Detoxification From the Lipid Tract by Cocktail Design
Phase: PHASE4
Conditions: COVID-19 Vaccine Adverse Reaction
Sponsor: Pachankis, Yang I., M.D.

Detoxification from the Lipid Tract by Cocktail Design 
Study Protocol with Informed Consent Form 
 
National Clinical Trial (NCT) Identified Number:   
Principal Investigator: Yang I. Cao 
Sponsor: Scientifique Global Limited 
Protocol ID: SCI-CT-0001 
Funded by: Scientifique Global Limited 
Version Number:  v.<1.0> 
<07 March 2024> 
 
 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
 
 
 
 

  
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Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................ 1 
INVESTIGATOR’S SIGNATURE ............................................................................................................................. 1 
INFORMED CONSENT ............................................................................................................................................. 2 
1 
PROTOCOL SUMMARY .............................................................................................................................. 3 
1.1 
Synopsis ............................................................................................................................................... 3 
1.2 
Schema ................................................................................................................................................ 3 
1.3 
Schedule of Activities (SoA) .............................................................................................................. 5 
2 
INTRODUCTION ........................................................................................................................................... 5 
2.1 
Study Rationale ................................................................................................................................... 5 
2.2 
Background ............................................................................................ Error! Bookmark not defined. 
2.3 
Risk/Benefit Assessment ................................................................................................................... 5 
2.3.1 
Known Potential Risks .................................................................................................... 5 
2.3.2 
Known Potential Benefits ............................................................................................... 6 
2.3.3 
Assessment of Potential Risks and Benefits ............................................................... 6 
3 
OBJECTIVES AND ENDPOINTS ............................................................................................................... 6 
4 
STUDY DESIGN ............................................................................................................................................ 7 
4.1 
Overall Design ..................................................................................................................................... 7 
4.2 
Scientific Rationale for Study Design ............................................................................................... 7 
4.3 
Justification for Dose .......................................................................................................................... 7 
4.4 
End of Study Definition ....................................................................................................................... 7 
5 
STUDY POPULATION .................................................................................................................................. 7 
5.1 
Inclusion Criteria ................................................................................................................................. 7 
5.2 
Exclusion Criteria ................................................................................................................................ 8 
5.3 
Lifestyle Considerations ..................................................................................................................... 8 
5.4 
Screen Failures ................................................................................................................................... 8 
5.5 
Strategies for Recruitment and Retention ....................................................................................... 8 
6 
STUDY INTERVENTION .............................................................................................................................. 8 
6.1 
Study Intervention(s) Administration ................................................................................................ 8 
6.1.1 
Study Intervention Description ...................................................................................... 8 
6.1.2 
Dosing and Administration ............................................................................................. 8 
6.2 
Preparation/Handling/Storage/Accountability ................................................................................. 8 
6.2.1 
Acquisition and accountability ....................................................................................... 9 
6.2.2 
Formulation, Appearance, Packaging, and Labeling ................................................. 9 
6.2.3 
Product Storage and Stability ........................................................................................ 9 
6.2.4 
Preparation ....................................................................................................................... 9 
6.3 
Measures to Minimize Bias: Randomization and Blinding ............................................................ 9 
6.4 
Study Intervention Compliance ......................................................................................................... 9 
6.5 
Concomitant Therapy ......................................................................................................................... 9 
6.5.1 
Rescue Medicine ............................................................................................................. 9 
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ..................................................................................................................... 9 
7.1 
Discontinuation of Study Intervention .............................................................................................. 9 
7.2 
Participant Discontinuation/Withdrawal from the Study ................................................................ 9 
7.3 
Lost to Follow-Up .............................................................................................................................. 10 
8 
STUDY ASSESSMENTS AND PROCEDURES ..................................................................................... 10 
8.1 
Efficacy Assessments ...................................................................................................................... 10 

  
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8.2 
Safety and Other Assessments ...................................................................................................... 11 
8.3 
Adverse Events and Serious Adverse Events .............................................................................. 11 
8.3.1 
Definition of Adverse Events (AE) ............................................................................... 11 
8.3.2 
Definition of Serious Adverse Events (SAE) ............................................................. 11 
8.3.3 
Classification of an Adverse Event ............................................................................. 11 
8.3.4 
Time Period and Frequency for Event Assessment and Follow-Up ...................... 12 
8.3.5 
Adverse Event Reporting ............................................................................................. 13 
8.3.6 
Serious Adverse Event Reporting ............................................................................... 13 
8.3.7 
Reporting Events to Participants ................................................................................. 13 
8.3.8 
Events of Special Interest ............................................................................................ 13 
8.3.9 
Reporting of Pregnancy ................................................................................................ 13 
8.4 
Unanticipated Problems ................................................................................................................... 14 
8.4.1 
Definition of Unanticipated Problems (UP) ................................................................ 14 
8.4.2 
Unanticipated Problem Reporting ............................................................................... 14 
8.4.3 
Reporting Unanticipated Problems to Participants ................................................... 14 
9 
STATISTICAL CONSIDERATIONS .............................................................. Error! Bookmark not defined. 
9.1 
Statistical Hypotheses .......................................................................... Error! Bookmark not defined. 
9.2 
Sample Size Determination ................................................................. Error! Bookmark not defined. 
9.3 
Populations for Analyses ..................................................................... Error! Bookmark not defined. 
9.4 
Statistical Analyses ............................................................................... Error! Bookmark not defined. 
9.4.1 
General Approach ............................................................. Error! Bookmark not defined. 
9.4.2 
Analysis of the Primary Efficacy Endpoint(s) ................ Error! Bookmark not defined. 
9.4.3 
Analysis of the Secondary Endpoint(s) .......................... Error! Bookmark not defined. 
9.4.4 
Safety Analyses ................................................................. Error! Bookmark not defined. 
9.4.5 
Baseline Descriptive Statistics ........................................ Error! Bookmark not defined. 
9.4.6 
Planned Interim Analyses ................................................ Error! Bookmark not defined. 
9.4.7 
Sub-Group Analyses ......................................................... Error! Bookmark not defined. 
9.4.8 
Tabulation of Individual participant Data ........................ Error! Bookmark not defined. 
9.4.9 
Exploratory Analyses ........................................................ Error! Bookmark not defined. 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 14 
10.1 
Regulatory, Ethical, and Study Oversight Considerations .......................................................... 14 
10.1.1 
Informed Consent Process .......................................................................................... 14 
10.1.2 
Study Discontinuation and Closure ............................................................................. 15 
10.1.3 
Confidentiality and Privacy ........................................................................................... 15 
10.1.4 
Future Use of Stored Specimens and Data ............................................................... 16 
10.1.5 
Key Roles and Study Governance .............................................................................. 16 
10.1.6 
Safety Oversight ............................................................................................................ 16 
10.1.7 
Clinical Monitoring ......................................................................................................... 16 
10.1.8 
Quality Assurance and Quality Control ...................................................................... 17 
10.1.9 
Data Handling and Record Keeping ........................................................................... 17 
10.1.10 
Protocol Deviations ....................................................................................................... 18 
10.1.11 
Publication and Data Sharing Policy .......................................................................... 18 
10.1.12 
Conflict of Interest Policy .............................................................................................. 18 
10.2 
Additional Considerations ................................................................................................................ 18 
10.3 
Abbreviations ..................................................................................................................................... 19 
10.4 
Protocol Amendment History ........................................................................................................... 20 
11 
REFERENCES ............................................................................................................................................. 20 

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STATEMENT OF COMPLIANCE 
 
The trial will be carried out in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) and the following: 
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR 
Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both 
the protocol and the consent form must be obtained before any participant is enrolled.  Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
INVESTIGATOR’S SIGNATURE 
The signature below constitutes the approval of this protocol and provides the necessary 
assurances that this study will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory 
requirements and applicable US federal regulations and ICH guidelines, as described in the 
Statement of Compliance above. 
 
Principal Investigator or Clinical Site Investigator: 
 
Signed: 
 
 
Date: 
 
March 7, 2024 
 
Name:  Yang Cao 
 
Title: 
Principal Investigator (PI) 
 
Investigator Contact Information 
Affiliation: Scientifique Global Limited 
Address: Room 1508, 15/F., Office Tower Two, Grand Plaza, 625 Nathan Road, Kowloon, Hong Kong 
Telephone: +86 189 1056 6992 
Email: ypach@yangpachankis.us 
 
 

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INFORMED CONSENT 
The signature below constitutes the approval of this protocol and provides the necessary 
assurances that this study will be conducted according to all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory 
requirements and applicable US federal regulations and ICH guidelines, as described in the 
Statement of Compliance. 
 
Participant(s): 
 
Signed: 
 
 
Date: 
 
March 7, 2024 
 
Name:  Yang I. Pachankis 
 
Participant Contact Information 
Affiliation: Scientifique Global Limited 
Address: 2-28-4 Dexinyuan, 1001 Biqing N Rd, Chongqing 402762 
Telephone: +86 189 1056 6992 
Email: yang.pachankis@gmail.com 
 
 
 

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PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
Detoxification from the Lipid Tract by Cocktail Design 
Study Description: 
Apart from electroencephalogram biofeedback (EB) and electrical brain 
stimulation (EBS) adopted for maintenance treatment, the study utilizes 
infralow-frequency transcranial magnetic stimulation (ILF-TMS) for initial 
γ-aminobutyric acid (GABA) stimulation. The cocktail therapy starts after 
the primary efficacy endpoint, and concomitant therapy is adopted 
throughout the study. 
Objectives: 
 
Primary Objective: The primary objective is to detoxicate the substances 
leading to the adverse reactions after COVID-19 infection. 
 
Secondary Objectives: The secondary objective is to study the GABA’s 
effects in autism spectrum disorder (ASD). 
Endpoints: 
Primary Endpoint: Mar. 6, 2024 
Secondary Endpoints: Apr. 26, 2024 
Study Population: 
The study takes place in Chongqing, mainland China, without specification 
on gender or age. The population is mostly consisted of ethnic Chinese of 
the Han ethnicity. The individuals to be recruited are COVID-19-
vaccinated. Sample size not specified, and recruitment on a rolling basis. 
Phase: 
IV. 
Description of 
Sites/Facilities 
Enrolling Participants: 
The site is located in Chongqing, mainland China in a residence place.   
Description of Study 
Intervention: 
The primary efficacy endpoint mainly adopts device interventions with EB, 
EBS, and ILF-TMS for GABA. Afterwards, the cocktail therapy adopts 
alprazolam, pravastatin sodium, and metoprolol. 
Study Duration: 
2 months. 
Participant Duration: 
1 month. 
Intervention Duration: 
2 months. 
 
 
 
1.2 
SCHEMA 

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Day 1 - 9 
Primary Endpoint 
Day 10 - 17 
Secondary Endpoint 
   Day 18 - 24 
Follow-up 
Pre-enrollment 
Day -3 - 0 

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1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
Procedures 
Pre-Enrollment 
Day -3 - 0 
Primary Efficacy 
Day 1 - 9 
Secondary Efficacy 
Day 10 - 17 
Follow-up 
Day 18 - 24 
Informed consent 
X 
 
 
 
Demographics 
X 
 
 
 
Medical history 
X 
 
 
 
Administer study intervention 
 
X 
X 
X 
Administer device-based intervention 
 
X 
 
 
Concomitant medication review 
 
X 
 
 
Vital signs 
X 
X 
X 
X 
Performance status 
X 
X 
X 
X 
Hematology and other tests 
 
X 
X 
 
Adverse event review and evaluation 
X 
X 
X 
X 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY BACKGROUND 
 
Membrane fusion is established to be a critical mechanism of SARS-CoV viruses’ entry into the lipid 
bilayers of the cells 1. Not only correlative studies suggested that the changes in high-density lipoprotein 
– cholesterol (HDL-C) and low-density lipoprotein - cholesterol (HDL-C) influence on the severity of 
COVID-19 prognosis in patients2, the evidence also exists in macropinocytosis and steroidogenesis 
pathways for neuronal infections to precede cytokine storms, bypassing the blood-brain barrier (BBB) by 
lipid circulation 3,4. 
 
It was tested that GABA, in the joint action with topiramate, modulates macrophage activities by 
modulating cholesterol-metabolism associated molecules 5. GABA A receptors exhibit highly dynamic 
trafficking and cell surface mobility and influence on post-endocytic effects 6. Benzodiazepines (BZDs) 
exercise the mechanism of action by facilitating the binding of the inhibitory neurotransmitter GABA at 
various GABA receptors throughout the central nervous system (CNS) 7,8. Alprazolam, a type of BZD, was 
tested by Al-Tubuly, Aburawi, Alghzewi, Gorash and Errwami 9 in joint action with water-soluble beta 
blocker atenolol, in comparison with the non-selective β-adrenoceptor antagonist propranolol on the 
pharmacological effects on depression. The study hypothesizes that by replacing the water-soluble beta 
blocker to lipid-soluble one metoprolol, the effect of detoxification from the lipid and sebaceous 
immunobiological pathways can be achieved by the clathrin-dependent endocytosis process 6,10,11. 
 
2.2 
SCIENTIFIC RATIONALE 
 
Even though partial progress was made in the NCT05839236 trial by statin therapies, the therapeutic 
effects have not been lasting nor significant. The study develops from the previous protocol for a 
cocktail therapy by the joint mechanism of actions of alprazolam, metoprolol, and pravastatin sodium 
for the detoxification process. 
 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  

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The cocktail therapy may cause low heart rate, and consequentially induce sudden death during sleep by 
insufficient supply of blood and oxygen. 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
The cocktail therapy may reduce the risks in atherosclerosis from post-COVID-vaccine complexities, and 
potentially cure the high blood pressure in the context. Preventive effects may be exercised on the 
SARS-CoV viruses from the lipid upstream infection paths, including steroidogenesis, which bypass the 
BBB, and from further proliferation in the neuronal infections.  
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS  
The anti-depressant effects of alprazolam are mainly derived from its mechanism of action in releasing 
norephedrine, and in turn stimulate β2 receptors. The experiment trial of Al-Tubuly, Aburawi, Alghzewi, 
Gorash and Errwami 9 adopted water-soluble beta blocker that has anti-depressant effects to potentiate 
the anti-depressant effects of alprazolam. It differs from prazosin, which blocks or suppresses β1 
receptors in order to stimulate β2 receptors, that produces depression but substantially potentiate the 
anti-depressant effects of alprazolam and imipramine 9. 
 
In assessment of the purpose of the study alone, the main medicine of prazosin seems to have lower 
risks, higher risks arise from the potential side-effects of low blood pressure and heart failure. 
Moreover, with the participant’s ASD, the inhibition of β1 receptors may suppress respiration reflex, 
substantially increase the risks of sudden death during sleep. With the overall assessments, the cocktail 
therapy is finalized with alprazolam, pravastatin sodium, and metoprolol. 
 
3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
 
 
Degenerate lipids via statin 
therapy and lipid-soluble beta 
blocker by the aid of 
alprazolam. 
 
The pre-trial examinations 
suggest that brain 
excitation is insufficient 
and intercranial 
suppression is strong. 
GABA therapies with ILF-
TMS is adopted before the 
cocktail therapy. 
 
The excitation effects of clonazepam 
on the participant with ASD have 
been preparing the participant’s 
neuronal excitability for the cocktail 
therapy 12. 
Secondary 
 
 
Understand GABA therapy’s 
mechanism of action in ASD 
persons. 
 
Clonazepam is continuously 
used during the cocktail 
therapy, and the 
participant’s mode changes 
during the secondary 
endpoint will lead to 
further understandings. 
 
The correlative uses of 
benzodiazepines (alprazolam) and 
GABA-A receptor agonist 
(clonazepam) will reveal the 
mechanisms of action’s potentials in 
detoxification with the qualitative 
study. 
 
Tertiary/Exploratory  
 
 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
If the detoxification were 
successful, can the cocktail 
therapy be generalizable to 
wider population regardless of 
neurodiversity? If not, what are 
the missing links in the study 
design and the experiment 
trial? 
The exploratory objectives 
depend upon the result of 
the secondary efficacy 
endpoint. 
Causal inference in the correlations 
between neuronal activities and 
metabolism will further our 
understandings in sebaceous 
immunobiology. 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
The study is designed to utilize both the metabolic tract of lipid degeneration by statin therapy and the 
neuronal tract of lipid degeneration, where alprazolam increases level of oxidative degradation of lipids 
13. The study design framework is predicted to ameliorate oxidative stress in the metabolic symptoms, 
while inducing the SARS-CoV viral excretion from the lipid bilayers of cells 1. 
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
The phenyl rings and methyl groups are biochemically affined to GABA interactions, intermediated by 
the van der Waals radii 14. It is then inferred that the van der Waals force’s difference exists in autistic 
and neurotypical GABA receptor binding activities, explaining the mechanism of actions of clonazepam 
in excitation for ASD users 12 . The chemical structural similarities of clonazepam and alprazolam in the 
different effects exercised on ASD users can be exploratorily revealed by the lipid degenerative design in 
the study, i.e., intervention in the upstream steroidogenesis tract 15. 
 
4.3 
JUSTIFICATION FOR DOSE 
All medicines start with the minimum dosage labelled and adjusted according to symptom amelioration 
and development. No exceeding dosage is intended unless the efficacy is proven, adverse event 
minimized, and necessities justified for intensive treatment. 
 
4.4 
END OF STUDY DEFINITION 
A participant is considered to have completed the study if he or she has completed all phases of the study 
including the last visit or the last scheduled procedure shown in the Schedule of Activities (SoA), Section 
1.3. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
In order to be eligible to participate in this study, an individual must meet all of the following criteria: 
1. Provision of signed and dated informed consent form 
2. Stated willingness to comply with all study procedures and availability for the duration of the 
study  
3. Above the age for consent 
4. Have been SARS-CoV-2 vaccinated 

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5. Ability to take oral medication and device-enabled therapies, and be willing to adhere to the 
Detoxification from the Lipid Tract regimen 
6. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study duration] 
 
5.2 
EXCLUSION CRITERIA 
1. Below the age of 18 when entering the trial; 
2. Healthy participants without COVID-19 vaccination. 
 
5.3 
LIFESTYLE CONSIDERATIONS 
During this study, participants are asked to: 
• 
Abstain from alcohol for the whole interventional trial. 
• 
Abstain from strenuous exercise for the whole interventional trial.  
 
5.4 
SCREEN FAILURES 
Screen failures are defined as participants who consent to participate in the clinical trial but are not 
subsequently randomly assigned to the study intervention or entered in the study. 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
With the systematic official denials on the post-vaccination conditions, only participants who have trust 
in the PI and have doubt in the vaccination methods in SARS-CoV-2 during initial contact are considered 
for recruitment. 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION(S) ADMINISTRATION 
 
6.1.1 STUDY INTERVENTION DESCRIPTION 
 
Intervention 
Method 
Dosage 
Time 
Period 
Concomitant 
EB 
Device 
Twice 
Per day 
Primary 
No 
EBS 
Device 
Once 
Per day 
ILF-TMS 
Device 
Once 
Per day 
Alprazolam 
Oral 
0.4 mg 
Per night 
Starting at the 
end of primary 
Yes 
Clonazepam 
Oral 
1 mg 
Per day 
Metoprolol 
Oral 
95 mg 
Per night 
Secondary 
Yes 
Pravastatin Sodium 
Oral 
20 mg 
Per night 
Sertraline Hydrochloride 
Oral 
150 mg 
Per day 
Throughout 
No 
Olanzapine 
Oral 
10 mg 
Per night 
 
6.1.2 DOSING AND ADMINISTRATION 
See in Section 6.1.1. 
 
6.2 
PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 

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6.2.1 ACQUISITION AND ACCOUNTABILITY 
Not applicable. 
 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
Not applicable. 
 
6.2.3 PRODUCT STORAGE AND STABILITY 
Not applicable. 
 
6.2.4 PREPARATION 
Not applicable. 
 
6.3 
MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
Not applicable. 
 
6.4 
STUDY INTERVENTION COMPLIANCE 
Daily records are kept by the nurses, investigator and / or participant. 
 
6.5 
CONCOMITANT THERAPY 
Iodized lecithin 4.5 mg per day and augentropfen stulln mono three drops per day are adopted for 
concomitant therapy starting from the end of the primary efficacy endpoint. 
 
6.5.1 RESCUE MEDICINE 
The study site will supply sacubitril valsartan sodium for rescue medication. 
   
7 
STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
 
7.1 
DISCONTINUATION OF STUDY INTERVENTION 
Discontinuation from Medicine Induced Hemodialysis does not mean discontinuation from the study, 
and remaining study procedures should be completed as indicated by the study protocol. If a clinically 
significant finding is identified (including, but not limited to changes from baseline) after enrollment, the 
investigator or qualified designee will determine if any change in participant management is needed. 
Any new clinically relevant finding will be reported as an adverse event (AE). 
 
7.2 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants are free to withdraw from participation in the study at any time upon request. 
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
 
• 
Pregnancy 
• 
Significant study intervention non-compliance  

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• 
If any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant 
• 
Disease progression which requires discontinuation of the study intervention 
• 
If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
The reason for participant discontinuation or withdrawal from the study will be recorded on the Case 
Report Form (CRF). Subjects who sign the informed consent form and are randomized but do not receive 
the study intervention may be replaced.  Subjects who sign the informed consent form, and are 
randomized and receive the study intervention, and subsequently withdraw, or are withdrawn or 
discontinued from the study, will not be replaced. 
 
7.3 
LOST TO FOLLOW-UP 
A participant will be considered lost to follow-up if he or she fails to return for 3 scheduled visits and is 
unable to be contacted by the study site staff.  
 
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
• 
The site will attempt to contact the participant and reschedule the missed visit(s) and counsel 
the participant on the importance of maintaining the assigned visit schedule and ascertain if the 
participant wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a certified letter to the participant’s last known mailing address or local equivalent methods). 
These contact attempts should be documented in the participant’s medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFICACY ASSESSMENTS  
Diastolic Blood Pressure (DBP) is measured and monitored along with Systolic Blood Pressure (SBP) and 
heart rate. Efficacy for the primary objective is assessed by the three indicators from monitoring data. 
From participant interview, DBP is considered the etiological symptom for SBP sensitivity in elevation, 
and heart rate is considered both an effect from SBP sensitivity and immune response sensitivity 
indicator. Heart rate frequency shifts, therefore, have dual implication in time series and cardiac 
enzymes, myocardiogram, and Color Doppler Ultrasound are tested for further determinations. 
 
Hematological indicators are reorganized for assessments of secondary and exploratory objectives. From 
the baseline characteristics, platelet distribution width (PDW) and mean platelet volume (MPV) have 
been anchored for the main assessment in pharmacokinetic efficacy, along with eosinophil absolute 
number 16,17. The apoptotic pathway is closely monitored for efficacy assessment with neutrophil and 
monocyte indicators 18-20. The determination on each period’s changes’ indications is assisted by 
lymphocyte and basophil indicators, apart from leukocyte regeneration healthiness and differentiation 
trends. 
 

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8.2 
SAFETY AND OTHER ASSESSMENTS 
COVID-19 specific tests are conducted, in combination with the clinical assessments. The efficacy of 
interventional medicines is retrospectively assessed with efficacy contribution plausibility from 
concomitant therapy. Safety assessments are conducted between each efficacy endpoint with relation to 
adverse events. 
   
8.3 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of either the 
investigator or sponsor, it results in any of the following outcomes: death, a life-threatening adverse 
event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant 
incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital 
anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or 
require hospitalization may be considered serious when, based upon appropriate medical judgment, 
they may jeopardize the participant and may require medical or surgical intervention to prevent one of 
the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm 
requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do 
not result in inpatient hospitalization, or the development of drug dependency or drug abuse. 
 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
8.3.3.1 SEVERITY OF EVENT 
The following guidelines will be used to describe severity.  
 
• 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily 
activities.  
• 
Moderate – Events result in a low level of inconvenience or concern with the therapeutic 
measures. Moderate events may cause some interference with functioning. 
• 
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug 
therapy or other treatment. Severe events are usually potentially life-threatening or 
incapacitating.  Of note, the term “severe” does not necessarily equate to “serious”. 
 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
All AEs must have their relationship to study intervention assessed by the clinician who examines and 
evaluates the participant based on temporal relationship and his/her clinical judgment. The degree of 
certainty about causality will be graded using the categories below. In a clinical trial, the study product 
must always be suspect.  
 
• 
Definitely Related – There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an abnormal laboratory test 
result, occurs in a plausible time relationship to study intervention administration and cannot be 

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explained by concurrent disease or other drugs or chemicals. The response to withdrawal of the 
study intervention (dechallenge) should be clinically plausible. The event must be 
pharmacologically or phenomenologically definitive, with use of a satisfactory rechallenge 
procedure if necessary. 
• 
Probably Related – There is evidence to suggest a causal relationship, and the influence of other 
factors is unlikely. The clinical event, including an abnormal laboratory test result, occurs within 
a reasonable time after administration of the study intervention, is unlikely to be attributed to 
concurrent disease or other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal (dechallenge). Rechallenge information is not required to fulfill this definition. 
• 
Potentially Related – There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of the trial medication). However, other 
factors may have contributed to the event (e.g., the participant’s clinical condition, other 
concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it 
can be flagged as requiring more information and later be upgraded to “probably related” or 
“definitely related”, as appropriate. 
• 
Unlikely to be related – A clinical event, including an abnormal laboratory test result, whose 
temporal relationship to study intervention administration makes a causal relationship 
improbable (e.g., the event did not occur within a reasonable time after administration of the 
study intervention) and in which other drugs or chemicals or underlying disease provides 
plausible explanations (e.g., the participant’s clinical condition, other concomitant treatments). 
• 
Not Related – The AE is completely independent of study intervention administration, and/or 
evidence exists that the event is definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
 
8.3.3.3 EXPECTEDNESS  
PI will be responsible for determining whether an AE is expected or unexpected. An AE will be 
considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk 
information previously described for the study intervention. 
 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant presenting for medical care, or upon review by a study monitor. 
 
All AEs including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate CRF. Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study product (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while 
on study must be documented appropriately regardless of relationship. All AEs will be followed to 
adequate resolution. 
 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any 
time during the study, it will be recorded as an AE.  
 

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Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 
 
The research team will record all reportable events with start dates occurring any time after informed 
consent is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study 
participation. At each study visit, the investigator will inquire about the occurrence of AE/SAEs since the 
last visit.  Events will be followed for outcome information until resolution or stabilization. 
 
8.3.5 ADVERSE EVENT REPORTING  
According to 21 CFR 312.64(b), “…The investigator must record nonserious adverse events and report 
them to the sponsor according to the timetable for reporting specified in the protocol”. In addition, 
conditions such as coughing, bodily sores, tiredness, etc. common and expected in the study will not be 
reported per the standard process for reporting. These events will be notified to medical monitor and 
assigned with concomitant therapy. 
 
8.3.6 SERIOUS ADVERSE EVENT REPORTING  
The study clinician will immediately report to the sponsor any serious adverse event, whether or not 
considered study intervention related, including those listed in the protocol or investigator brochure and 
must include an assessment of whether there is a reasonable possibility that the study intervention 
caused the event. Study endpoints that are serious adverse events (e.g., all-cause mortality) must be 
reported in accordance with the protocol unless there is evidence suggesting a causal relationship 
between the study intervention and the event (e.g., death from anaphylaxis). In that case, the 
investigator must immediately report the event to the sponsor. 
 
All serious adverse events (SAEs) will be followed until satisfactory resolution or until the site 
investigator deems the event to be chronic or the participant is stable. Other supporting documentation 
of the event may be requested by the Data Coordinating Center / study sponsor and should be provided 
as soon as possible. 
 
The study sponsor will be responsible for notifying the Food and Drug Administration (FDA) of any 
unexpected fatal or life-threatening suspected adverse reaction as soon as possible, but in no case later 
than 7 calendar days after the sponsor's initial receipt of the information.  In addition, the sponsor must 
notify FDA and all participating investigators in an Investigational New Drug (IND) safety report of 
potential serious risks, from clinical trials or any other source, as soon as possible, but in no case later 
than 15 calendar days after the sponsor determines that the information qualifies for reporting. 
 
8.3.7 REPORTING EVENTS TO PARTICIPANTS  
Events with long-term implications to the participants’ health will be discussed to the participants by the 
PI. 
 
8.3.8 EVENTS OF SPECIAL INTEREST  
The participant’s neurodiverse condition has been reported to the PI. The event leads to the 
adjustments of the study design and plan, just as the SAE that started the study. 
 
8.3.9 REPORTING OF PREGNANCY  
Not applicable. 

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8.4 
UNANTICIPATED PROBLEMS 
 
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
This definition could include an unanticipated adverse device effect, any serious adverse effect on 
health or safety or any life-threatening problem or death caused by, or associated with, a device, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan or application (including a supplementary plan or application), or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of 
subjects (21 CFR 812.3(s)). 
 
8.4.2  UNANTICIPATED PROBLEM REPORTING  
The investigator will report unanticipated problems (UPs) to the reviewing IRB and to the PI. The UP 
report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB project 
number; 
• 
A detailed description of the event, incident, experience, or outcome;  
• 
An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP;  
• 
A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline:   
 
• 
UPs that are SAEs will be reported to the IRB and to the study sponsor within 6 hours of the 
investigator becoming aware of the event.  
• 
Any other UP will be reported to the IRB and to the study sponsor within 24 hours of the 
investigator becoming aware of the problem.  
 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS  
Ups will be discussed with participants by the PI. 
 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.1 
REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
9.1.1 INFORMED CONSENT PROCESS 
 
9.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study intervention. The consent materials have been aggregated with the 
protocol. 
 

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9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent forms will be Institutional 
Review Board (IRB)-approved and the participant will be asked to read and review the document. The 
investigator will explain the research study to the participant and answer any questions that may arise. 
A verbal explanation will be provided in terms suited to the participant’s comprehension of the 
purposes, procedures, and potential risks of the study and of their rights as research participants.  
Participants will have the opportunity to carefully review the written consent form and ask questions 
prior to signing. The participants should have the opportunity to discuss the study with their family or 
surrogates or think about it prior to agreeing to participate. The participant will sign the informed 
consent document prior to any procedures being done specifically for the study. Participants must be 
informed that participation is voluntary and that they may withdraw from the study at any time, without 
prejudice. A copy of the informed consent document will be given to the participants for their records. 
The informed consent process will be conducted and documented in the source document (including the 
date), and the form signed, before the participant undergoes any study-specific procedures. The rights 
and welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
 
9.1.2 STUDY DISCONTINUATION AND CLOSURE 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause.  Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to study participants, investigator, funding agency, the 
Investigational New Drug (IND) or Investigational Device Exemption (IDE) sponsor and regulatory 
authorities.  If the study is prematurely terminated or suspended, the PI will promptly inform study 
participants, the IRB, and sponsor and will provide the reason(s) for the termination or suspension. Study 
participants will be contacted, as applicable, and be informed of changes to study visit schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to participants 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination that the study purpose has been met 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, and data quality are addressed, and 
satisfy the sponsor, IRB and/or Food and Drug Administration (FDA). 
 
9.1.3 CONFIDENTIALITY AND PRIVACY  
Participant confidentiality and privacy is strictly held in trust by the participating investigators, their 
staff, and the sponsor(s) and their interventions. This confidentiality is extended to cover testing of 
biological samples and genetic tests in addition to the clinical information relating to participants. 
Therefore, 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.  
 
All research activities will be conducted in as private a setting as possible. 

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The study monitor, other authorized representatives of the sponsor, representatives of the IRB, 
regulatory agencies or pharmaceutical company supplying study product may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical records 
(office, clinic, or hospital) and pharmacy records for the participants in this study. The clinical study site 
will permit access to such records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by the reviewing IRB, Institutional policies, or sponsor requirements. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored by the PI’s facilities. This will not include the participant’s contact or 
identifying information. Rather, individual participants and their research data will be identified by a 
unique study identification number. The study data entry and study management systems used by 
clinical sites and by PI’s research staff will be secured and password protected. At the end of the study, 
all study databases will be de-identified and archived by the PI with scientific data repository. 
 
9.1.4 FUTURE USE OF STORED SPECIMENS AND DATA  
Data collected for this study will be analyzed and stored by the PI. After the study is completed, the de-
identified, archived data will be transmitted to and stored on Zenodo, for use by other researchers 
including those outside of the study. Permission to transmit data to Zenodo is included in the informed 
consent.  
 
With the participant’s approval and as approved by local IRBs, de-identified biological samples will be 
processed by the local hospital. The hospital reports will be maintained with the blinding of the identity 
of the participant. 
 
When the study is completed, access to study data and/or samples will be provided through Zenodo. 
 
9.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Medical Monitor 
Rev. Yang I. Cao, Ph.D. 
2-28-4 Dexinyuan, 1001 Biqing N Rd, Chongqing, 402762, PRC 
+86 189 1056 6992 
ypach@yangpachankis.us 
 
9.1.6 SAFETY OVERSIGHT 
Safety oversight will be under the direction of a Data and Safety Monitoring Board (DSMB) composed of 
individuals with the appropriate expertis. Members of the DSMB should be independent from the study 
conduct and free of conflict of interest, or measures should be in place to minimize perceived conflict of 
interest.  The DSMB will meet at least semiannually to assess safety and efficacy data on each arm of the 
study. The DMSB will operate under the rules of an approved charter that will be written and reviewed 
at the organizational meeting of the DSMB. At this time, each data element that the DSMB needs to 
assess will be clearly defined. The DSMB will provide its input to the PI. 
 
9.1.7 CLINICAL MONITORING 

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Clinical site monitoring is conducted to ensure that the rights and well-being of trial participants are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the 
trial is in compliance with the currently approved protocol/amendment(s), with International Conference 
on Harmonisation Good Clinical Practice (ICH GCP), and with applicable regulatory requirement(s).  
 
• 
Daily blood pressure monitoring will be conducted by the research team and according to the 
medical necessities of the participant. The participant can do self-monitoring in the tertiary 
phase if choosing to monitor at home. Baseline and endpoint hematology will be conducted by 
the local hospital. Targeted and random review of certain data at endpoints will be conducted 
by the PI. 
• 
Independent audits will not be conducted. 
 
9.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
Each clinical site will perform internal quality management of study conduct, data and biological 
specimen collection, documentation and completion.  An individualized quality management plan will be 
developed to describe a site’s quality management.] 
 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks that will be run on the database will be generated. Any missing data or data anomalies will be 
communicated to the site(s) for clarification/resolution. 
 
Following written Standard Operating Procedures (SOPs), the monitors will verify that the clinical trial is 
conducted and data are generated and biological specimens are collected, documented (recorded), and 
reported in compliance with the protocol, International Conference on Harmonisation Good Clinical 
Practice (ICH GCP), and applicable regulatory requirements (e.g., Good Laboratory Practices (GLP), 
Good Manufacturing Practices (GMP)).  
 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory 
authorities. 
 
9.1.9 DATA HANDLING AND RECORD KEEPING  
 
9.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site 
investigator. The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation 
of data.   
 
Hardcopies of the study visit worksheets will be provided for use as source document worksheets for 
recording data for each participant enrolled in the study.  Data recorded in the electronic case report 
form (eCRF) derived from source documents should be consistent with the data recorded on the source 
documents.  
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data will be entered into iPhone and MacBook. The data system includes password 

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protection and internal quality checks, such as automatic range checks, to identify data that appear 
inconsistent, incomplete, or inaccurate. Clinical data will be entered directly from the source 
documents. 
 
9.1.9.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 2 years after the last approval of a marketing 
application in an International Conference on Harminosation (ICH) region and until there are no pending 
or contemplated marketing applications in an ICH region or until at least 2 years have elapsed since the 
formal discontinuation of clinical development of the study intervention. 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 applicable. It is the responsibility of the sponsor to inform 
the investigator when these documents no longer need to be retained. 
 
9.1.10 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  
• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation, or within 10 working days of 
the scheduled protocol-required activity.  All deviations must be addressed in study source documents, 
reported to the PI. Protocol deviations must be sent to the IRB per their policies. The site investigator is 
responsible for knowing and adhering to the reviewing IRB requirements. Further details about the 
handling of protocol deviations will be included in the MOP. 
 
9.1.11 PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the publicly available data sharing policies and 
regulations for open science practice. 
 
9.1.12 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore, any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this trial will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the design and conduct of this trial. The study leadership 
has established policies and procedures for all study group members to disclose all conflicts of interest 
and will establish a mechanism for the management of all reported dualities of interest. 
 
9.2 
ADDITIONAL CONSIDERATIONS 
It is not certain if complete cure and excretion of S2 proteins from the human host are possible, even after 
the amount being untestable by HIV chemiluminescence test 21,22. 

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9.3 
ABBREVIATIONS 
 
AE 
Adverse Event 
ASD 
Autism spectrum disorder 
BBB 
Blood-Brain Barrier 
CFR 
Code of Federal Regulations 
COVID-19 
Coronavirus Disease 2019 
CRF 
Case Report Form 
DSMB 
Data Safety Monitoring Board 
EB 
Electroencephalogram Biofeedback 
EBS 
Electrical Brain Stimulation 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
GABA 
γ-aminobutyric acid 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
ICH 
International Conference on Harmonisation  
IDE 
Investigational Device Exemption 
ILF-TMS 
Infralow-frequency transcranial magnetic stimulation 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
LSMEANS Least-squares Means 
MedDRA 
Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
PRC 
People’s Republic of China 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SARS-CoV Severe Acute Respiratory Syndrome associated Coronavirus 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
USA 
United States of America 
 
 

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9.4 
PROTOCOL AMENDMENT HISTORY 
The table below is intended to capture changes of IRB-approved versions of the protocol, including a 
description of the change and rationale. A Summary of Changes table for the current amendment is 
located in the Protocol Title Page.  
 
Version 
Date 
Description of Change  
Brief Rationale 
1.0 
2024-03-07 
Initial draft. 
Interim plans. 
 
 
 
 
 
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