A Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.
Phase: NA
Conditions: Height, Cognitive Function, Weight Gain
Sponsor: NuBest

 
 
A Randomized, Double-blind, Placebo-controlled 
Study to Evaluate the Effects of a Dietary 
Supplement on Children’s Health and 
Development Outcomes 
 
Protocol Number: 20424 
NCT Number: NCT06704178 
Principal Investigator: Swathi Varanasi, PharmD. 
Sponsor: NuBest 
Clinical Research Organization: Citruslabs 
Funded by: NuBest 
Version Number:  v.3.0 
14 March 2024 
 
 
 
 
 
 
Summary of Changes from Previous Version: 
 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
 
 
 
 
 
 
 
 
 
 
 
 
 

2 
 
 
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)  
 
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.  The protocol and 
consent form must be approved before enrolling any participant.  Any amendment to the protocol 
will require review and approval by the IRB before the changes are implemented in 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. 
 
 
 

3 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
Title: 
A Randomized, Double-blind, Placebo-controlled Study to Evaluate 
the Effects of a Dietary Supplement on Children’s Health Outcomes 
 
Study Description: 
This is a virtual, two-armed, randomized, double-blinded, placebo-
controlled clinical trial that will last 6 months. Participants will take the 
NuBest Tall Growth Protein Powder or a placebo product daily.  
 
The children's parents will complete questionnaires at baseline and 
regularly during the study period (Month 1, Month 2, Month 3, Month 
4, Month 5, and Month 6).  
 
The children will complete cognitive assessments at home at Baseline 
and Month 6 (Endline).  
 
Parents will also provide height and weight measurements of the 
children at Baseline, Month 2, Month 4, and Month 6.  
 
Objectives: 
Primary Objective:  
To examine the effect of the NuBest Tall Growth Protein Powder on 
cognitive function.  
 
Secondary Objective:  
To investigate the impact of the NuBest Tall Growth Protein Powder on 
a range of health parameters, including height, weight, energy levels, 
immune function, and digestion.  
 
Endpoints: 
Primary Endpoint:  
The primary endpoint of this study is an improvement in cognitive 
function. Cognitive battery testing scores will be compared across the 
trial measurement points.  
 
Secondary Endpoints:  
The secondary endpoint is an increase in a range of parameters 
associated with health, including height, weight, energy levels, immune 
function, and digestion. Parents will provide height and weight 
measurements for the children and will complete questionnaires 
evaluating other health outcomes.  
 
Study Population: 
This study will recruit 60 participants (60 pairs of parents + child). The 
parents may be of any age group, the children must be aged as follows:  
● Boys: 12 to 16 years 
● Girls: 10 to 14 years 
 
Arm 1: Intervention - 30 participants 

4 
Arm 2: Placebo - 30 participants 
Description 
of 
Sites/Facilities 
Enrolling 
Participants: 
Virtual 
Description 
of 
Study Intervention: 
● After eligibility is established, participants will complete a 
Baseline questionnaire, the Baseline cognitive assessment, 
and provide the Baseline height and weight measurements.  
● Participants will be randomly allocated to either the intervention 
or placebo group. The participants and Citruslabs will not be 
informed who is in the test or the placebo group. 
● Participants will begin taking their respective product for 6 
months. The children will drink one scoop of the powder mixed 
with 6-8 oz of water, milk, or smoothies. 
● Parents will complete questionnaires at the end of Month 1, 
Month 2, Month 3, Month 4, Month 5, and Month 6, and will 
provide further height and weight measurements at Month 2, 
Month 4, and Month 6. 
● The children will repeat the cognitive assessments at Month 6 
(endline). 
Study Duration: 
6 months  
Participant 
Duration: 
6 months 
Product 
Instructions: 
● The test products must be consumed in the morning.  
● Combine one scoop of the powder with 6-8 oz of water, milk, or 
smoothies. 
● Do not use NuBest Protein Powder for baking or cooking 
recipes. 
 
Stadiometer 
Instructions:  
● Step 1: Upon powering on the device, securely affix it to the 
wall, ensure that the height measuring instrument remains 
perpendicular to the ground and parallel to the wall at a 90-
degree angle. 
● Step 2: Once you've adjusted the height accordingly, press the 
measurement key only in the absence of any obstacles. 
● Choose a flat ground without steps, and try to avoid testing on 
carpets or uneven areas with plush carpets or rugs.  
● Ensure the device is perpendicular to the ground. 
 
Compensation 
● $150 Visa gift card  
● FitBit Smart Scale 

5 
● Ultrasonic Height Measuring Stadiometer 
 
 
1.2 
SCHEMA 
 
Prior to  
Enrollment 
 
 
 
 
 
 
Intervention 
 
 
 
 
 
Total N=60  Obtain informed consent. Screen potential participants by inclusion and 
exclusion criteria. Parents complete baseline questionnaire and provide height and weight 
measurements of the chidlren. Children complete the cognitive assessments. Participants 
allocated into intervention (arm 1, N=30) or placebo (arm 2), N=30). 
Intervention Information 
Study Period  (6  months). Participants will take 1 scoop of the powder every morning, 
mixed with water, milk, or a smoothie.  
Participants will complete questionnaires at Months 1, 2, 3, 4, 5, 6 and provide height and 
weight measurements  of the children at Month 2, Month 4, and Month 6. 
Children will repeat cognitive assessments at Month 6 (endline).  
 
Final Assessments 
Statistical analysis performed on all 
data collected. 

6 
 
1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
 
Procedures 
Screening 
Intervention 
Conclusion 
Informed Consent 
x 
 
 
Demographics 
x 
 
 
Inclusion/ Exclusion 
x 
 
 
Administer 
Study 
Intervention 
 
x 
 
Questionnaires 
x 
x 
x 
Height 
& 
Weight 
Measurements 
x 
x 
x 
Cognitive 
Battery 
Testing  
x 
 
x 
Adverse event Review 
and Evaluation 
x 
x 
x 
 
 
2 
 
INTRODUCTION 
 
2.1 
STUDY RATIONALE  
 
Protein is fundamental to growth and the repair of body tissues; hence, its adequacy in children's 
diets is critical for optimal physical development. Studies have highlighted the role of dietary 
protein in increasing height and weight in children, suggesting a direct correlation between protein 
intake and growth metrics1-3. Similarly, essential vitamins such as Vitamin A, C, D, E, and B-
complex and minerals like Calcium, Iron, and Zinc have well-documented contributions to other 
aspects of physical development, bone health, immune function, and cognitive development4,5. 
For instance, Vitamin D’s role in bone mineralization is well-documented6, while Iron and Zinc 
have been associated with cognitive function and immune defense7 Furthermore, emerging 
research on the gut-brain axis underscores the significance of digestive health in cognitive and 
immune system functions, advocating for the inclusion of probiotics and prebiotic fibers in dietary 
regimens for children8.  
In the USA, many people are at risk of vitamin, mineral, and/or other micronutrient deficiencies9-
11. Children and adults are consuming more low-nutrient foods with added sugar and excess fats 
as compared to healthy, high-quality calories and micronutrients. The risk of this is further 
exacerbated by socioeconomic and family income to poverty ratio10. However, research has 
suggested that dietary supplements can be helpful in meeting nutrient requirements for some 
micronutrients. 

7 
With this in mind, the test product has been developed and contains a proprietary blend of 
vitamins, minerals, and probiotics designed to enhance children's and teenager’s health 
outcomes through the aforementioned mechanisms. This study will assess the effects of the test 
product on a range of health outcomes in children over the course of 6 months.  
 
 
2.2 
RISK/BENEFIT ASSESSMENT   
 
 
Immediate risks:  
There are no predicted risks associated with this product. However, some people may experience 
adverse reactions when trying a new product. NuBest Tall Protein contains milk-based 
ingredients, so it is not suggested for those with a dairy allergy. It does not contain soy, grain, 
wheat, GMO, or gluten. 
As dairy can interact with a number of medications, all medications should be separated by a 
minimum of 4 hours from taking the test product. 
 
Long-term risks:  
There are no predicted long-term risks related to using this product. Any short-term risk should 
dissipate after discontinuing the test product. 
 
Immediate benefits:  
Participants may experience positive changes in overall health. Also, participants might 
experience increased energy levels, immune function, and overall well-being. 
 
Long-term benefits:  
Participants may experience an increase in height, maintenance of a healthy weight, and 
enhanced quality of life due to an increase in overall health.  
 
3 
OBJECTIVES AND ENDPOINTS 
 
 
OBJECTIVES 
ENDPOINTS 
TIMEPOINTS 
ASSESSED BY 
JUSTIFICATION 
FOR ENDPOINTS 
Primary 
To 
examine 
the 
effect of the NuBest 
Tall Growth Protein 
Powder 
cognitive 
function.  
Improvement 
in 
score 
on 
assessments: 
● 
Double 
Trouble 
● 
Feature 
Match  
● 
Grammatical 
Reasoning 
● 
Digit Span 
● 
Token 
Search 
 
Baseline 
and 
Month 6 
Cognitive Battery 
Testing  
The combination of 
these 
cognitive 
assessments 
will 
provide 
objective 
data on the efficacy 
of the product in 
improving 
specific 
domains of cognitive 
function.   
Secondary 
Increase in height  
 

8 
To investigate the 
impact 
of 
the 
NuBest Tall Growth 
Protein Powder on a 
range 
of 
health 
parameters, 
including 
height, 
weight, 
energy 
levels, 
immune 
function, 
and 
digestion.  
 
Baseline, Month 2, 
Month 4, Month 6 
(height & weight 
measurements) 
Height measured 
using 
an 
Ultrasonic Height 
Measuring 
Stadiometer 
The combination of 
objective 
measurements and 
questionnaires 
will 
provide 
both 
independent 
and 
participant 
perception data on 
secondary 
health 
parameters. 
Maintenance 
of 
a 
healthy weight 
Increase 
energy 
levels  
Improved signs of 
digestive health  
Weight measured 
using 
a 
FitBit 
Smart Scale.  
Baseline, Month 1, 
Month 2, Month 3, 
Month 4, Month 5, 
Month 6.  
Increased 
immune 
function 
(assessed 
via the number of 
times the child has 
been ill in the past 6 
months) 
Study-specific 
questionnaires  
 
 
 

9 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
This study is a randomized, double-blinded, placebo-controlled trial of 60 parent and child 
combinations i.e. 60 parents and 60 children. 
 
Participants will be randomized into one of two arms. This study will be double-blinded; the study 
participants and study coordinators will be blinded to the intervention or product allocation. Arm 1 
will take NuBest Tall Growth Protein Powder throughout the trial. Arm 2 will take a placebo product 
for the duration of the trial. Only the children will take the test product.  
 
The parents will answer questionnaires at Baseline and on Month 1, Month 2, Month 3, Month 4, 
Month 5, and Month 6. Parents will provide height and weight measurements of the child at 
Baseline, Month 2, Month 4, and Month 6. The children will complete cognitive assessments at 
Baseline and Month 6. The trial will be a virtual study consisting of only virtual assessments, and 
the participants will follow the use instructions provided by the research team.  
 
4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
To best understand the actual benefits of the test product without the influence of a potential 
placebo effect, a randomized, placebo-controlled, double-blinded study design is the gold-
standard method. A 6-month study duration provides sufficient time for the test product to provide 
metabolic effects that may lead to enhanced health outcomes.  
 
The data collection intervals for this trial were chosen to minimize the participant burden while still 
collecting valuable data about the efficacy of the test product. In addition to subjective data 
collected from questionnaires, height and weight measurements using a standardized tool will 
provide a non-biased, independent assessment of changes in height and weight across both 
groups. In addition, the cognitive assessments will provide an objective measurement of changes 
in cognitive function.  
 
4.3 
JUSTIFICATION FOR DOSE 
 
The test product examined in this study will be taken in the exact dosage of the commercially 
available product. This will be done to help establish marketing claims that can be used with the 
test product and to understand the current formulation of the test product. 
 
4.4 
END OF STUDY DEFINITION 
 
A participant is considered to have completed the trial if they have completed all study phases, 
including the last scheduled assessments: Month 6 questionnaire, weight measurements, height 
measurement, and cognitive assessment. 
 
 
 
 

10 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
To be eligible to participate in this study, an individual must meet all of the following criteria: 
 
1. A parent of a child within the following age ranges:  
● Boy: 12 to 16 years 
● Girl: 10 to 14 years 
2. Interested in their child trialing a dietary supplement designed to improve overall health 
outcomes in children, including height, maintenance of a healthy weight, cognitive 
function, immune function, and energy levels.  
3. Willing to refrain from giving their child any vitamins, minerals, or herbal supplements of 
any kind for the duration of the study 
4. Parents willing to weigh and measure the height of their child throughout the study 
5. Generally healthy - do not have any uncontrolled chronic disease 
 
 
5.2 
EXCLUSION CRITERIA 
An individual who meets the following criteria will be excluded from participation in this study: 
 
1. Any child with a history of endocrine disorder, heart disease, lung disease, kidney disease, 
digestive disease or skeletal dysplasia.  
2. Any pre-existing chronic conditions that would prevent participants from adhering to the 
protocol, including oncological and psychiatric disorders. 
3. Is undergoing or planning to undergo significant medical procedures in the next six 
months. 
4. A history of severe allergic reactions, including but not limited to any of the product's 
ingredients. 
5. Any child with a dairy allergy or lactose intolerance. 
6. Has undergone any surgeries or invasive treatments in the last six months. 
7. Has had any major illness in the last three months. 
8. Having any planned invasive medical procedures during the study period  
9. Currently participating in any other clinical study.  
10. Unwilling to follow the study protocol. 
11. Any child diagnosed with attention-deficit disorder (ADD) or attention-deficit hyperactivity 
disorder (ADHD).  
12. Any child currently taking, or have they taken in the last 3 months, any prescription 
medication targeting ADD or ADHD (such as Adderall, Concerta, Focalin, Evekeo, or 
Ritalin).  
13. Any child that is a ‘fussy’ eater or who the parent suspects may not tolerate consuming 
the test product daily for six months. 
5.3 
PARTICIPANT COMPENSATION 
 
All participants will be compensated $150 for their time and effort in the form of a Visa gift card. 
Participants will also be permitted to keep the FitBit Smart Scale and the Ultrasonic Height 
Measuring Stadiometer.  
 
 

11 
5.4 
JUSTIFICATION OF SAMPLE SIZE 
 
60 participants, 30 each in the intervention and placebo arms, is sufficient to establish differences 
between the two study conditions. This will allow for meaningful between-group comparisons to 
adequately assess the efficacy of the test product versus placebo control.  
 
 
6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION  
 
● Potential participants (parents + child) who meet the initial inclusion and exclusion criteria 
can participate in this trial 
● If participants meet the inclusion and exclusion criteria after the parents have signed the 
informed consent, participants will begin the trial.  
● The parents will complete the Baseline questionnaire and provide the Baseline height and 
weight measurements of the children. The children will complete the Baseline cognitive 
assessments.  
● After the baseline data collection, participants will be randomly allocated into the 
intervention or placebo study group. The participants and Citruslabs will not be informed 
who is in the intervention or the placebo group. 
● The children will take 1 one scoop of the powder mixed with 6-8 oz of water, milk, or 
smoothies every morning.  
● Parents will complete questionnaires at the end of Month 1, Month 2, Month 3, Month 4, 
Month 5, and Month 6.  
● Parents will provide height and weight measurements of the children at Month 2, Month 4 
and Month 6.  
● The children will repeat the cognitive assessments at the end of Month 6.  
● Completion of the Month 6 measurements marks the end of the study. 
  
6.2 
INTERVENTION FORMULATION 
 
Intervention Product: Protein, Vitamin A, Vitamin C, Vitamin D, Vitamin E, Thiamine, Riboflavin, 
Niacin, Vitamin B6, Folate, Vitamin B12, Biotin, Pantothenic Acid, Choline, Calcium, Iron, 
Phosphorus, Iodine, Magnesium, Zinc, Selenium, Copper, Chloride, Sodium, Potassium, Organic 
Flax Seed Powder, L-Taurine, Inositol Hexanicotinate, L-Arginine, Bacillus subtilis DE111® 
Complex (1 Billion CFU) (Probiotic), Eucommia Bark Extract, Vitamin K, Whey Protein 
Concentrate, Chocolate Bean Powder Processed with Alkali, Organic Evaporated Cane Sugar, 
Milk Protein Concentrate, Guar Gum Powder, Natural Flavor, Potassium Chloride, Silicon Dioxide, 
Rebaudioside A (from Stevia Leaf Extract), Sucralose. 
 

12 
 
 
Placebo Product Ingredients: Maltodextrin, Guar gum powder, Silicon dioxide, Cocoa powder, 
Natural creamy vanilla flavor, Organic evaporated cane sugar, Stevia leaf extract, and Sucralose.  
 
 
 
 
 
6.3 
RANDOMIZATION AND BLINDING 
 
Participants will be randomized into the intervention group (NuBest Tall Growth Protein Powder) 
or into a placebo product control group. Randomization occurs via a randomization tool that will 
equally place participants into a group that will use product A or B. The research coordinator who 
will conduct the randomization will not know which product is the test product and which is the 
control.  
 

13 
This study will be double-blinded; the study participants and study coordinators will be blinded to 
the intervention or product allocation. Only the sponsor will know which product, A or B, contains 
the active ingredients. After the study is complete, the allocation will be unblinded prior to the 
analysis. Both groups will receive products that look identical.  
 
6.4 
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  
● 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 
● Participant should be withdrawn from the study if they start on a new drug or receive 
antibiotics 
 
The reason for participant discontinuation or withdrawal from the study will be recorded on a Case 
Report Form (CRF). Participants who sign the informed consent form but do not receive the study 
intervention may be replaced.  Participants who sign the informed consent form, receive the study 
intervention, and subsequently withdraw, or are withdrawn or discontinued from the study, will not 
be replaced. 
6.5 
IN-PERSON DIAGNOSTIC TESTING 
 
N/A 
 
 

14 
 
6.6 
COGNITIVE BATTERY TESTING   
 
All children will complete cognitive assessments at the following time points:  
● Baseline  
● Month 6 
 
The tests included are as follows:  
 
Double Trouble - 1:30 timed test 
● Based off of a classic Stroop test, Double Trouble measures selective attention, 
processing speed, and the brain's ability to focus on specific information when 
presented with conflicting and layered stimuli 
Feature Match - 1:30 timed test 
● Feature Match is a focus and processing task that requires surveying an increasingly 
difficult array of information and rapidly assessing the correct response while holding 
previously processed and detailed information in attention 
Grammatical Reasoning - 1:30 timed test 
● Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting 
phrases and making logical conclusions from understanding. Variation between text and 
shapes on screen require holding key information in short-term memory in order to 
properly complete the task, leveraging the same parts of the brain that enable an 
individual to remain focused between varied stimuli. 
Digit Span - performance-based test (3-4 min) 
● Increasing in length after each successful attempt, Digit Span requires users to focus 
on displayed numbers, hold them in short-term memory, and repeat them back correctly, 
thereby showing cognitive flexibility and the brain's ability to perform memory and 
attention related tasks without error 
Token Search - performance-based test (3-4 min) 
● Leveraging the brain's executive functioning skills, Token Search requires participants 
to hold information in working memory and remain focused on completing sequential 
steps without making mistakes. The tasks become increasingly difficult, requiring more 
active utilization of brain regions associated with processing, attention, and memory as 
the task continues. 
 
6.7 
REQUIRED DEVICES 
 
Participants require access to a computer, laptop, or tablet to complete the cognitive 
assessments.  
 

15 
All participants will be provided with the FitBit Smart Scale and the Ultrasonic Height Measuring 
Stadiometer required for the height and weight measurements.  
 
7 
STATISTICAL CONSIDERATIONS  
 
Following data collection and the completion of the trial, the data will be analyzed by Citruslabs 
to determine the effect of the intervention versus the placebo. Between-arm and participant 
repeated measures between time point statistical tests will be used to examine differences in 
health outcomes during the study and compared to the placebo. Percentages of people who 
experienced improvements will also be examined. The analysis will adopt an intent-to-treat (ITT) 
approach, reflecting the primary objective of assessing the effectiveness of the test product as it 
would be used in the general population, inclusive of all randomized participants, irrespective of 
adherence or protocol deviations. 
 
 
8 
CONSENT, PRIVACY AND OTHER POLICIES 
 
8.1 
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 following consent materials are submitted with 
this protocol: an informed consent form and a patient bill of rights. 
 
8.2 
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. These documents will explain the research study to the participant and answer any 
questions that may arise. A verbal or written 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 will 
be 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. 
 
8.3 
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 
(not applicable to this study). Therefore, the study protocol, documentation, data, and all other 

16 
information generated will be held in strict confidence. No information concerning the study or the 
data will be released to any third party without prior written approval of the sponsor.  
 
The study participant’s contact information and records will be securely stored on an AWS server. 
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. 
 
8.4 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of Citruslabs, which is responsible for ensuring the accuracy, 
completeness, legibility, and timeliness of the data reported. 
 
Trial data will be entered into a 21 CFR Part 11-compliant data capture system provided by 
Citruslabs. The data system includes password 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. 
 
8.5 
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 CRO staff. As a result of deviations, corrective actions are to be developed by the trial 
administrator (Citruslabs) and implemented promptly.  
 
It is the responsibility of Citruslabs to use continuous vigilance to identify and report deviations 
within 7 working days of identification of the protocol deviation or within 7 working days of the 
scheduled protocol-required activity. Protocol deviations must be sent to the reviewing 
Institutional Review Board (IRB) per their policies. Citruslabs is responsible for knowing and 
adhering to the reviewing IRB requirements. 
 
8.6 
PUBLICATION AND DATA SHARING POLICY 
This study will be conducted in accordance with the following publication and data sharing 
policies: the study may be published in an open-access preprint server. The study administrators 
(Citruslabs) will be acknowledged in any publications relating to this study. This trial may be 
registered with clinicaltrials.gov, and results may be submitted to clinicaltrials.gov following 
publication. No part of this study, including protocol and results, may be published in any form 
without explicit prior approval in writing by the study sponsor. 
 
8.7 
CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence 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. Any employees of, or 
people with any connection to, the sponsor or Citruslabs will not be eligible for participation in this 
study. 
 
The sponsor has a conflict of interest in that they may benefit financially from the success of the 
study. To manage the conflict of interest, an independent third party (Citrusabs) will be handling 

17 
all design and administration of participant-focused materials, all participant recruitment and data 
gathering, and data analysis. 
 
 
9 
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