A Retrospective Record-review Study in Patients Who Had Participated in the ON101CLCT02 Diabetic Foot Ulcer Trial
Conditions: Diabetic Foot Ulcer
Sponsor: Oneness Biotech Co., Ltd.

 
RETROSPECTIVE STUDY 
PROTOCOL  
 
A Retrospective Record-review Study in Patients 
Who Had Participated in the ON101CLCT02 
Diabetic Foot Ulcer Trial 
 
NCT#: NCT05135130 
 
 
Principal Investigator:  Hsin-Han Chen, M.D.  
Development phase: 
NA 
Sponsor:  
Oneness Biotech Co., Ltd. 
Version Number:  
V1.1 
Date 
03-Sep-2021 
 
 
 
All the information disclosed or provided by Oneness Biotech Co., Ltd. or produced during the study, including 
this protocol, the CRFs, and the results obtained during the study, is confidential and is intended for the use of 
clinical investigators, and any person under his/her authority agree to keep confidential. This protocol is the 
property of Oneness Biotech Co., Ltd. and should not be copied, distributed to persons not involved in this 
clinical trial, or published without the permission of Oneness Biotech Co., Ltd.. 
 

Protocol No.: ON101CLOS01 
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Protocol version: v1.1 
Date: 03-Sep-2021 
AMENDMENT HISTORY 
Amendment 
No. 
Version 
No. 
Version 
Date 
Authors of 
changes 
Summary of Revisions  
1 
V1.1 
03-Sep-
2021 
Sponsor 
1. Remove the questionnaire part 
(original 3.4.2) in the research 
method 
2. Remove the outcomes related to 
non-medical cost and QoL 
3. Remove the subgroups related to 
the patients’ current statuses. 
 
 
 
 
 
 
 
 
 
 

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INVESTIGATOR SIGNATURE PAGE 
 
The study will be carried out in accordance with the protocol, the International Conference on 
Harmonisation guidelines for Good Clinical Practice (ICH E6), and in accordance with local legal 
and regulatory requirements. All personnel involved in the conduct of this study have 
completed human subject protection training. 
 
 
Principal Investigator 
                            
Name, Title  
Signature: 
                        
Date: 
                      
 
 
 
 
 

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SPONSOR SIGNATURE PAGE 
 
The study will be carried out in accordance with the protocol, the International Conference on 
Harmonisation guidelines for Good Clinical Practice (ICH E6), and in accordance with local legal 
and regulatory requirements. All personnel involved in the conduct of this study have 
completed human subject protection training. 
 
 
 
 
Sponsor’s representative: 
____________________________________     
Name, Title  
Signature: 
                        
Date: 
                      

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CONTACT INFORMATION OF KEY ROLES 
PRINCIPAL INVESTIGATOR 
Name 
Hsin-Han Chen, M.D. 陳信翰 醫師 
Address 
China Medical University Hospital 
No. 2, Yude Rd., North Dist., Taichung City 404, Taiwan (R.O.C.) 
Tel 
886-4-2205-2121 
Email 
scapulachenhh@yahoo.com.tw 
PRINCIPAL INVESTIGATOR 
Name 
Nai-Chen Cheng, M.D. 鄭乃禎 醫師 
Address 
National Taiwan University Hospital 
No. 7, Zhongshan S. Rd., Zhongzheng Dist., Taipei City 100, Taiwan (R.O.C.) 
Tel 
886-2-2312-3456 
Email 
nccheng@ntu.edu.tw 
PRINCIPAL INVESTIGATOR 
Name 
Kwang-Yi Tung, M.D. 董光義 醫師 
Address 
MacKay Memorial Hospital 
No. 92, Sec. 2, Zhongshan N. Rd., Zhongshan Dist., Taipei City 104, Taiwan (R.O.C.) 
Tel 
886-2-2543-3535 
Email 
tung@ms2.mmh.org.tw 
PRINCIPAL INVESTIGATOR 
Name 
Niann-Tzyy Dai, M.D. 戴念梓 醫師 
Address 
Tri-Service General Hospital 
No. 325, Sec. 2, Chenggong Rd., Neihu Dist., Taipei City 114, Taiwan (R.O.C.) 
Tel 
886-2-8792-3311 
Email 
niantzyy@ms17.hinet.net 
PRINCIPAL INVESTIGATOR 
Name 
Yu-Yao Huang, M.D. 黃禹堯 醫師 
Address 
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital 
No. 5, Fuxing St., Guishan Dist., Taoyuan City 333, Taiwan (R.O.C.) 
Tel 
886-3-328-1200 
Email 
yyh@cgmh.org.tw 
PRINCIPAL INVESTIGATOR 
Name 
Kuo-Feng, Huang, M.D. 黃國峯 醫師 
Address 
Chi Mei Medical Center 
No. 901, Zhonghua Rd., Yongkang Dist., Tainan City 710, Taiwan (R.O.C.) 

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Tel 
886-6-281-2811 
Email 
huangkuofeng@gmail.com 
PRINCIPAL INVESTIGATOR 
Name 
Pao-Yuan Lin, M.D. 林寶源 醫師 
Address 
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital 
No. 123, Dapi Rd., Niaosong Dist., Kaohsiung City 833, Taiwan (R.O.C.) 
Tel 
886-7-731-7123 
Email 
paoyuan9219@gmail.com 
SPONSOR’S REPRESENTATIVE 
Name 
Shyi-Gen Chen 
Address 
Oneness Biotech Co., Ltd. 
11F, No 236, Sector 4 Xinyi Rd., Daan Dist., Taipei City 106, Taiwan (R.O.C.) 
Tel 
886-2-2703-1098 
Email 
Steven.Chen@onenessbio.com.tw 
CRO REPRESENTATIVE 
Name 
Samuel Su 
Address 
Bestat Pharmaservices Corp. 
6F, No. 277, Sec. 3, Chengde Rd., Datong Dist., Taipei City 103, Taiwan (R.O.C.) 
Tel 
886-2-2595-5590 
Email 
Samuel@bestat.com.tw 
 
 

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TABLE OF CONTENT 
AMENDMENT HISTORY ..................................................................................................................... 2 
INVESTIGATOR SIGNATURE PAGE .................................................................................................... 3 
SPONSOR SIGNATURE PAGE .............................................................................................................. 4 
CONTACT INFORMATION OF KEY ROLES ........................................................................................ 5 
TABLE OF CONTENT .......................................................................................................................... 7 
LIST OF ABBREVIATIONS .................................................................................................................. 8 
PROTOCOL SYNOPSIS......................................................................................................................... 9 
1. INTRODUCTION ......................................................................................................................... 11 
1.1. Background Information ................................................................................................. 11 
1.2. Study Rationale ................................................................................................................ 11 
2. RESEARCH OBJECTIVES ........................................................................................................... 12 
3. RESEARCH METHODS ............................................................................................................... 12 
3.1. Study Design ..................................................................................................................... 12 
3.2. Study Population and Sample Size ................................................................................. 12 
3.3. Study Sites ........................................................................................................................ 13 
3.4. Data Collection ................................................................................................................. 13 
3.5. Outcome Measures........................................................................................................... 15 
3.6. Subgroup analysis ............................................................................................................ 16 
4. STATISTICAL CONSIDERATIONS AND ANALYTICAL PLAN ................................................... 16 
4.1 Analysis Plan .................................................................................................................... 16 
4.2 Missing Data ..................................................................................................................... 16 
5. DATA HANDLING AND RECORD KEEPING .............................................................................. 16 
5.1 Data Management Responsibilities ................................................................................ 16 
5.2 Data Handling Conventions ............................................................................................. 17 
5.3 Data Capture Methods ..................................................................................................... 17 
5.4 Study Records Retention ................................................................................................. 17 
6. QUALITY CONTROL AND QUALITY ASSURANCE ................................................................... 18 
7. PROTECTION OF HUMAN SUBJECTS ....................................................................................... 18 
7.1. Ethical Approval and Subject Consent ........................................................................... 18 
7.2. Subject Confidentiality .................................................................................................... 18 
7.3. Protocol Amendments ..................................................................................................... 19 
8. PUBLICATION POLICY............................................................................................................... 19 
9. REFERENCES ............................................................................................................................. 20 
 

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LIST OF ABBREVIATIONS 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
DFU 
Diabetic Foot Ulcer 
DM 
Diabetes Mellitus 
EMR 
Electronic Medical Records 
HRQoL 
Health-Related Quality of Life 
ICF 
Informed Consent Form 
ICD-9-CM 
International Classification of diseases, 9th Revision with Clinical 
Modification 
ICD-10-CM 
International Classification of diseases, 10th Revision with Clinical 
Modification 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDF 
International Diabetes Federation 
IRB 
Institutional Review Board 
QoL 
Quality of Life 
UK 
United Kingdoms 
USA 
United States of America 
 
 

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PROTOCOL SYNOPSIS 
I. Protocol title: 
A retrospective record-review study in patients who had participated in the ON101CLCT02 
diabetic foot ulcer trial 
II. Objectives: 
To understand the life and financial burden of diabetic foot ulcers (DFUs) on patients, this 
study is proposed to retrospectively collect data on disease status and medical utilization 
in DFU patients through medical record review.  
III. Study procedures: 
⚫ 
Study population: The ON101CLCT02 trial enrolled 236 subjects and was conducted 
in Taiwan, China, and USA. The target population of this study consists of the Taiwanese 
DFU patients who had completed or early withdrawn from the ON101CLCT02 trial 
(188 of them). No additional inclusion or exclusion criteria will be applied. 
⚫ 
Study Sites: Seven (7) out of the 11 sites participated in the ON101CLCT02 trial, 
including Tri-Service General Hospital, China Medical University Hospital, Linkou 
Chang Gung Memorial Hospital, Kaohsiung Chang Gung Memorial Hospital, Chi Mei 
Medical Center, MacKay Memorial Hospital, National Taiwan University Hospital 
⚫ 
Study duration:  
◼ 
Review of medical records: Up to two years after the patient had completed or 
early withdrawn from the ON101CLCT02 trial 
IV. Data collection: 
The following data will be collected from the medical records: 
1. 
Weight and measurement date 
2. 
Blood pressure and measurement date 
3. 
Ankle-brachial index and measurement date 
4. 
Biochemical results (HbA1c, BUN, WBC, CRP, Creatinine) and measurement date 
5. 
DM complications (neuropathy, peripheral arterial disease, retinopathy, kidney 
disease) 
6. 
Undergoing dialysis or not, if so, hemodialysis or peritoneal dialysis 
7. 
For the healed target DFU in ON101CLCT02 trial, whether any recurrence, if so, the 
date 
8. 
Survival status and date of death, if applicable 
9. 
The number of DFU wounds and the size, severity, duration, location, etiology, etc of 
each wound 

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10. Medical utilization 
➢ 
The number of outpatient visits for DFUs and the use of medical resources each 
time 
➢ 
The number of hospitalizations due to DFUs and the length of stay, the use of 
medical resources in each hospitalization  
➢ 
The number of emergency visits for DFUs and the use of medical resources each 
time  
➢ 
Whether to use or perform other therapies or care for the treatment of diabetic 
foot (such as hyperbaric oxygen therapy, pressure wound therapy, debridement, 
etc.), if so, the frequency 
➢ 
The usage of medical consumables for DFUs, such as the size and number of 
gauzes 
11. Whether infection occurred, if so, number of times and date 
12. Whether there is gangrene, if so, number of times and date 
13. Whether there is amputation, if so, major or minor, the location, success or failure, date 
14. Whether there is any plastic or reconstructive surgery, such as skin grafts, flap surgery, 
etc., if so, the frequency, success or failure, and date  
V. Statistics: 
Continuous variables will be presented in mean, median, standard deviation, range 
(maximum, minimum), and 95% confidence interval and will be compared with T-test. 
Categorical variables will be presented in frequency and proportion. The Fisher’s exact test 
will be used to compare the differences between the categorical variables. Statistically 
significant is defined by two-tailed, p<0.05. The correlation of continuous variables will be 
analyzed by linear regression. 
 
The outcome measures include: 
1. 
Demographic characteristics 
2. 
Wound characteristics of DFUs (classification and proportion) 
3. 
Proportion of DFU recurrence after completing or withdrawing from the clinical trial 
ON101CLCT02 
4. 
Medical costs due to DFUs 
5. 
Proportion and frequency of wound infection, gangrene, and amputation 
 
Subgroup analyses include: 
1. 
The target ulcer has healed when completing or withdrew from the trial 
ON101CLCT02  
2. 
Baseline HbA1c >7% 
The medical cost of illness of DFUs may be assessed for the above subgroups. 

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1. INTRODUCTION 
1.1. Background Information 
According to current statistics from International Diabetes Federation (IDF), diabetes mellitus 
(DM) is on the rise all over the world. In 2017, it was predicted that 451 million people (aged 
18–99 years) globally had diabetes. The number is predicted to rise to 693 million by 2045 [1]. 
Diabetic foot ulcer (DFU) is a severe complication of DM, of which the lifetime incidence has 
been estimated to be 19 to 34% among DM patients [2]. The global prevalence of DFU was 
reported to be 6.3% [3], and the number in Taiwan between 2001 and 2015 was 0.5 to 0.8% 
[4].  
DFU can result in a heavy medical burden due to infections, as well as a reduction in quality of 
life (QoL) and an increase in mortality. More than half of DFUs are infected [5], and the 
amputation rate is approximately 2% among all DFU cases [6]. The health-related quality of life 
(HRQoL) was low in DFU patients, and the physical HRQoL was especially affected after 
amputation [7,8]. A patient with a DFU has a 2.5-fold higher risk of death at 5 years than a DM 
patient who does not have a foot ulcer [9]. 
The intensive medical care of DFU leads to drastic financial costs. In the USA, the annual 
healthcare cost per patient due to DFUs was about $15,000, and excess work-loss costs of about 
$3,000 were observed for private insured patients [10]. The medical expenditure of diabetes-
related ulceration and amputation was about £900 million per year in the UK, accounting for 
almost 1% of the National Health Service budget [11]. In China, the average cost per DFU patient 
was about ¥42,000 in 2020 and has increased about 2.7-fold in the past 6 years [12]. The mean 
annual medical cost for DFU treatment in Taiwan per patient were estimated to be around 
$4,700 USD [13]. Overall, DFU causes noticeable expenses on medical care around the globe as 
well as in Taiwan.  
1.2. Study Rationale  
Chen et al. has estimated the total cost of DFU with over 800,000 patients, and Tai et al. has 
analyzed the medical utilization of DFU, the percentage of debridement and amputation among 
DFU patients in Taiwan [4,13]. However, the information on DFU severity, number of wounds, 
duration, and lab data was inaccessible due to the lack of medical records in the previous 
studies. With available clinical data, a detailed analysis of medical expenditure on DFU can be 
conducted and further explore the correlations between the risk factors and medical costs.  

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The identification of cost-effective and cost-saving treatments that can assist minimize the DFU 
healthcare burden has been ongoing [14]. The efficacy of ON101 (Fespixon cream®) has been 
proven, but its impact on medical expenditure is yet to be determined. Therefore, to understand 
the preliminary result on the cost of illness after introducing ON101 as a DFU treatment, a 
retrospective study based on medical records is proposed to analyze whether there are 
differences between the costs of illness in DFU patients who used ON101 or Aquacel® in the 
ON101CLCT02 trial.  
2. RESEARCH OBJECTIVES 
The purpose of the study is to evaluate the medical cost of illness for DFUs on the patients who 
had used ON101 or Aquacel® in the ON101CLCT02 trial.  
3. RESEARCH METHODS 
3.1. Study Design  
This is a retrospective, multicenter, chart-review study. The study is designed to review the 
electronic medical records (EMR) of the patients who participated in the ON101CLCT02 trial. 
The EMR to be reviewed includes outpatient, inpatient, and emergency visits due to DFUs. 
Data from the date of the DFU patient completed or early withdrew from the ON101CLCT02 
trial up to two years after his/her completion or early withdrawal from the ON101CLCT02 trial 
are to be reviewed and collected. 
Additional phone interview will be conducted if some protocol specified information is missing 
in the patient’s EMR. 
3.2. Study Population and Sample Size 
The ON101CLCT02 trial enrolled 236 subjects and was conducted in Taiwan, China, and USA. 
The target population of this study consists of the Taiwanese DFU patients who had completed 
or early withdrawn from the ON101CLCT02 trial (188 of them). 
No additional inclusion or exclusion criteria will be applied. 

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3.3. Study Sites  
There were 11 sites that had participated in the ON101CLCT02 trial. This study will be 
conducted at 7 out of the 11 sites due to feasibility.  
List of sites: 
1. 
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital 
2. 
Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital 
3. 
China Medical University Hospital 
4. 
Chi Mei Medical Center 
5. 
MacKay Memorial Hospital  
6. 
National Taiwan University Hospital 
7. 
Tri-Service General Hospital 
3.4. Data Collection 
The following data will be collected from the EMR. Only the latest available data within the 
predefined data collection period, i.e., up to two years after the subject had completed or early 
withdrawn from the ON101CLCT02 trial will be recorded. The date of measurement or visit will 
be recorded too.  
Category 
Variable(s) 
Demographic 
Weight (unit: kg) 
Blood Pressure 
Systolic/Diastolic blood pressure (unit: mmHg) 
Ankle-brachial index (Left/Right; value) 
Biochemistry 
HbA1c (Glycated Hemoglobin A1c) (unit: %) 
BUN (Blood Urea Nitrogen) (unit: mg/dL) 
WBC (White Blood Cell) (unit: 103/mm3) 
CRP (C-Reactive protein) (unit: mg/dL) 
Creatinine (unit: mg/dL) 
Comorbidities 
DM complications (Yes; specify the diagnosis/No) 
Neuropathy/Peripheral vascular disease/Retinopathy/Kidney 
disease/Cardiovascular disease 
Dialysis (Yes; specify the interval/No) 
Hemodialysis/Peritoneal dialysis  
DFU Characteristics 
Number of DFUs 
Each DFU: 

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Location (Left/Right; Plantar/Non-plantar) 
Etiology (Neuropathy/Neuro-ischemia/Peripheral vascular 
disease/Other) 
Duration (month) 
Severity (Wagner grade 0-5) 
Area (mm2) 
Target ulcer of ON101CLCT02 trial (Yes/No) 
Other 
Survival (Yes/No) 
Date of death 
Status of the healed target ulcer of ON101CLCT02 trial  
Recurrence (Yes/No) and date of recurrence 
 
The following data will be collected from the EMR. All the available data within the predefined 
data collection period, i.e., up to two years after the subject had completed or early withdrawn 
from the ON101CLCT02 trial will be recorded. The date of measurement or visit will be 
recorded too. 
Category 
Variable(s) 
Management for 
Comorbidities 
DM complications (Yes; specify the diagnosis /No) 
Neuropathy/Peripheral vascular disease/Retinopathy/ 
Kidney disease/Cardiovascular disease 
Treatment or management received (e.g., medication use, 
therapy, surgery, etc.) for any of the above comorbidities and the 
date 
Medical Utilization 
Record all clinical visits with a diagnosis code of foot ulcers: 
ICD-9-CM code: 707.06, 707.07, 707.1, 892, and 893 
ICD-10-CM code: L89.509, L89.609, L97.909, S91.109A, 
S91.129A, S91.209A, S91.309A, S91.329A, S96.929A 
Whether the visits were due to the target ulcer in ON101CLCT02 
trial (Yes/No/Partial/Unknown) 
Number and date of outpatient visits  
Number and date of hospitalizations 
Stay length (day) 
Number and date of emergency visits 
Therapies or care of each visit: 
Offloading 
Comprehensive foot exam 
Change dressing 
Laboratory test 

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Imaging test 
Usage of medical consumables 
Gauzes (size, number) 
Others 
DFU Disease Status and 
Treatment 
Therapies or care for the treatment of diabetic foot (Yes/No) 
Hyperbaric oxygen therapy/Pressure wound therapy/Other 
Infection (Yes/No) 
Number of times  
Gangrene (Yes/No) 
Number of times 
Debridement (Yes/No) 
Number of times 
Amputation (Yes/No) 
Number of times 
Major/Minor 
Location 
Success/Failure 
Revascularization (Yes/No) 
Number of times 
Success/Failure 
Plastic or reconstructive surgery (Yes/No) 
Number of times 
Skin grafts/Flap surgery/Other 
Success/Failure 
 
Note: Please also record the medical utilization arise from the 
above condition as per “Medical Utilization” category. 
 
3.5. Outcome Measures 
1. 
Demographic characteristics 
2. 
Wound characteristics of DFUs (classification and proportion) 
3. 
Proportion of DFU recurrence after completing or withdrawing from the ON101CLCT02 
trial 
4. 
Medical costs due to DFUs 
5. 
Proportion and frequency of wound infection, gangrene, and amputation 

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3.6. Subgroup analysis 
The medical cost of illness due to DFUs may be assessed for the following subgroups: 
1. 
The target ulcer has healed when completing or withdrew from the trial ON101CLCT02  
2. 
Baseline HbA1c >7% 
4. STATISTICAL CONSIDERATIONS AND ANALYTICAL 
PLAN 
4.1 Analysis Plan 
The baseline demographic and clinical characteristics will be described using descriptive 
statistics. Continuous variables will be summarized using number of values (n), mean, standard 
deviation (SD), median, range (minimum and maximum) and 95% confidence interval (CI). 
Frequencies and percentages will be reported for all categorical data. 
Statistical analysis will be performed using T-test or Fisher’s exact. Statistically significant is 
defined by two-tailed, p <0.05. The correlation of continuous variables will be analyzed by linear 
regression, if applicable. 
The effectiveness of treatment of ON101 and Aquacel® will be estimated with the clinical 
outcomes using cost-effectiveness or cost-benefit analyses. The total cost for DFU and the 
incremental cost-effectiveness ratio will be calculated. 
4.2 Missing Data 
No imputation strategies will be implemented for missing data. 
5. DATA HANDLING AND RECORD KEEPING 
5.1 Data Management Responsibilities 
Data collection and accurate documentation are the responsibility of the study staff under the 
supervision of the Investigators. 
Oneness Biotech Co., Ltd. or its designee(s) will be responsible of data management and quality 

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review, analysis and report the study data. 
5.2 Data Handling Conventions 
Data will be extracted from the EMRs of the 11 study sites listed in Section 3.3. Data will be 
collected according to the following procedures by the Investigators or designees: 
1. 
Identify the subject who had completed or early withdrawn from ON101CLCT02 trial 
2. 
Enter clinical data from EMR to the CRF. 
3. 
Conduct phone interview with the subject if some information is missing in the EMR. Enter 
the information provided to the CRF. 
4. 
Verification of data by second personnel 
5. 
Remove patient personal identifiers (e.g., names, identification numbers, and medical 
record numbers) and send the de-identified data to the designated personnel for data 
management, validation, and analyses  
5.3 Data Capture Methods 
Data will be written to CRFs designed by Bestat Pharmaservices Corp. CRFs will be used for 
recording all data from each subject in this study. CRFs must be typewritten or printed legibly 
using black ballpoint pen or completed electronically. 
Data documented in the CRFs will be entered into the study database powered by Microsoft® 
Excel® by the Sponsor or designated personnel. Queries regarding the unclear data will be 
reviewed and be sent to the investigators for clarification. A data clarification form will be 
applied for the queries if necessary. Designated site staffs are required to reply to the queries 
and make any necessary changes to the data. The queries will be resolved, and corresponding 
updates will be made to the database if necessary. Once all queries have been resolved, the 
database will be locked. The locked data will be exported to generate the subject listings, 
tabulations, or statistical analyses. 
5.4 Study Records Retention 
Study documents should be retained for a minimum of 2 years after the completion of the study. 
These documents should be retained for a longer period, however, if required by local 
regulations. No records will be destroyed without the written consent of the Sponsor, if 

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applicable. It is the responsibility of the Sponsor to inform the Investigators when these 
documents no longer need to be retained. 
6. QUALITY CONTROL AND QUALITY ASSURANCE  
All aspects of data collection, management or analysis will be conducted according to the study 
protocol. Programming for this project will be conducted by a primary statistician and validated 
by a separate analyst. For all data processing steps, the validation analyst will review the 
program along with input and output data sets.  
7. PROTECTION OF HUMAN SUBJECTS 
7.1. Ethical Approval and Subject Consent 
The protocol and other study documents will be submitted to the IRB of each study site for 
review and approval. Approval of the protocol must be obtained before any data collection is 
initiated. Any amendment to the protocol will require review and approval by the IRB before 
the changes are implemented in the study. 
Patient’s consent is to be obtained prior to any procedures if deemed necessary by the IRB. Only 
an IRB-approved consent form is to be used. 
7.2. Subject Confidentiality 
Subject confidentiality is strictly held in trust by the participating Investigators, their staff, and 
the Sponsor and their agents. Patient-identified code will be used to improve patient privacy. 
The Investigators must assure that patients' privacy will be maintained and that their identities 
are protected from unauthorized parties. 
The study protocol, documentation, data, and all other information generated will be held in 
strict confidence. No information concerning the study or the data will be released to any 
unauthorized third party without prior written approval of the Sponsor. 
The study monitors or other authorized representatives of the Sponsor may inspect all 
documents and records required to be maintained by the Investigators, including but not 
limited to medical records (office, clinic, or hospital) and pharmacy records for the patients in 
this study. The study sites will permit access to such records. 

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7.3. Protocol Amendments 
Any change of this protocol that affect study objectives, study design, study procedures, patient 
population, or significant administrative procedures will require a formal amendment to the 
protocol. Any proposed protocol amendments must be sent in written form to the applicable 
IRB. Prior to implementation, an amendment must be approved by the Sponsor, the 
Investigator, and the applicable IRB. 
The same applies to the informed consent form. 
8. PUBLICATION POLICY 
Following completion of the study, the Investigators are expected to publish the results of this 
research in a scientific journal. Member journals of The International Committee of Medical 
Journal Editors (ICMJE) have adopted a trials-registration policy as a condition for publication. 
This policy requires that all clinical trials be registered in a public trials registry such as 
ClinicalTrials.gov, which is Sponsored by the National Library of Medicine. Other biomedical 
journals are considering adopting similar policies. For grants and cooperative agreements, it is 
the responsibility of Oneness Biotech Co., Ltd. to register the trial in an acceptable registry.  
The ICMJE defines a clinical trial as any research project that prospectively assigns human 
subjects to intervention or comparison groups to study the cause-and-effect relationship 
between a medical intervention and a health outcome. Studies designed for other purposes, 
such as to study pharmacokinetics or major toxicity (e.g., Phase I trials), would be exempt from 
registering trials in a public registry such as ClinicalTrials.gov. 
 
 
 

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