariate for 
the %TBWL at baseline. 
Note that the ANCOVA analyses with last observation carried forward (LOCF) imputation for missing data on 
the mITT population for the co-primary endpoints are the main analyses for the study and if either %TBWL or 
any of the 4 appetite suppression variables result in statistical significance, then the study will be deemed a 
success.   
Secondary Efficacy Analyses 
Area under the curve (AUC) statistics will be provided by group on each of the appetite suppression scores to 
assess the impact of the device on appetite at three months. AUC will be calculated using the trapezoidal 
method for total AUC across 3 months. 
To further understand the time points and weekly diary entries on appetite suppression, all time points and 
weekly entries will be analyzed in a repeated measures analysis of variance (RMANOVA) for each of the four 
appetite suppression endpoints separately.  The RMANOVA will not use percentage changes but will use the 
actual appetite suppression scores with a factor for group treatment, time (week and time point), as well as 
the interaction factor between time and treatment. 
The occurrence rate for subjects experiencing >5% TBWL at the end of 3 months will be compared between 
groups using chi-square test or Fisher’s exact test, as appropriate. 
Blood pressure, blood lipids, and HbA1c at the end of 3 months of the Therapy compared to Baseline between 
groups using t-tests or Wilcoxon rank sum tests, as appropriate. 
The percent change from baseline in BMI at the end of 3 months of the Therapy compared to Baseline 
between groups using t-tests or Wilcoxon rank sum tests, as appropriate. 
Exploratory Efficacy Summaries 
Summary statistics will be provided by visit and by group for the other time points (besides the 3 month time 
point) for percent change from baseline in appetite suppression scores, %TBWL, occurrence rate for >5% 
TBWL, blood pressure, blood lipids, and HBA1c.  In addition, summary statistics will be provided by visit and by 
group for ease of use, prevalence of use errors associated with patch unit and dietary application, and 
preference scores. 
8.2 Justification of Sample Size 
As per the protocol, the calculation sample size for the study is based on conservative imputation of results 
from other studies on weight loss including the use of TENS for weight loss.  The degree of coaching/dietary 
support throughout the present study is moderate intensity lifestyle/weight coaching.  The sample size 
modeling assumes an average of 3.5% TBWL in Control Subjects using diet and exercise alone.  The estimated 
weight loss in Treatment Subjects is modeled from preliminary data on T6/T7 dermatomal TENS when used for 

30 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
weight loss: 6% TBWL.  The variance of the responses in the study (i.e. Standard Deviation) was modeled at +/- 
5% TBWL.  This value was taken from previous dermatomal TENS weight loss study results.  The model 
assumes a 30% drop out rate across groups and an 80% powered endpoint using an adaptive p spending model 
wherein interim posterior probability assessments are allowed after enrolling proscribe cohorts of not less 
than 67% of subjects.  The alpha penalty will be minimized per interim by assessing the relationship between 
stimulation (i.e. dose) and weight loss using Normalized Linear Dynamic Modeling (NLDM) to determine overall 
sample size projected (i.e. futility) rather than assessing the primary hypothesis per se.  Monotonicity will not 
be assumed in this analysis.  This modeling provides an estimate of 80 subjects per group, for a total study size 
of 160 subjects.  However, the protocol allows for enrollment of additional subjects should the interim model 
project under powering of the primary endpoint. 
8.3 Handling of Missing Data 
Every effort will be made to collect all data at each time point in the study.  The PI and the Clinical Data 
Monitor will minimize the amount of missing data by appropriate management of the prospective clinical trial, 
proper screening of subjects, and training of clinicians.  If a subject misses a dietary entry in to either the paper 
or electronic diary, a look back entry for that value is allowed provide for the week preceding the event.  
Outside this window, data will be considered missing.  All partial data available for subjects who drop out 
during the course of the study will be included. 
Missing data will only be imputed for the co-primary endpoints. The LOCF method will be utilized at the 3 
month time point for the two co-primary endpoints of percent change from baseline in appetite suppression 
scores and %TBWL.  The ANCOVA analysis with LOCF on the mITT population for the co-primary endpoints 
were planned for the main analyses for the study to determine study success.  Note, however, by definition, 
the mITT population may not need LOCF as only those with a week 12 visit will be included in the mITT 
population.  A patient, however, may have had a week 12 visit but have missing data on some or all co-primary 
endpoints, in which case LOCF methods will be used. 
To assess the potential effect of missing data on the co-primary effectiveness endpoints, a tipping point 
analysis will be computed for each co-primary endpoint on the mITT population.  If none of the 5 co-
primary endpoints are missing at week 12, the tipping point analysis will be a moot point and will not be 
conducted.  A tipping point analysis involves imputing each missing data point, one-at-a-time until the 
study conclusion is tipped in the other direction (i.e., from statistically significant to non-statistically 
significant or vice versa, from non-statistically significant to statistically significant).8.4 
Subject 
Population for Safety and Effectiveness Analysis 
Safety analyses will be conducted an Intent to Treat (ITT) basis (i.e. all subjects who were enrolled). 
Primary and Secondary effectiveness analyses will be performed on a modified intent-to-treat basis 
(MITT; i.e. all subjects who initiated therapy, defined as subjects who initiated their first Treatment 
Period Visit) as will all per subject effectiveness analyses (e.g. responder analyses). Primary and 
Secondary endpoints (e.g. weight loss, appetite) will also be conducted on a completer, or per protocol 
basis (defined as those subjects that completed all visits in the study). 
8.5 Deviations from the statistical analysis plan 
Any deviations in the analysis of the final data set from the statistical analysis plan will be documented 
and justified in the final report.  
9. 
STUDY PROCEDURES 
The study is divided into four phases as defined below (See Appendix 66 for Schedule of Visits): 

31 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Study Phase 
Definition 
Screening Visit 
Obtain Informed Consent. Completion of Pre-Study Survey. 
Determination of Inclusion and Exclusion criteria (including PHQ-9 
questionnaire; Appendix 3), Medical History and Physical,  Obtain 
Concomitant Medications, Weight Loss History, Blood Pressure, 
Height and Weight, Blood Tests (including a lipid panel, HbA1c, 
and Urine Pregnancy Test for FOCBP. Dispense and Instruct on 
completion of Weekly Diary.  
Randomization / 
Enrollment Visit 
Confirm Inclusion/Exclusion criteria has been met, Weight, blood 
pressure, 
and 
AEs/Concomitant 
Medications 
assessed. 
Completion of baseline TFEQ-R18V2 (Appendix 4). Assessment of 
T6/T7 Dermatomes, UPT for FOCBP (if not done at screening).  
Completion of pre-enrollment photographs. 
Randomization of subject. For both groups (control and treatment) 
train and dispense paper diaries and electronic scale, encourage 
low-calorie diet for duration of study, provide Diet Resources sheet 
(Appendix 18.11) 
In Addition, For Treatment Group only, training) and assessment of 
use of smart phone app and Elira wearable patch system (Appendix 
2); Initiation of therapy and dose adjustment. Provide TENS Clean-
Cote Skin Wipes and/or Alcohol Prep Pads and Cetaphil 
Moisturizing Lotion with instructions on use, following a healthy low-
calorie diet, as needed, dispense smart phone app and Elira 
wearable patch system.  ELIRA Device training (Treatment Group).  
Paper VAS sheets  
Therapy Period 
For Control and Treatment Groups: Confirm Inclusion/Exclusion 
criteria continues to be met, collect blood pressure, AEs, and 
review Adverse Device Events, paper diary (dispense additional 
diaries), weight, blood pressure, assess for AE’s/concomitant 
medications, completion of hunger and Completion of TFEQ-
R18V2, encourage continuation of low-calorie diet at each 
scheduled visit.   Blood Tests taken at 12 weeks for lipids and 
HbA1c.  Photographs will be taken at 12 weeks . 
In Addition, For Treatment Group only: assess for Adverse Device 
Effects at each visit. Collect Elira wearable patch system and 
smart phone and download data, assess subjects use of electronic 
diary, completion paper sheets and stimulation sessions at each 
visit. Dispense smart phone app and Elira wearable patch system 
at each visit.   
End of Study Visit 
For Control and Treatment Groups: Collect the weekly paper diary 
(if subject has not completed the weekly paper diary, he/she will 
reschedule the end of study visit for one week later to allow time 
for completion), Physical, weight, blood pressure, assess for 
AE’s/concomitant medications, UPT for FOCBP, blood pressure, 
completion of PHQ9, TFEQ-R18V2, End of Study Survey, Blood 
Tests (including a lipid panel and HbA1c) and photography.  

32 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
In Addition, Treatment Group only: assess for Adverse Device 
Effects, collect Elira Wearable patch system and smart phone and 
download data, assess subjects use of electronic diary completion 
and stimulation sessions. Assess T6/T7 dermatomes.  Complete 
End of Study Questionnaire. 
 
9.1 
INFORMED CONSENT  
Prior to subject participation in this study, the PI or designee must obtain written Institutional 
Review Board (IRB) approval for the protocol and the Informed Consent Form. 
Once the subject’s eligibility has been determined, the Investigator or person designated by the 
Investigator who has been trained to the Protocol, will explain the nature and scope of the study, 
discuss potential risks and benefits of participation, answer all questions from the subject and 
ask the subject to participate in the study. The study will be explained to the study subject in lay 
terms. If the subject agrees to participate, the Informed Consent must be personally signed and 
dated by the subject and the Investigator or person designated by the Investigator. Any 
additional persons required to sign the Informed Consent by the IRB will also do so. A copy of 
the signed and dated Informed Consent must be provided to the study subject. Study subjects 
will be assured that they may withdraw from the study at any time and for any reason. 
Failure to obtain a signed Informed Consent prior to the procedure constitutes a major Protocol 
deviation. 
9.2 
SCREENING PROCEDURES 
All candidates must be screened for eligibility. A member of the research team assigned to the 
study should review the subject’s medical history to screen for eligibility.  
The following tests and procedures must be performed prior to TENS therapy:  
§ 
Physical examination, medication history, height, weight and BMI. 
§ 
Relevant medical history including subject demographic information and weight loss 
history. 
§ 
Patient Preference Survey and PHQ-9.  
§ 
Urine Pregnancy Test (UPT) for FOCBP; blood lipid panel, HbA1c. 
9.3 
PHYSICAL EXAMINATIONS 
A general physical examination will be performed as well as an examination of organ systems 
(central nervous system [CNS], cardiac, peripheral vascular, pulmonary, musculoskeletal, 
abdominal, dermatologic and lymphatic). The dermatologic exam will focus on Dermatome T6-
T7 site for any active disease, scars, tattoos, or other problems that would make the site 
unacceptable for the TENS Unit. Depilation by waxing, shaving, chemical depilatories or any 
other method in the selected application site is not allowed during the study. 
9.4 
BODY MASS INDEX 
Height and weight without shoes will be used to determine body mass index (BMI) in 
accordance with the BMI Chart (15,16; Appendix 1) and confirmed by NIH BMI Calculator. 
Subjects will be encouraged to wear the same or similar clothing at each visit for more 
consistent weight measurements. 

33 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
9.5 
MEDICAL HISTORY AND DEMOGRAPHICS 
A complete medical history evaluation, including surgical history and demographic data (age, 
gender, race, ethnicity, and highest level of education) and weight loss history will be obtained 
for each subject. 
9.6 
VITAL SIGNS 
Blood Pressure (sitting position after 3 minutes rest) will be measured.   
9.7 
MEDICATIONS 
All medications must be reported on the appropriate case report form (CRF) through the end of 
study. Medications must remain stable from Screening/Baseline through the Therapy Phase of 
the study. The only exception is medications may be changed for subject health or safety 
reasons (but not specifically to attempt to reduce weight loss or appetite).  
9.8 
QUESTIONNAIRES 
All subjects will be required to complete the Pre-Study Survey and PHQ-9 at screening/baseline 
visit. All subjects will be required to complete a VAS diary for hunger and fullness according the 
following schedule:  1 day with 8 entries following enrollment (approximately week 0-1), 1 day 
with 8 entries following the 4, 8, 12, 16 and 20-week visit (approximately week 4) and 1 day with 
8 entries in the last week of the study (approximately week 24).  All subjects will be required to 
complete the TFEQ-R18V2 at enrollment and at each Therapy Visit (Appendix 3). All subjects 
will be required to complete PHQ9-, TFEQ-R18V2 and End of Study Questionnaire at the last 
study visit (Visit 8 or early termination visit). 
9.9 
URINE PREGNANCY TESTS (UPT) 
A urine pregnancy test will be done in the clinic for all females of child-bearing potential 
(FOCBP) prior to enrollment in the study. The results will be recorded. This can be completed 
either at Screening Visit (Visit 0) or Randomization/Enrollment Visit (Visit 1) and at the end of 
study visit. 
9.10 DIET 
Subjects will be encouraged to maintain a healthy lowcalorie diet throughout the study. The 
study doctor and/or research coordinator will provide guidance to assist the subjects on 
maintaining the diet. 
9.11 ELECTRONIC DAILY DIARY DEVICE 
For Treatment Group Subjects only, an Android Smart Phone running a semi-custom daily diary 
application to capture hunger, calories, and weight will be provided. Subjects will be instructed 
on use by PI or designee.  
9.12 STIMULATION 
Refer to the Programming Manual provided with the TENS System for full details on the use of 
the System (Appendix 2). The subject should be instructed to bring their diary (Appendix 5) to 
the Investigator’s office for all office visits to allow for proper downloading of data. 
9.12.1 General information on Stimulation: 
The TENS unit utilizes low intensity electrical stimulation to activate nerve endings 
under the skin. While response to TENS varies typically subjects report a mild tingling 
or burning sensation during and immediately after stimulation session. In addition, mild 
numbness, termed paresthesia, may be experienced.  

34 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
9.12.2 Starting the Therapy Phase 
During the Therapy Phase, the subject’s TENS is programmed to the following 
settings: 
Parameter 
Suggested Initial Setting 
Frequency 
20 Hz (up to 120Hz) 
Pulse-Width 
200µs 
Amplitude 
20mA (Up to 40 mA) 
It is also important that the subject complete the diary during this period. If subject does 
not feel sensation, subject is to notify PI or Coordinator because it may indicate 
improper device function. The TENS unit will be replaced if dropped or becomes 
defective and non-functioning. It is recommended that subjects confirm response to 
stimulation during the office visits. 
10. RISK ANALYSIS 
A detailed description of the potential risks associated with specific aspects of the TENS System 
and diary use are detailed below:  
10.1 RISKS 
10.1.1 Application and post application risks 
While the TENS unit utilized in the present study delivers therapy in a comparable 
manner to standard commercially available TENS units, there are some risks 
associated with the device. These include skin irritation at the site of electrode 
application, numbness and tingling, pain and burning sensations at the site of 
stimulation. Skin irritation may be mild, moderate or severe based on skin sensitivity.  
Study design and PI/staff training has been implemented to maintain subject safety.  In 
addition, there is some chance that subjects may feel some gastrointestinal (GI) 
symptoms including nausea or other GI discomfort (heartburn, dyspepsia, cramping). 
Dropping the unit may cause damage to the TENS unit. Subjects are instructed to 
avoid use of the device if it has been damaged in any way and not to use the device 
while it or any portion of the subject are immersed in water. Subjects are instructed to 
contact PI or designee, if therapeutic sensation is not present. Any discomfort 
associated with TENS should be immediately reported to the PI or designee. 
10.1.2 Risks associated with appetite loss 
While appetite loss is beneficial to weight loss, severe appetite suppression may place 
the subject at risk for hypoglycemia and dehydration which may entail risks to alertness 
and other conditions. Prolonged appetite suppression can cause alterations in mood 
and mental acuity and impact activities of daily living (ADL).  
Adverse Events: The adverse events listed below are anticipated to occur at low 
frequency, and the subject needs to be aware that they may occur. 
From TENS: 
Paresthesia 
Burning sensation 
Pain 
Skin irritation (urticaria) at or near the electrode application site 

35 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Redness at site of stimulation 
Mild swelling at site of electrode stimulation 
Nausea 
GI discomfort 
Dyspepsia 
Heartburn 
Cramping 
Gastroparesis 
 
From appetite loss: 
Mild hypoglycemia 
Dehydration 
Alterations in mood 
Mild trouble sleeping 
Alterations in mental acuity  
Anorexia 
 
From potential use of anti-nausea medication (PI Discretion): 
Drowsiness 
Dizziness 
Constipation 
Stomach upset 
Blurred vision 
Dry mouth/nose/throat may occur 
Mental/mood changes (such as restlessness, confusion) 
Difficulty urinating 
Fast/irregular heartbeat 
 
From potential use of Cetaphil Moisturizing Lotion 
Irritation 
Swelling 
 
10.2 
MINIMIZATION OF RISKS  
Although all of the risks associated with the application and use of the TENS System and their 
respective frequencies may not be fully known at this time, the preceding risks have been 
identified through an extensive literature search and represent the most up to date 
understanding of risks associated with such a study and have been subjected to verification and 
validation testing to ensure that risks have been mitigated to the extent possible. All efforts will 
be made throughout the course of the trial to minimize these risks by: 
1. Selecting an Investigator who is experienced and skilled in weight loss and TENS use; 
2. Using clearly defined Inclusion/Exclusion criteria to ensure that only appropriate subjects 
are enrolled;  
3. Ensuring that the treatment and follow-up procedures are consistent with current medical 
practices. Each subject will receive more extensive clinical follow-up than would typically 
be the case for standard care. These additional clinical follow-ups should increase the 
likelihood of early detection of any adverse events; 

36 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
4. Utilizing a TENS designed so that it can be easily be applied and removed if necessary.  
Device monitoring will be conducted throughout the Therapy Phase to ensure subject 
safety.  
11. ADVERSE EVENTS: DEFINITIONS & REQUIREMENTS 
At each evaluation, the Investigator will determine whether any adverse events (AEs) have 
occurred. For the purpose of this Protocol, an AE is any undesirable clinical occurrence in a 
subject whether or not related to the investigational treatment. Any pre-existing condition that 
exhibits a change in nature, severity or degree of incidence during the clinical study is an AE. 
This definition does not depend on a causal relationship with the device or the Protocol 
requirements. AEs will be tracked and categorized as outlined within the present protocol. 
Subjects are encouraged to report AEs with or without questioning (e.g., How has your health 
been since the last visit?). If it is determined that an AE has occurred, the Investigator will obtain 
all the information required to complete the AE Case Report Form.  
In addition, subjects will be instructed to contact the Investigator and/or designee if any 
significant AEs occur between study evaluation visits. Serious AEs and unanticipated adverse 
device effects will be collected throughout the entire course of the study. 
The Investigator will use the following definitions to assess the relationship of the AE to the use 
of the TENS system and/or daily electronic diary: 
Not Related 
§ 
Not associated with device application 
§ 
Due to an underlying or concurrent illness or effect of another device 
or drug 
Unlikely 
§ 
Little or no temporal relationship to the study device and/or 
§ 
A more likely alternative etiology exists 
Possible 
§ 
Temporal sequence between device application and event is such that 
the relationship is not unlikely or 
§ 
Subject’s condition or concomitant therapy could have caused the AE 
Probable 
§ 
Temporal sequence is relevant or 
§ 
Event abates upon device application completion/removal or 
§ 
Event cannot be reasonably explained by the subject’s condition 
Highly Probably 
§ 
Temporal sequence is relevant and 
§ 
Event abates upon device application completion/removal or event 
recurs on repeated device application 
 
11.1 SERIOUS ADVERSE EVENTS 
All Serious Adverse Events (SAEs) must be reported to the PI (or designee) and sponsor within 
24 hours after any clinical staff member becomes aware of the incident.  
An Adverse Event is considered serious if the event:  
§ 
Led to a death  
§ 
Led to a serious deterioration in the health of the subject that:  
o Resulted in a life-threatening illness or injury;  
o Resulted in a permanent impairment of a body structure or a body function;  
o Required in-subject hospitalization or prolongation of existing hospitalization;  
o Resulted in medical or surgical intervention to prevent permanent impairment to 
body structure or a body function;  
 

37 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
All SAEs need to be followed until the event is resolved (with or without sequelae). The PI or 
designee will decide if more follow-up information is needed in case the event is not resolved at 
study completion. In case of death, all possible information that is available (e.g., autopsy or 
other post-mortem findings), including the possible relationship to the TENS System and/or daily 
electronic diary should be provided. 
11.2 UNANTICIPATED ADVERSE DEVICE EFFECTS 
An unanticipated adverse device effect is defined as any 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 the Protocol or Supplementary Protocol. 
The Investigator must also report the unanticipated adverse device effect to the Institutional 
Review Board (IRB) within their pre-specified timeline. 
12. SPONSOR RESPONSIBILITIES, RECORDS, AND REPORTS 
12.1 GENERAL RESPONSIBILITIES 
The Principal Investigator (PI) maintains the overall responsibility for this study including 
ensuring that the study is conducted according to the regulatory requirements of the United 
States Food and Drug Administration (FDA) (Code of Federal Regulations Title 21), Good 
Clinical Practice (GCP), the Declaration of Helsinki, and other applicable regulatory 
requirements, the Protocol, and any conditions of approval imposed by the Institutional Review 
Board (IRB) and the relevant Competent Authorities. The PI will adhere to general duties as 
outlined by 21 CFR and GCP. 
12.2 SELECTION OF CLINICAL INVESTIGATORS SITE 
The PI and the site are qualified according to these criteria: 
§ 
Adequate subject population available to meet the requirements of the study  
§ 
Adequate time to be personally involved in the study  
§ 
Adequate research staff and resources to support the study  
§ 
Willingness to take the primary responsibility for the accuracy, legibility, and security of 
all study data 
§ 
Willingness to observe confidentiality at all times 
§ 
Associated with an IRB which satisfies all regulatory authority requirements and 
conducts meetings on a regular basis 
§ 
Access to appropriate emergency medical facilities if needed 
§ 
Other requirements as previously noted in Protocol 
 
12.3 TRAINING OF INVESTIGATOR AND SITE PERSONNEL 
The training of the Investigator and appropriate clinical site personnel will be the responsibility of 
the PI, or designee, and may be conducted during a site initiation visit or other appropriate 
meetings. 
12.4 MONITORING 
A Monitor will be assigned to perform source document review to be performed against entries 
on the Case Report Form for the data related to safety and performance outcomes, and a quality 
assurance check will be performed to ensure that the Investigator is complying with the protocol 
and regulations. 
All data entered by the subject onto the electronic diary will be uploaded onto a secure, central 
database. The data in the database are considered source documentation and are protected by 

38 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
auditable change logs. The data and change logs may be monitored by the Clinical Data Monitor 
to confirm data integrity. Further efforts to ensure data privacy and integrity include the removal 
of the network interface (a.k.a. SIM) card from the handheld Smart Phones used in the study to 
ensure that only controlled data download/upload conducted by study coordinators can occur. 
At the completion of the study, the assigned monitor will perform a close-out visit to ensure that 
all clinical trial materials and subject data are properly documented. 
If a member of the research team becomes aware that any individual associated with the study 
is not complying with the signed Investigator Agreement, the Protocol, the Declaration of 
Helsinki, or other applicable regulatory requirements, or any conditions of approval imposed by 
the IRB or Regulatory Authorities, the PI will either secure compliance or, failing to secure 
compliance, will discontinue the individual’s participation in the investigation.  
12.5 REPORTS 
The sponsor will submit appropriate reports to the Regulatory Authorities or the investigational 
site as identified by local regulations. These include unanticipated adverse device effects, 
withdrawal of IRB approval or Regulatory Authority approval, annual progress reports, recall 
information, final reports and device use without Informed Consent.  
12.6 RECORD MAINTENANCE 
The clinical site will maintain study records for at least seven (7) years after the study is 
terminated or according to site and country specific requirements. 
12.7 REGULATORY AUDITS 
Domestic regulatory authorities, the IRB, and an auditor authorized by the sponsor may request 
access to all source documents, case report forms, and other study documentation for on-site 
audit or inspection. Direct access to these documents must be guaranteed by the investigator, 
who must provide support at all times for these activities. Medical records and other study 
documents may be copied during audit or inspection provided that subject names are obliterated 
on the copies to ensure confidentiality. 
The Investigator and/or designee must be available to respond to reasonable requests and audit 
queries made by authorized regulatory representatives during the audit process. 
12.8 CONFIDENTIALITY 
All data and information collected during this study will be considered confidential. All data used 
in the analysis and summary of this study will be anonymous, and without reference to specific 
study subject names. Access to study subject files will be limited to authorized personnel or 
designees of Investigator, and research staff. Authorized regulatory personnel have the right to 
inspect and copy all records pertinent to this study. National regulations regarding confidentiality 
will be followed as appropriate. 
13. INVESTIGATOR RESPONSIBILITIES, RECORDS, AND REPORTS 
13.1 GENERAL RESPONSIBILITIES 
Principal Investigator at the site must:  
§ 
Assure compliance of all staff to the protocol 
§ 
Ensure all staff are trained to the protocol, TENS system and electronic diary 
§ 
Obtain and maintain a copy of the Institutional Review Board (IRB) approved Informed 
Consent form; 

39 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
§ 
Documentation of IRB approval of the final protocol (and amendments if applicable) 
providing evidence of the following: 
o A statement of IRB approval for the proposed study at the institution 
o Clear identification of the reviewed documents (may be done by attaching review 
packet to approval letter) 
o The date the study was approved  
o A statement that the Informed Consent document (revision date referenced) has 
been approved (may be a separate documented letter) 
o A listing of any conditions attached to the approval 
o Identification of the approved Principal Investigator at the site 
o The signature of the IRB chairperson 
 
Until the study is completed, the Investigator will advise the IRB of the study progress at least 
annually. Written approval from the IRB must be obtained yearly to continue the study. Any 
amendments to the protocol, as well as associated consent form changes, will be submitted to 
the IRB and written approval obtained prior to implementation. Serious adverse event reports 
will be submitted as requested by the IRB. 
13.2 INFORMED CONSENT 
A copy of the Informed Consent must be forwarded to the IRB. All study subjects must provide 
written informed consent using an IRB-approved Informed Consent. The study must be 
explained to the study subjects in English. The Principal Investigator at the site, or designated 
representative, must be available to answer all of the study subject’s study-related questions. 
Study subjects will be assured that they may withdraw from the study at any time for any reason 
and receive alternative conventional therapy as indicated. 
13.3 PROTOCOL DEVIATIONS 
A Protocol Deviation is defined as an event where the Investigator or site personnel did not 
conduct the study according to the Protocol. 
Investigators must approve any major deviations from the Protocol, except where necessary to 
protect the life or physical well-being of a subject in an emergency. Such approval shall be 
documented in writing and maintained in clinical study management files. Prior approval is 
generally not expected in situations where unforeseen circumstances are beyond the 
Investigator’s control; however, the event is still considered a deviation and must be reported on 
the appropriate Case Report Form (CRF). 
Deviations must be reported to the PI regardless of whether medically justifiable, pre-approved 
or performed to protect the subject in an emergency. Subject-specific deviations will be reported 
on a Protocol Deviation CRF.  
Regulations require that the PI and site maintain accurate, complete and current records, 
including documents showing the dates of and reasons for each Protocol Deviation. For 
reporting purposes, Protocol Deviations are defined as major and minor as follows: 
Major Deviation: 
Any deviation from subject Inclusion and Exclusion 
criteria, subject Informed Consent procedures or 
authorized device use. 
Minor Deviation: 
Deviation from a protocol requirement such as 
incomplete/inadequate subject testing procedures, 
follow-ups performed outside specified time windows, 
etc. 

40 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Minor Deviations that continue to occur may be classified as Major Deviations if corrective action 
is not taken to secure future compliance to the Protocol. 
13.4 REPORTING REQUIREMENTS 
As required by the IRB, the Investigator is responsible for reporting study progress to the IRB at 
least annually. The Investigator/Sponsor, as required by the local regulations, should notify the 
IRB in writing after completion, termination, or discontinuation of the study at the site. If the study 
is discontinued due to safety concerns, the Investigator will notify the IRB immediately. 
Timelines for notification are dependent on IRB requirements. 
13.5 SOURCE DOCUMENTS 
Source documents are defined as original documents, data and records. These may include 
hospital records, clinic and office charts, laboratory data/information, and recorded data from 
automated instruments, subject-reported data collected from the diary and transmitted to the 
secure database, microfiches, photographic negatives, microfilm or magnetic media, and/or x-
rays. 
The Investigator shall maintain all source documents as required by the Protocol, including 
laboratory results (e.g., pregnancy tests), subject report forms, supporting medical records, and 
Informed Consent forms for at least seven (7) years after the study is terminated or according to 
site and country specific requirements. 
13.6 ACCESS TO SOURCE DATA/DOCUMENTS 
The Investigator/institution will permit direct access to source data/documents in order for IRB 
review and regulatory inspections to be performed. These data may be shared with regulatory 
agencies. 
13.7 DATA COLLECTION 
Required data for this study will be captured on standardized CRFs. CRFs will be completed and 
stored for data analysis. Any deficiencies identified on the CRF will be communicated to the PI 
by the Clinical Data Monitor as appropriate. 
13.8 ON-SITE AUDITS 
The Investigator and/or designee must be available to respond to reasonable requests and audit 
queries made by authorized regulatory representatives during the audit process.  
14. SITE MONITORING PROCEDURES 
A Clinical Data Monitor will be responsible for the monitoring of this study. Responsibilities may 
be shared with Investigator or designee and include:  
1. Conducting site initiation visits (training to product and protocol) after Institutional Review Board 
(IRB) approval and before first subject enrollment. 
2. Maintaining regular contact with the site through telephone contact, email and on-site visits. 
3. Assuring that the Protocol is followed; verifying that complete, timely and accurate data are 
submitted. 
4. Monitoring subject data, including: reviewing Case Report Forms (CRFs) for completeness, 
verifying data to source documentation including operator worksheets retained with CRF 
documentation and hospital charts, and addressing problems with inconsistent, illegible and/or 
incomplete data.  
5. Assuring that the Investigator’s study file is maintained and that the site facilities continue to be 
adequate. 

41 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
6. Conducting a close-out visit after completion of all CRFs. 
 
During the study, the study site will be visited periodically by the Clinical Data Monitor. The 
Clinical Data Monitor will ensure Protocol compliance, accurate recording of results, reporting of 
adverse events, and record keeping. The Clinical Data Monitor will evaluate and summarize the 
results of each site visit in written reports, identifying any repeated data problems with any 
Investigator and specifying recommendations for resolution of noted deficiencies. 
15. DATA QUALITY ASSURANCE 
Standard Case Report Forms (CRFs) will be provided for use at all investigational sites. The 
Investigator is responsible for completion and timely submission of the forms for data entry and 
analysis.  For subject reported outcome information recorded by the subject in the smartphone 
app diary, an audit trail will ensure any changes made to the data are properly attributed and 
have been reviewed and approved by the Investigator. 
Subject data obtained from the CRFs and diary data from the handheld diary will be maintained 
by the PI, the management of these data will be compliant with the relevant parts of United 
States (US)CRF data regulations, including CFR Part 11. 
Data entry will be performed by the Clinical Data Manager or designee. 
Quality assurance procedures are designed to ensure that complete, accurate and timely data 
are submitted, that Protocol requirements are followed, and that complications, Adverse Events 
(AEs) and adverse device effects (ADE) are correctly reported. 
Incoming data are reviewed to identify inconsistent or missing data and AEs/ADEs. Any data 
issues will be addressed with the Principal Investigator at the site. All hard copy forms and data 
files will be secured to ensure confidentiality. 
 
16. ETHICAL REQUIREMENTS 
16.1 DECLARATION OF HELSINKI  
The study will be performed in accordance with ISO/EN 14155, parts 1 and 2, recommendations 
guiding physicians in biomedical research involving humans adopted by the 18th World Medical 
Assembly, Helsinki, Finland (1964 and later revisions), United States Food and Drug 
Administration (FDA) regulations, and International Congress on Harmonization (ICH) and Good 
Clinical Practice (GCP) guidelines. 
It is the responsibility of the Principal Investigator at the site to obtain approval of the study 
protocol from the competent Institutional Review Board (IRB) and to keep them informed of any 
Serious Adverse Events (SAEs), serious adverse device effects, and Protocol amendments. All 
correspondence with the IRB should be filed by the Investigator  
16.2 SUBJECT INFORMATION AND CONSENT  
It is the responsibility of the Investigator to give each subject full and adequate verbal and 
written information regarding the objectives and procedures of the study and the possible risks 
involved, and to obtain signed Informed Consent from all subjects prior to inclusion in the study.  
The original, signed Informed Consent is filed with the subject study records, and a copy is 
provided to the subject. 

42 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
16.3 SUBJECT DATA PROTECTION 
The subjects will be identified in the Case Report Forms (CRFs) with a unique subject number 
and initials. 
Per applicable regulations, the subject must be informed that the data will be stored and 
analyzed by computer, that national regulations for handling of computerized data will be 
followed, and that only the Investigator and designated research staff will have access to 
individual subject data. Furthermore, the subjects should be informed about the possibility of 
inspection of relevant parts of the hospital records by Health Authorities. 
16.4 REPORTING AND COMMUNICATION OF RESULTS 
All information and data generated in association with this study will be held in strict confidence 
and remains the sole property of PI. 
16.5 CLINICAL TRIAL TERMINATION 
A subject’s participation in the clinical trial will be terminated if the Investigator believes it is in 
the subject’s best medical interest or if the subject no longer complies with the clinical trial 
requirements. The subject may also decide to withdraw from the clinical trial at any time and 
terminate participation. The IRB and/or other Regulatory Authorities may decide to interrupt this 
clinical trial if either believes that this is necessary. 
16.6 PROTOCOL MODIFICATIONS AND DEVIATIONS  
The PI will submit Protocol modifications to the IRB as necessary. 
 

43 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
17. BIBLIOGRAPHY 
1. 
Centers for Disease Control (CDC) Faststats. http://www.cdc.gov/nchs/fastats/obesity-
overweight.htm citing Table 55 from CDC Health, United States 2014 Report: pp 215.  
2. 
Fatemeh Azizi Soeliman and Leila Azadbakht. Weight loss maintenance: A review on 
dietary related strategies J Res Med Sci. 2014 Mar; 19(3): 268–275.  
3. 
LeCheminant JD, Jacobsen DJ, Hall MA, Donnelly JE. A comparison of meal replacements 
and medication in weight maintenance after weight loss. J Am Coll Nutr. 2005;24:347–53.  
4. 
Legenbauer TM, De Zwaan M, Mühlhans B, Petrak F, Herpertz S. Do mental disorders and 
eating patterns affect long-term weight loss maintenance? Gen Hosp 
Psychiatry. 2010;32:132–40.  
5. 
Boyle DJ, Prosser K, Allison ME, et al. Percutaneous tibial nerve stimulation for the 
treatment of urge fecal incontinence. Dis Colon Rectum. 2010;53:432-7.  
6. 
Moossdorff-Steinhauser HF, et al. Effects of percutaneous tibial nerve stimulation on adult 
subjects with overactive bladder syndrome: a systematic review. Neurourol Urodyn. 
2013;32(3):206-14.  
7. 
Ridout AE, et al. Tibial nerve stimulation for overactive bladder syndrome unresponsive to 
medical therapy. J Obstet Gynaecol. 2010;30(2):111-4.  
8. 
Van der Pal F, Van Balken MR, Heesakkers JP, et al. Percutaneous tibial nerve stimulation 
in the treatment of overactive bladder syndrome: is maintenance treatment a necessity? 
BJU Int. 2006;97:547-50.  
9. 
Dr. Jaime Ruiz-Tovar Percutaneous Electrical Neurostimulation of Dermatome T6 for 
Appetite Reduction and Weight Loss in Morbidly Obese Subjects Obesity Surgery 2014 24: 
205-211. 
10. Lemanu DP, Srinivasa S, Singh PP, et al. Laparoscopic sleeve gastrectomy: its place in 
bariatric surgery for the severely obese patient. N Z Med J. 2012; 125:41-9. 6. 
11.  Chen J. Mechanisms of action of the implantable gastric stimulator for obesity. Obes Surg. 
2004;14 Suppl 1:S28-32.  
12. Wadden, T.A and S. Phelan. Assessment of quality of life in obese Individuals. Obesity 
Research. 2002; 10, Issue Supplement11, 50S–57S. 
13. Burns, C.M, MAR Tijhuis and JC Seidell. The relationship between quality of life and 
perceived body weight and dieting history in Dutch men and women. Intl. Jl. Obesity. 2001; 
25: 1386-1392 
14. Blundell, J., C.deGraaf et.al. (2010). Appetite control: methodological aspects of the 
evaluation of foods. Obes. Res. 11(3): 251-270.  
15. 
Metropolitan Life Insurance Company. New weight standards for men and women. Stat 
Bull Metrop Life Insur Co. 1959;40:1–10. 
16. 
1983 Metropolitan Height and Weight Tables. Stat Bull Metropolitan Life Insurance Co. 
1984;64:2–9. 
17. 
Cappelleri, J.C., A.G. Bushmakin et.al. (2009). Psychometric analysis of the Three-Factor 
Eating Questionnaire-R21: results from a large diverse sample of obese and non-obese 
participants. Intl. Jl. Of Obesity 33:611-620. 
18. 
Angle, S., J. Engblom et.al. (2009) Three factor eating questionnaire-R18 as a measure of 
cognitive restraint, uncontrolled eating and emotional eating in a sample of young Finnish 
females. In. J. Behav.Nutr. Phys. Act. 6: 41. 
 
 
 

44 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18. APPENDICES 
 
18.1 APPENDIX 1: BMI RANGES 
TARGETED FOR MEN AND WOMEN 
ENROLLED IN STUDY (AN EXAMPLE 
OR NIH ONLINE SOURCE) 15,16 
 
Males (target BMI indicated by Black Bars): 
 
Females (target BMI indicated by Black Bars): 

45 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
 
  
 

46 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18.2 APPENDIX 2: TENS UNIT USER MANUALS (ADDITIONAL FILE SUBMITTED SEPARATELY) 
 
 
 
 
 

47 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18.3 APPENDIX 3: PHQ-9 
QUESTIONNAIRE 
 
 
PATIENT HEALTH QUESTIONNAIRE-9 (PHQ-9)  
Over the last 2 weeks, how often have you been 
bothered by any of the following problems? (Use “✔” to 
indicate your answer)  
Not at all  
Several 
days  
More 
than half 
the days  
Nearly 
every 
day  
1. Little interest or pleasure in doing things  
0  
1  
2  
3  
2. Feeling down, depressed, or hopeless  
0  
1  
2  
3  
3. Trouble falling or staying asleep, or sleeping too much  
0  
1  
2  
3  
4. Feeling tired or having little energy  
0  
1  
2  
3  
5. Poor appetite or overeating  
0  
1  
2  
3  
6. Feeling bad about yourself — or that you are a failure or 
have let yourself or your family down  
0  
1  
2  
3  
7. Trouble concentrating on things, such as reading the 
newspaper or watching television  
0  
1  
2  
3  
8. Moving or speaking so slowly that other people could 
have noticed?  Or the opposite — being so fidgety or 
restless that you have been moving around a lot more than 
usual  
0  
1  
2  
3  
9. Thoughts that you would be better off dead or of hurting 
yourself in some way  
0  
1  
2  
3  
                                                                                                              FOR OFFICE CODING     0      + ______  +  ______  +  ______  
=Total Score:  ______  
 
If you checked off any problems, how difficult have these problems made it for you to do your 
work, take care of things at home, or get along with other people?  
Not difficult  
at all  
¨  
Somewhat  
difficult  
¨  
Very  
difficult  
¨  
Extremely  
difficult  
¨  
 
Developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, w ith an educational grant from 
Pfizer Inc.  No permission required to reproduce, translate, display or distribute.  
 
 
 
 
 
 
 
 
Subject Initials:___________ 
 
 
 
 
 
 
 
 
Date:___________________ 

48 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18.4 APPENDIX 4: TFEQ-R18V2 17 
The Three-Factor Eating Questionnaire  
  
Please read each statement and select from the multiple-choice options the answer that indicates the frequency  
with which you find yourself feeling or experiencing what is being described in the statements below.  
  
1. When I smell a delicious food, I find it very difficult to keep from eating, even if I have 
just finished a meal.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
2. I deliberately take small helpings as a means of controlling my weight.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
3. When I feel anxious, I find myself eating.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
4. Sometimes when I start eating, I just can’t seem to stop.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
 
5.  Being with someone who is eating often makes me hungry enough to eat also. 
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
 
6. When I feel blue, I often overeat.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
7. When I see a real delicacy, I often get so hungry that I have to eat right away.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
8. I get so hungry that my stomach often seems like a bottomless pit.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
9. I am always hungry so it is hard for me to stop eating before I finish the food on my plate.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
 
10. When I feel lonely, I console myself by eating.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
11. I consciously hold back at meals in order not to weight gain.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  

49 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
12. I do not eat some foods because they make me fat.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
13. I am always hungry enough to eat at any time.   
 
Definitely true (4)  /  mostly true (3)  /  mostly false (2)  /  definitely false (1)   
  
14. How often do you feel hungry?   
 
Only at meal times (1)  /  sometimes between meals (2)  /  often between meals (3)  / almost always (4)   
  
15. How frequently do you avoid “stocking up” on tempting foods?  
 
Almost never (1)  /  seldom (2)  /  moderately likely (3)  /  almost always (4)  
  
16. How likely are you to consciously eat less than you want?  
 
Unlikely (1)  /  slightly likely (2)  /  moderately likely (3)  /  very likely (4)  
  
17. Do you go on eating binges though you are not hungry?  
 
Never (1)  /  rarely (2)  /  sometimes (3)  /  at least once a week (4)  
 
18. On a scale of 1to 8, where 1 means no restraint in eating (eating whatever you want, whenever you want it) and 8 means 
total restraint (constantly limiting food intake and never “giving in”), what number would you give yourself?   
 
Revised 18-Item (Karlsson et. Al. 2000)  
 
 
 
 

50 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18.5 APPENDIX 5:  VAS AND DAILY 
DIARY APPLICATION 
Recommended primary scales for self-reported appetite in healthy adultsa 
Scale 
Question 
Anchors 
Low 
High 
Hunger 
How hungry are you? 
I am not hungry at all 
Extremely 
I have never been more 
hungry 
Fullness How full are you? 
I am completely empty 
I cannot eat another bite 
aLine scales 100-150 mm (paper) or appropriate length for electronic capture systems are to be used for each of 
these questions.  
 
 

51 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
 

52 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
18.6 APPENDIX 6: SCHEDULE OF EVENTS 
APPENDIX 6: SCHEDULE OF VISITS 
STUDY PERIOD 
SCREENING 
ENROLLMENT 
THERAPY/CONTROL 
END OF 
STUDY7 
VISIT # 
VISIT 0 
VISIT 1 
VISIT 2 
VISIT 3 
VISIT 4 
VISIT 5 
VISIT 6 
VISIT 7 
VISIT8 
WEEK # 
WEEK -1 
WEEK 0 
WEEK 1 
WEEK 4 
WEEK 8 
WEEK 12 
WEEK 16 
WEEK 20 
WEEK 24 
VISIT WINDOW1 
±7 DAYS 
±7 DAYS 
±7 DAYS 
±7 DAYS 
+/- 7 DAYS 
+/- 7 DAYS 
+/- 7 DAYS 
±7 DAYS 
± 7 DAYS 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Medical History 
X 
 
 
 
 
 
 
 
 
Diet History 
X 
 
 
 
 
 
 
 
 
Physical Exam 
X 
 
 
 
 
 
 
 
X 
T6/T7 dermatome assessment 
X3 
X3 
X4 
X4 
X4 
X4 
X4 
X4 
X4 
Blood Pressure 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Height  
X 
 
 
 
 
 
 
 
 
Weight  
X 
X 
X 
X 
X 
X 
X 
X 
X 
Laboratory Requisition - Blood Tests 2 
X 
 
 
 
 
X 
 
 
X 
Urine Pregnancy Test (FOCBP) 
X 
X6 
 
 
 
 
 
 
X 
Administration of PHQ-9 
X 
 
 
 
 
 
 
 
X 

53 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
Administration of TFEQ-R18V2 
 
X 
X 
X 
X 
X 
X 
X 
X 
Administration of Pre-Study Survey 
X 
 
 
 
 
 
 
 
Administration of Post-Study Survey 
 
 
 
 
 
 
 
 
X 
Provide/Train on Paper Diaries3 
X 
X 
 
X 
X 
X 
X 
X 
 
Collect and Review Paper Diaries3 
 
 
X 
X 
X 
X 
X 
X 
X 
Randomization5 
 
X 
 
 
 
 
 
 
 
Provide/Train on Electronic Scale 
 
X 
 
 
 
 
 
 
 
Provide and Train on Electronic Diary 
Application4 
 
X 
X 
X 
X 
X 
X 
X 
 
Collect and Review Electronic Diary4 
 
 
X 
X 
X 
X 
X 
X 
X 
Provide and Train on TENS Unit and 
Patches4 
 
X 
X 
X 
X 
X 
X 
X 
 
Collect and Examine TENS Unit and 
Patches4 
 
 
X 
X 
X 
X 
X 
X 
X 
Training on Electrode Placement4 
 
X 
X 
X 
X 
X 
X 
X 
 
Adjust TENS Unit, if applicable4 
 
X 
X 
X 
X 
X 
X 
X 
 
Provide/instruct (as needed) on TENS 
Clean-Cote Skin Wipes an/or Alcohol Prep 
Pads4 
 
X 
X 
X 
X 
X 
X 
X 
 
Provide/Instruct (as needed) on Cetaphil 
Lotion4 
 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant Medication Review3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Assessment of Adverse Events3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Assessment of Adverse Device Effects4  
 
X 
X 
X 
X 
X 
X 
X 
X 
Schedule next visit 
X 
X 
X 
X 
X 
X 
X 
X 
 
Photographs taken 
 
X 
 
 
 
X 
 
 
X 
Study Exit 
 
 
 
 
 
 
 
 
X 
1 – all visits are ± 1 week 
2 – Blood tests include HbA1c, lipid panel,   
3 – to be completed for control and treatment group 
4 – to be completed for treatment group only  
5 – randomization into control or treatment group 
6- Either Screening or Randomization Visit, Not Needed at Both.                        
 
 

54 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18.7 APPENDIX 77: ELECTRONIC DIARY 
APPLICATION (SEE SAMPLES 
SCREEN SHOTS)  
 
 
 
 
 

55 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
18.8 APPENDIX 8: LIST OF POTENTIAL 
DRUG INTERACTIONS  
 
*List of drugs includesdrugs includes some pharmaceuticals that may impact study participation. 
May not be complete and is up to PI discretion. 
 
 

56 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18.9 APPENDIX 9: END OF STUDY 
SURVEY 
 
Name or Subject Identifier:  __________________________________________ 
 
ELIRA End of Study Survey 
Thank you for completing the weight loss study.  Please circle your response to each question below. 
1. My experience wearing the device and using the associated app can be described as (enter text below): 
 
 
2. What I liked MOST about this product (circle all that apply): 
o 
Non-invasive / non-surgical 
o 
Helps control appetite 
o 
Easy to use 
o 
Technology / app component 
o 
Convenience / automatic nature 
o 
No medications or pills 
o 
Wearable 
o 
Low side effects 
o 
Discreet 
o 
FDA cleared 
o 
Other (please specify): _____________________________________ 
 
3. What I liked LEAST about this product (circle all that apply): 
o 
Safety 
o 
Side effects 
o 
Efficacy (Effectiveness) 
o 
Sensation while wearing it 
o 
Skin patch / wearable 
o 
Having to connect to a smartphone 
o 
Not natural or healthy way to lose weight 
o 
Other (please specify): _____________________________________ 
 
4. Overall, this product helped suppress my appetite (circle one): 
o 
Always 
o 
Most of the time 
o 
Occasionally 
o 
Never 

57 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
5. I found that the instant sessions helped suppress my appetite (check one): 
o 
Always 
o 
Most of the time 
o 
Occasionally 
o 
Never 
 
6. Please indicate your level of agreement with the following statements (check one box for each 
statement): 
 
Strongly 
disagree 
Somewhat 
disagree 
Neutral 
Somewhat 
agree 
Strongly 
agree 
The product easily fits my daily lifestyle. 
 
 
 
 
 
Wearing this product was comfortable 
 
 
 
 
 
I got used to using this product quickly. 
 
 
 
 
 
The app was easy to use 
 
 
 
 
 
The device seems safe. 
 
 
 
 
 
 My appetite was lower than normal while 
using this product. 
 
 
 
 
 
The product helped me lose more weight 
than I could have on my own. 
 
 
 
 
 
I am happier with how I look and feel after 
wearing this product. 
 
 
 
 
 
I wish I could continue wearing this product. 
 
 
 
 
 
I believe this product would work for most 
people. 
 
 
 
 
 
I would recommend this product to my 
friends. 
 
 
 
 
 
7. Where would you expect that patients could purchase the Elira device?  Circle all that apply. 
o 
From my aesthetic physician (dermatologist, plastic surgeon, medspa) 
o 
From my general practioner or internal medicine physician 
o 
From my OB/GYN 
o 
From a weight lost cinic 
o 
Other (please specify):  _____________________ 
 
7. What barriers to your normal lifestyle did using this product create: 
 
 
8. I wish the following additions/changes could be made to the device: 
 

58 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
9. I wish the following additions/changes could be made to the Smartphone application: 
 
 
10. I would pay this much money out-of-pocket for this device:  ____________ 
 
11. I am willing to be contacted by Elira for more details on my experience after this trial to help improve the 
product design: 
o 
YES 
o 
NO 
 
12. I am willing to allow Elira to use this information as a user testimonial (using my first name only): 
o 
YES 
o 
NO 
 
 
 

59 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18.10 
APPENDIX 10: PRE-STUDY 
SURVEY 
 
 
Name or Subject Identifier:  __________________________________________ 
 
ELIRA Pre-Study Survey 
Thank you for your interest in the weight loss study.  Please circle your response to each question below. 
 
1. How much weight do you think you need to lose?  
a. None 
b. Less than 5 lbs 
c. 5 – 10 lbs 
d. 11 – 15 lbs 
e. 16 – 20 lbs 
f. 
More than 20 lbs 
g. Not sure 
 
2. A number of weight loss programs offer the potential to lose 1-2 lbs per week. Do you consider this a 
reasonable amount of weight for you to lose per week in a weight loss program? 
a. Yes 
b. No, I would expect to lose less than 1 pound per week 
c. No, I would expect to lose more than 2 pounds per week 
 
3. Which, if any, of the following have you attempted in order to lose weight in the past? Select all that 
apply. 
a. Dieting on your own (not through a specific program) 
b. Dieting with free online coaching or support (like MyFitnessPal) 
c. Exercise or increasing amount of exercise 
d. Paid weight loss program (Jenny Craig / Weight Watchers, etc.)  
e. Gym membership 
f. 
Medical weight loss through a physician 
g. Prescription diet pills or other prescription medications 
h. Over-the-counter diet pills or appetite suppressants 
i. 
Surgical or other invasive procedures, e.g. gastric balloons or LAP-band 
j. 
Body sculpting targeting specific areas, e.g. Cool Sculpting 
k. Other (please specify) 
l. 
I haven’t tried to lose weight in the past 
 
4. How would you describe your level of success with prior weight loss methods? 
a. I was able to lose weight and keep all or most of the weight off 
b. I was able to lose weight but regained some or most of the weight back 
c. I was not able to lose weight  
 
5. What is the primary reason you want to lose weight?  Please circle one. 
a. Better health  
b. Improved appearance 
c. Lifestyle (e.g. being more acrive) 
d. Recommended by my Company’s wellness program 
e. Special event (wedding, reunion, party, etc.) 

60 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
f. 
Other (please specify) ___________________ 
 
6. Is it easy or difficult for you to lose weight? 
a. Very easy 
b. Somewhat easy 
c. Sometimes easy, sometimes difficult 
d. Somewhat difficult 
e. Very difficult 
f. 
I’ve never tried to lose weight before 
 
7. What are your primary barriers to weight loss? Select all that apply.  
a. Time 
b. Cost 
c. Willpower 
d. Appetite control 
e. Fear of failure 
f. 
Concerns about side effects of medication or surgery 
g. Other (please specify) 
 
8.  Please indicate your level of agreement with the following statements 
 
Strongly 
disagree 
Somewhat 
disagree 
Neutral 
Somewhat 
agree 
Strongly 
agree 
I always try to look and feel my best 
 
 
 
 
 
I try to keep up with the latest trends 
 
 
 
 
 
How you look on the outside says a lot about you 
 
 
 
 
 
I enjoy shopping for new clothes 
 
 
 
 
 
I would be more confident if I lost weight 
 
 
 
 
 
I feel like I’m hungry more often than other people 
 
 
 
 
 
Hunger is my biggest barrier to losing weight when 
dieting. 
 
 
 
 
 
I have talked to a friend or family member about 
trying to lose weight 
 
 
 
 
 
I have been frustrated by my weight for a long time 
 
 
 
 
 
I wish I could control how much I eat 
 
 
 
 
 
I wish I could lose weight without exercising 
 
 
 
 
 
Losing weight is a very difficult process 
 
 
 
 
 
Posiitve messages motivate me to stay on track 
with  my goals. 
 
 
 
 
 
 
 
 
 
 
 
 

61 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
18.11 
APPENDIX 11: DIET 
GUIDELINES 
 
 
The Centers for Disease Control and Prevention has information available online that you 
may want to reference.  Some helpful information and links are below: 
 
“Whether you need to lose weight, maintain your ideal weight, or gain weight, the main message is – 
calories count! Weight management is all about balancing the number of calories you take in with 
the number your body uses or “burns off.” 
 
If you need to lose weight, you’ll need to reduce your daily calorie consumption in line with your 
goal.  An adult can lose 1 to 2 pounds per week by eating 500-1,000 fewer calories per day.  During 
this study, try to reduce your calorie intake as much as possible.” 
 
 
Links to specific pages on the CDC website are below: 
Losing Weight:  https://www.cdc.gov/healthyweight/losing_weight/index.html 
Healthy Eating:  https://www.cdc.gov/healthyweight/healthy_eating/index.html 
Cutting Calories:  https://www.cdc.gov/healthyweight/healthy_eating/cutting_calories.html 
Meal Ideas: https://www.cdc.gov/healthyweight/healthy_eating/cutting_calories.html 
 
  
 
 
 
 
 
 

62 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
 
 
 
18.12 
TRIAL COMPONENTS 
 
 
 
 

63 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential- 
 
 
 
 
 
 
 
 

64 | P a g e  
 
E L I R A - 2  
 
Protocol #: CD-005; Version #: 4.0 
Original Date: May 8, 2018 Revision Date: May 3, 2019 
-Confidential-