GROUP 7 - PROJECT-1

TABLE OF CONTENTS – CLINICAL STUDY REPORT (TOC-CSR)

RGA#6207 Global Impact of Electronic Common Technical Document (eCTD)
Submissions
RGA 6207 Global Impact of the eCTD

Professor Steve Kates

Biopharmaceutical Regulatory Affairs

College of Professional Studies Northeastern University

Submitting Author: Manpreet Singh

Group Members:
Arline Mendonca
Kajalben Davra
Sri Ranga Viswanath Kaley
Hiral Pansuriya
Shruthi Thadisina

COVER PAGE

Clinical study for Hydroxypropyline Idoxicide tablets.

PROTOCOL NUMBER: 65233

Investigational product: Hydroxypropyline Idoxicide tablets.

Manufacturer: Devine Pharmaceuticals
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Indication: Diabetes mellitus.

Study design: Randomized Controlled Trial
IND (Investigational New Drug) sponsor: Falcon Pharmaceuticals
Study Phase: Phase 3
Study start date: 11th November 2015
Study completion date: 14th November 2023
Principal investigator: Doctor John Wick
Report version number: 56780
Report date: 15th November 2023
The study was carried out in accordance with Good Clinical Practice as required by the
following items:
1. United States Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR
Part 46; 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312)
2. International Council for Harmonization guideline E6(R2): Good Clinical Practice:
Integrated Addendum to ICH E6(R1)

SIGNATURE PAGE:
Protocol Title: Clinical study of Hydroxypropyline Idoxicide tablets to notice the
Protocol Number: 65233
I, Doctor John Wick, have read this report and confirm to the best of my knowledge it accurately
describes the conduct and results of this study.

Principle Investigator:
Signature: John Wick Date: 15th November 2023

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Table of contents
1 Synopsis-......................................................................................................................................8
2 List of In-text Tables-.................................................................................................................9
Table 1.1- General information about clinical data................................................................9
Table 3.1- List of abbreviations used in the study..................................................................9
3 List of Abbreviations-.................................................................................................................9
4 Ethics-..........................................................................................................................................9
4.1 Institutional Review Board.................................................................................................9
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4.2 Ethical Conduct of the Study............................................................................................10

4.3 Participant Information and Consent..............................................................................10
5 Investigator’s Study Administrative Structure-....................................................................10
6 Introduction-.............................................................................................................................10
7 Objectives-.................................................................................................................................10
8. Investigational Plan-................................................................................................................10
8.1 Overall Study Design and Plan.........................................................................................10
8.1.1 Screening/Baseline Visit..............................................................................................10
8.1.2 Treatment Duration....................................................................................................10
8.1.3 Follow-Up.....................................................................................................................11
8.2 Discussion of Study Design (Including Changes in Study Design and choice of control
groups).......................................................................................................................................11
8.3 Selection of Study Population...........................................................................................11
8.3.1 Inclusion Criteria........................................................................................................11
8.3.1.1 Inclusion Criteria for all Participants-...............................................................11
8.3.2 Exclusion Criteria........................................................................................................11
8.3.2.1 Exclusion Criteria for all Participants................................................................11
8.3.3 Removal of Participants from Therapy or Assessment-..........................................11
8.4 Treatments..............................................................................................................................11
8.4.1 Treatments Administered...........................................................................................11
8.4.2 Investigational Product...............................................................................................11
8.4.3 Method of Assigning Participants to Dose Groups..................................................11
8.4.4 Selection of Doses in the Study...................................................................................11
8.4.5 Selection and Timing of Dose for Each Participant.................................................11
8.4.6 Blinding........................................................................................................................11
8.4.7 Prior and Concomitant Therapy................................................................................11
8.4.8 Treatment Compliance...............................................................................................12
8.5 Efficacy and Safety Variables...........................................................................................12
8.5.1 Efficacy Assessments...................................................................................................12
8.5.2 Safety Assessments......................................................................................................12
8.5.3 Other Assessments.......................................................................................................12
8.5.4 Appropriateness of Measurements............................................................................12

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8.5.5 Endpoints.....................................................................................................................12
8.5.5.1 Primary Endpoints...............................................................................................12
8.5.5.2 Secondary Endpoints............................................................................................12
8.5.6 Drug Concentration Measurements..........................................................................12
8.6 Data Quality Assurance.....................................................................................................12
8.7 Statistical Methods.................................................................................................................12
8.7.1 Statistical and Analytical Plans.....................................................................................12
8.7.2 Determination of Sample Size........................................................................................12
8.8 Changes in the Conduct of the Study or Planned Analyses...........................................12
9 Study Patients-..........................................................................................................................13
9.1 Disposition of Participants................................................................................................13
9.2 Protocol Deviations............................................................................................................13
10 Efficacy Evaluation-...............................................................................................................13
10.1 Data Sets Analyzed...........................................................................................................13
10.2 Demographic and Other Baseline Characteristics........................................................13
10.3 Measurements of Treatment Compliance......................................................................13
10.4 Efficacy Results and Tabulations of Individual Participant Data...............................13
10.4.1 Statistical/Analytical Issues......................................................................................13
10.4.1.1 Multicenter Studies-...............................................................................................13
10.4.1.2 Use of an “Efficacy Subset” of Participants.........................................................13
10.4.1.3 Active-Control Studies Intended to Show Equivalence......................................13
10.4.1.4 Examinations of Subgroups...................................................................................13
10.4.2 Tabulation of Individual Response Data.................................................................13
10.4.3 Drug Dose, Drug Concentration, and Relationships to Response........................14
10.4.4 Drug-Drug and Drug-Disease Interaction..............................................................14
10.4.5 By-Participant Displays............................................................................................14
10.4.6 Efficacy Conclusions.................................................................................................14
11 Safety Evaluation-...................................................................................................................14
11.1 Extent of Exposure...........................................................................................................14
11.2 Adverse Events.................................................................................................................14
11.2.1 Brief Summary of Adverse Events...........................................................................14
11.2.2 Display of Adverse Events........................................................................................14
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11.2.3 Analysis of Adverse Events.......................................................................................14

11.2.4 Listing of Adverse Events by Participant................................................................14
11.3 Deaths, Other Serious Adverse Events, and Other Significant Adverse Events........14
11.3.1 Listing of Deaths, Other Serious Adverse Events, and Other Significant Adverse
Events........................................................................................................................................14
11.3.1.1 Deaths...................................................................................................................14
11.3.1.2 Other Serious Adverse Events...........................................................................15
11.3.1.3 Other Significant Adverse Events.....................................................................15
11.3.2 Narratives of Deaths, Other Serious Adverse Events, and Certain Other
Significant Adverse Events..................................................................................................15
11.3.3 Analysis and Discussion of Deaths, Other Serious Adverse Events, and
Otherqq⁰Q¹Qqq Significant Adverse Events.....................................................................15
11.4 Clinical Laboratory Evaluation......................................................................................15
11.4.1 Listing of Individual Laboratory Measurements by Participant and Each
Abnormal Laboratory Value...............................................................................................15
11.4.2 Evaluation of Each Laboratory Parameter............................................................15
11.4.2.1 Laboratory Values Over Time..........................................................................15
11.4.2.2 Individual Participant Changes.........................................................................15
11.4.2.3 Individual Clinically Significant Abnormalities..............................................15
11.5 Vital Signs, Physical Findings, and Other Observations Related to Safety................15
11.6 Long Term Follow Up......................................................................................................15
11.6.1 Gene Transfer Studies...............................................................................................15
11.6.1.1 List of Individual Participant Replication Competent Retroviral/Lentiviral
Test Results........................................................................................................................15
11.7 Safety Conclusions...........................................................................................................15
12. Discussion and Overall Conclusion-.....................................................................................16
13. Tables, Figures, and Graphs-...............................................................................................16
13.1 Demographic Data Summary figures and tables..........................................................16
13.2 Efficacy Data Summary figures and tables...................................................................16
13.3 Safety Data Summary figures and tables.......................................................................16
13.3.1 Display of Adverse Events........................................................................................16
13.3.2 Listing of Deaths, Other Serious and Significant Adverse Events........................16
13.3.3 Narrative of Deaths, Other Serious and Significant Adverse Events...................16

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13.3.4 Abnormal Laboratory Value Listing (each participant).......................................16

13.3.5 Long Term Follow Up Test Results (Gene Transfer Studies)...............................16
14. References-.............................................................................................................................16
15. Appendices-............................................................................................................................16
15.1 Study Information............................................................................................................16
15.1.1 Protocol and protocol amendments including Informed Consent Forms............16
15.1.2 Sample case report form (unique pages only).........................................................16
15.1.3 List of IEC's or IRB's (plus the name of the committee chair if required by the
regulatory authority) and representative written information for Participant and
sample consent forms...........................................................................................................17
15.1.4 List and description of investigators and other important participants in the
study, including brief (one page) CV's or equivalent summaries of training and
experience relevant to the performance of the clinical study...........................................17
15.1.5 Signatures of principal or coordinating investigator(s) or sponsor's responsible
medical officer, depending on the regulatory authority's requirement..........................17
15.1.6 Listing of Participants receiving test drug(s)/investigational product(s) from
specific batches, where more than one batch was used-...................................................17
15.1.7 Randomization scheme and codes (Participant identification and treatment
assigned)................................................................................................................................17
15.1.8 Audit certificates (if available).................................................................................17
15.1.9 Documentation of statistical methods......................................................................17
15.1.10 Documentation of inter-laboratory standardization methods and quality
assurance procedures if used...............................................................................................17
15.1.11 Publications based on the study.............................................................................17
15.1.12 Important publications referenced in the report..................................................17
15.2 Participant Data Listings.................................................................................................17
15.2.1 Discontinued Participants.........................................................................................17
15.2.2 Protocol deviations....................................................................................................17
15.2.3 Participants excluded from the efficacy analysis....................................................18
15.2.4 Demographic data.....................................................................................................18
15.2.5 Compliance and/or drug concentration data (if available)...................................18
15.2.6 Individual efficacy response data.............................................................................18
15.2.7 Adverse event listings (each Participant)................................................................18

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15.2.8 Listing of individual laboratory measurements by Participant, when required by

regulatory authorities-.........................................................................................................18
15.3 Case Report Forms (CRF's)............................................................................................18
15.3.1 CRF's for deaths, other serious adverse events, and withdrawals for adverse
events.....................................................................................................................................18
15.3.2 Other CRF's submitted.............................................................................................18
15.4 Individual Participant Data Listings..............................................................................18

1 Synopsis-
Table 1.1- The following table describes the general information about the clinical study.
Name of IND Sponsor: (For National Authority
Falcon Pharmaceuticals Use Only)
Name of Final Product:
Hydroxypropyline
Idoxicide tablets.
Name of Active
Ingredient:

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Hydroxipropyline
Title of Study: Randomized trial of Hydroxipropyline to check its efficiency in
type 2 diabetes mellitus
Investigator and Study Site: Two sites were used.

Publication (reference): 1 publication, limited to drugs use or effectiveness.

Study Period (years): 8.5 years

Phase of Development: Clinical trials

Objectives: To choose safety of the participants over efficacy of the drug

Methodology: Randomization.

Number of Participants (planned and analyzed): 250 participants enrolled but

161 stayed till the end.

Diagnosis and Main Criteria for Inclusion: On the basis of age.

Inclusion Criteria for all Participants: Based on age.
Exclusion Criteria for all Participants: Any serious adverse reactions or medical
history prior to the trial.
Investigational Product(s), Dose and Mode of Administration, Manufacturer,
Batch Number: 8765

Changes in Manufacturing: No changes

Duration of Treatment: 3 to 4 months, depending upon the disease condition.

Reference Therapy, Dose, and Mode of Administration, Batch Number: 5645

Criteria for Evaluation: based on age

Efficacy Results: 66 percent in subjects having a prolonged disease situation

Safety Results: 95.56 percent safe in subjects having mild side effects, like fever
and nausea.

Conclusions: The study, calculating safety over efficacy ratio was successful

Date of the Report: 15th November 2023

2 List of In-text Tables-

These are as follows
Table 1.1- General information about clinical data.
Table 3.1- List of abbreviations used in the study.

3 List of Abbreviations-
Table 3.1- The following table includes the list of all abbreviations used in the study protocol.
Abbreviation Full form
AE Adverse Event
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CBC Complete Blood Count

CRF Case Report Form
CCR Center for Cancer Research
ECG Electrocardiogram
FDA Food and Drug Administration
IND Investigational New Drug Application

4 Ethics-
Ethics is very important for any trial.
4.1 Institutional Review Board
The protocol and any amendments were submitted for ethical review, and approval was obtained
in writing from each investigator’s Institutional Review Board (IRB). Any changes to the
protocol required IRB approval prior to implementation unless proceeding with the changes was
in the best interest of the Participant’s safety.
4.2 Ethical Conduct of the Study
This study was conducted in compliance with Good Clinical Practice and applicable Food and
Drug Administration (FDA) and other Department of Health and Human Services regulatory
requirements.
4.3 Participant Information and Consent
Informed consent was an ongoing process that began with the first contact with a prospective
participant and continued until the study was completed. The consent form provided information
about the study and what was involved in participating in the study, the risks, the benefits,
Participant rights, and documented the Participant's agreement to participate. All procedures,
Participant obligations, and Participant rights were explained to the Participant in easily
understood language.

5 Investigator’s Study Administrative Structure-

This section, which is primarily concerned with the study's administrative structure (e.g.,
principal investigator, coordinating investigator, steering committee, administration, monitoring
and evaluation committees, institutions, statistician, central laboratory facilities, contract
research organization (C.R.O.), clinical trial supply management), should be described briefly in
the report's body.
In the case of large trials with many investigators, the above information may be condensed to
general statements of qualifications for people performing specific roles in the study, with only
the name, degree, institutional affiliation, and roles of each investigator or other participant. The
list comprises investigators, any additional individual doing the observations, and the report's
author.

6 Introduction-
The randomized study of the drug Hydroxipropyline is going to change lives, hoping for a
remedy.
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7 Objectives-
Safety over efficacy is the primary objective of the study.

8. Investigational Plan-
8.1 Overall Study Design and Plan
8.1.1 Screening/Baseline Visit
Using accurate methodology, it was taken care of.
8.1.2 Treatment Duration
Varying from 3 to 4 months, based on the disease condition.
8.1.3 Follow-Up
8.2 Discussion of Study Design (Including Changes in Study Design and choice of control
groups)
Study design has thoroughly been worked upon.
8.3 Selection of Study Population
8.3.1 Inclusion Criteria
8.3.1.1 Inclusion Criteria for all Participants-
Based on age and medical history.
8.3.2 Exclusion Criteria
8.3.2.1 Exclusion Criteria for all Participants

No Participant could participate in the study if they didn’t meet our criteria.
8.3.3 Removal of Participants from Therapy or Assessment-

A Participant may have withdrawn or been withdrawn from the study for the following reasons:
If a Participant withdrew or was withdrawn prior to completion of the study, the reason for this
decision was recorded in the case report forms (CRFs). The remaining follow-up safety
evaluations were conducted if the Participant agreed. If a Participant was withdrawn because of
an AE or SAE (serious adverse events), the Participant was followed until resolution of the
event. The National Institutes of Health reserved the right to terminate this study at any time.

8.4 Treatments
8.4.1 Treatments Administered

161 out of 250 subjects were given treatments.

8.4.2 Investigational Product
8.4.3 Method of Assigning Participants to Dose Groups
Age and disease condition both were chosen while deciding the dose.

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8.4.4 Selection of Doses in the Study

Lower minimal dose to higher effective until the end of the study.
8.4.5 Selection and Timing of Dose for Each Participant
Two to three doses per day, depending upon the state of the disease and age.
8.4.6 Blinding
8.4.7 Prior and Concomitant Therapy
These therapies were well planned, and we had seen no issues relevant to any drug-drug
interactions.
8.4.8 Treatment Compliance
While treating the patients we followed the FDA guidelines, and documented the results side by
side, dose per dose, and patient by patient, on a daily basis.
8.5 Efficacy and Safety Variables
Safety was always prioritized, and exploration of efficacious doses was based on the
maintenance of the safety profile.
8.5.1 Efficacy Assessments
It was done by inclining the dosage every 4th or 5th day, to maintain the safety profile.
8.5.2 Safety Assessments
Safety assessment was done on daily basis, while providing the dose to individuals.
8.5.3 Other Assessments
There were no other assessments.
8.5.4 Appropriateness of Measurements
All efficacy and safety measurements were standard, reliable, and widely recognized as
appropriate.
8.5.5 Endpoints
8.5.5.1 Primary Endpoints
These were noticed based on 10 to 20 % declined sugar levels.
8.5.5.2 Secondary Endpoints
These were decided as the sugar levels declined by 50 %.
8.5.6 Drug Concentration Measurements
It was done each time before beginning the trial.
8.6 Data Quality Assurance
All source documents were completed by the clinician (or other appropriate study personnel).
Data were handled in accordance with Good Clinical Practice, federal regulations, and
instructions from CCR.

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8.7 Statistical Methods.

8.7.1 Statistical and Analytical Plans.
These plans were conducted by the whole team employed for the clinical trials.
8.7.2 Determination of Sample Size
It was based on participants from various groups chosen randomly to balance all the groups with
respect to diversity and count.
8.8 Changes in the Conduct of the Study or Planned Analyses
The original IRB-approved protocol was dated 20th June 2016. There were no amendments.

9 Study Patients-
9.1 Disposition of Participants
Nil
9.2 Protocol Deviations
Nil.

10 Efficacy Evaluation-
It was based on positive results throughout the period of a planned study cycle in every group,
varying in time from 3 to 4 months.
10.1 Data Sets Analyzed
A total of 20 sets were analyzed.
10.2 Demographic and Other Baseline Characteristics.
The response of drug had varied almost to a negligible degree with respect to demographic
characteristics.
10.3 Measurements of Treatment Compliance
Treatment plan was decided according to the FDA guidelines.
10.4 Efficacy Results and Tabulations of Individual Participant Data.
10.4.1 Statistical/Analytical Issues
There were a few statistical issues, which have been documented, before amending any
procedure or any faulty apparatuses.
10.4.1.1 Multicenter Studies-
The studies were conducted in two centers, and have they been documented accordingly, but
following a single treatment plan.
10.4.1.2 Use of an “Efficacy Subset” of Participants.
It was planned considering the candidates from various groups showing better response to the
drug in the first month.

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10.4.1.3 Active-Control Studies Intended to Show Equivalence.

10.4.1.4 Examinations of Subgroups.
All source documents were filled out completely by the examining personnel or the study
coordinator and signed by the person collecting the data on that form.
10.4.2 Tabulation of Individual Response Data.
The source documents were reviewed, signed, and dated by the investigator.
10.4.3 Drug Dose, Drug Concentration, and Relationships to Response.
10.4.4 Drug-Drug and Drug-Disease Interaction.

Reasons for this in the study may have included, Incidence or severity of AEs indicated a
potential health hazard; Data recording yet was accurate and complete; Investigator did adhere to
the protocol or applicable regulatory guidelines in conducting the study.
10.4.5 By-Participant Displays.
Included in the study report.
10.4.6 Efficacy Conclusions.
Included in the study report.

11 Safety Evaluation-
Included in the study report
11.1 Extent of Exposure
Included in the study report
11.2 Adverse Events
Included in the study report
11.2.1 Brief Summary of Adverse Events
Included in the study report
11.2.2 Display of Adverse Events
Included in the study report
11.2.3 Analysis of Adverse Events
Included in the study report
11.2.4 Listing of Adverse Events by Participant
Included in the study report

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11.3 Deaths, Other Serious Adverse Events, and Other Significant Adverse Events
11.3.1 Listing of Deaths, Other Serious Adverse Events, and Other Significant
Adverse Events
During the explanation of the study and during the actual study, the Participant was entitled to
privacy and respect. The investigator or a designer presented the information and administered
the consent. This person understood the protocol and was able to answer questions about the
investigational agent(s). The investigator/designee presenting the study encouraged the
prospective Participant to ask questions during this introduction to the study and anytime during
his/her participation.
11.3.1.1 Deaths
Nil
11.3.1.2 Other Serious Adverse Events
Nil
11.3.1.3 Other Significant Adverse Events
Nil
11.3.2 Narratives of Deaths, Other Serious Adverse Events, and Certain Other Significant
Adverse Events
Was added with proper explanation.
11.3.3 Analysis and Discussion of Deaths, Other Serious Adverse Events, and
Otherqq⁰Q¹Qqq Significant Adverse Events
Nil
11.4 Clinical Laboratory Evaluation
11.4.1 Listing of Individual Laboratory Measurements by Participant and Each Abnormal
Laboratory Value
It was done on a regular basis.
11.4.2 Evaluation of Each Laboratory Parameter
A record has been maintained throughout the trial on a daily basis.
11.4.2.1 Laboratory Values Over Time
Laboratory values were checked on a daily basis in both locations.
11.4.2.2 Individual Participant Changes.
It occurred only once during the study.
11.4.2.3 Individual Clinically Significant Abnormalities.
5 times in total were clinically significant abnormalities noticed and rectified.
11.5 Vital Signs, Physical Findings, and Other Observations Related to Safety.
Nil

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11.6 Long Term Follow Up

Nil
11.6.1 Gene Transfer Studies
11.6.1.1 List of Individual Participant Replication Competent Retroviral/Lentiviral Test
Results.
All those results were negative.
11.7 Safety Conclusions
Safety was never compromised during the trial.

12. Discussion and Overall Conclusion-

During the explanation of the study and during the actual study, the Participant was entitled to
privacy and respect. The investigator or a designer presented the information and administered
the consent. This person understood the protocol and was able to answer questions about the
investigational agent(s). The investigator/designee presenting the study encouraged the
prospective Participant to ask questions during this introduction to the study and anytime during
his/her participation.

13. Tables, Figures, and Graphs-

13.1 Demographic Data Summary figures and tables.
These have been included.
13.2 Efficacy Data Summary figures and tables.
They have been added with references and clarification to what study part the table or a figure
belongs to.
13.3 Safety Data Summary figures and tables.
They have added with references and clarification of the part of the study they belong to.
13.3.1 Display of Adverse Events.
Adverse events are noticed and noted on a usual basis.
13.3.2 Listing of Deaths, Other Serious and Significant Adverse Events.
No deaths were encountered during the trial.
13.3.3 Narrative of Deaths, Other Serious and Significant Adverse Events.
No deaths were encountered during the trial.
13.3.4 Abnormal Laboratory Value Listing (each participant)
Noted regularly
13.3.5 Long Term Follow Up Test Results (Gene Transfer Studies)
Nil

14. References-

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All the references are clearly mentioned with intext citations in particular paragraphs.

15. Appendices-
15.1 Study Information
Study information is available for all phases of clinical trials in eCTD.
15.1.1 Protocol and protocol amendments including Informed Consent Forms
Protocol and informed consent were taken care of before the study.
15.1.2 Sample case report form (unique pages only)
None.
15.1.3 List of IEC's or IRB's (plus the name of the committee chair if required by the
regulatory authority) and representative written information for Participant and sample
consent forms
All IEC’s and IRB’s individuals are included.
15.1.4 List and description of investigators and other important participants in the study,
including brief (one page) CV's or equivalent summaries of training and experience
relevant to the performance of the clinical study
Investigators' information is available in the document.
15.1.5 Signatures of principal or coordinating investigator(s) or sponsor's responsible
medical officer, depending on the regulatory authority's requirement
Doctor John Wick.
15.1.6 Listing of Participants receiving test drug(s)/investigational product(s) from specific
batches, where more than one batch was used-
It includes Harrison Ford, Twinkler Twide, Betulin Brigg, Gijoliy Hohu, Inioaba Frustrate, Babti
Bumbambu, Dinolin Foldull, Hihuhaha Hennhenn.
15.1.7 Randomization scheme and codes (Participant identification and treatment assigned)
Individual codes bringing together names and numbers were created to avoid bias.
15.1.8 Audit certificates (if available).
Nil
15.1.9 Documentation of statistical methods.
These are created and included in the clinical data profile.
15.1.10 Documentation of inter-laboratory standardization methods and quality assurance
procedures if used.
Nil. No inter-laboratories were used.
15.1.11 Publications based on the study.
A publication has been posted, but limited to usage or indications, focused upon the performance
of methods.

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15.1.12 Important publications referenced in the report.

NIL
15.2 Participant Data Listings
It has been included in the report
15.2.1 Discontinued Participants.
A total of 89 participants discontinued the trial
15.2.2 Protocol deviations.
Nil
15.2.3 Participants excluded from the efficacy analysis.
Nil
15.2.4 Demographic data.
It has been included.
15.2.5 Compliance and/or drug concentration data (if available).
Nil
15.2.6 Individual efficacy response data.
It has been collected and included, from both the locations.
15.2.7 Adverse event listings (each Participant).
There were 10 individuals with minor adverse events and 1 with serious adverse events.
Data has been included.
15.2.8 Listing of individual laboratory measurements by Participant, when required by
regulatory authorities-
It would be provided within a week when demanded.
15.3 Case Report Forms (CRF's)
15.3.1 CRF's for deaths, other serious adverse events, and withdrawals for adverse events
One CRF was taken for a serious adverse event and 88 CRF’s for withdrawals.
15.3.2 Other CRF's submitted.
NO other CRF’s were needed.
15.4 Individual Participant Data Listings
Was taken care of at the time when needed.

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