Summary Information to Help You Decide Whether to Join this Study

Study Title	Repeating Test Protocol
Study Author	Reviewer User
Principal Investigator	Matthew Amsden, CEO Efforia. Dr. Viral Patel Sub-Investigator for Adverse Events
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services
Outcome Measures
Contact	help@efforia.com

Introduction & Summary

Welcome to our research study hosted on the "Efforia" platform. We invite you to join us in this exciting exploration made possible by your support. Efforia is a registered Delaware B Corporation, a new kind of corporation that may consider the public good in business decision-making in addition to traditional monetary and financial considerations.

This document provides key information to help you decide whether to participate in the study. The study aims to explore new scientific knowledge and societal benefits. Your participation is voluntary, and you may leave the study at any time without penalty. You can continue using the products and services you've purchased, or you may be eligible for a partial or full refund by reaching out to Efforia.

If you have any questions, we encourage you to reach out to Efforia, conduct your own research, and consult with healthcare professionals familiar with your circumstances.

Purpose of the Study

The purpose of this study is to conduct a thorough investigation into the effects and outcomes of specific daily treatment activities. By participating, you contribute to scientific knowledge and help advance societal benefits. The study aims to provide insights that may influence future health-related decisions and practices.

What You Will Do as Part of this Study

While participating in this research study, you will need to:

• Be willing and able to follow the study directions and procedures
• Tell Efforia about any side effects or problems by communicating with help@efforia.com or online chat.
• Ask questions as you think of them, via help@efforia.com or online chat.
• Inform Efforia if you change your mind about staying in the study. You may leave the study at any time by communicating with help@efforia.com or chat.

The Risks, Discomforts & Benefits of Being in this Study

There are some unique risks, discomforts, and potential benefits of being in this study that you should understand.

Consider your Own Risk-Benefit Comfort Level

We encourage you to thoroughly weigh the risks and benefits of participation. We are placing more responsibility on you to make the right choice than in a traditionally sponsored trial. Since this is an experimental exercise, there may be possible unknown side effects that the authors are unaware of. Participants have the responsibility to consult with their healthcare providers and conduct further research at sources they find reputable before enrolling in the study.

Personal and Overall Findings

Efforia will provide you with both personal outcomes and overall findings. These findings will be made available at various data collection points in your experience in the study or as they are discovered by Efforia. The results and findings may impact your interest and willingness to be involved in the study. Remember, participation is voluntary, and you may exit at any time with an e-mail to help@efforia.com.

Possible Benefits of Participation

No Benefit: A key risk to all studies is that there is no benefit, and that participants receive no benefit from the proposed intervention or treatment, despite the financial payment the participant has made.

There is a possibility that there will be no measurable benefit to you, other than seeing reports that the intervention or treatment had no measurable impact.

Possible Serious Adverse Events & Side Effects

Interventional New Drug Application: Safety and Risk Assessment

Introduction

The following is a summary of known risks. However, research is limited, and there may be risks not covered by this document, risks that are currently unknown or unforeseen. Please consider these risks carefully, do your own research, and talk to a professional who knows you well and has expertise in this area, like your personal physician.

In the Case of an Adverse Event

If you experience a serious adverse event, seek immediate medical care by calling 911 or visiting the nearest emergency room. Once the acute situation has been addressed, please contact Efforia to report the incident. This helps us monitor the safety profile of our treatments and improve future care.

Known Risks and Side Effects

The most common risks associated with the product include gastrointestinal symptoms, skin and hair reactions, headaches, fatigue, and mood changes. These side effects have been identified through a combination of academic research, anecdotal evidence, and reports on online forums. The maximum dosages tested in animal studies or human trials are currently not available, which limits the scope of safety data.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Incidence of Cancer	Very low likelihood	Permanent effects
Exacerbation of chronic disease	Low likelihood	May subside with discontinuation
Death	Extremely low likelihood	Permanent
Life-threatening experience	Very low likelihood	May subside with discontinuation
Hospitalization (initial or prolonged)	Low likelihood	Depends on the severity
Disability or permanent damage	Low likelihood	Permanent
Congenital anomaly/birth defect	Very low likelihood	Permanent
Required intervention to prevent permanent impairment or damage	Low likelihood	Depends on the intervention
Frustration and irritation	Medium likelihood	Subsides with use

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical support. Users should maintain contact with their healthcare providers for ongoing medical care and advice.

Long-Term Dependence

No known long-term dependence issues have been identified with the use of this treatment based on the available data.

Legality for Use

The use of this product in relation to sports and employment is not specifically restricted by the World Anti-Doping Association, National Collegiate Athletic Association, or corporate workplace policies. However, participants should verify the acceptability of this treatment within their specific organizations or governing bodies.

This document aims to provide an overview of what is currently known about the risks associated with this treatment. It is essential for users to remain informed and consult healthcare professionals for personalized advice.

Inappropriate Participants Inclusion/Exclusion

Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.

Based on the information provided (risks informed consent and intervention), I am unable to create the specific table you requested. Please provide additional details about the risks associated with the study, the nature of the intervention, and the outcome measures to identify the categories of individuals who should avoid participating.

Privacy & Security Risks

We are doing everything we can think of to keep your data private and confidential. However, there is no such thing as no risk. Potential participants should review the Efforia general privacy policy, which is available here: Efforia Privacy Policy.

There may be very certain limits to the rights of your privacy:

• We may reach out to local help if we have reason to believe you may be a harm to yourself and/or others.
• Regulators, like the FDA or similar agency, or Institutional Review boards may review records that have your identifying information.

What to do if you have a study related injury

If you experience any problems, side effects, or study-related injuries, it's important to seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. After receiving any necessary treatment, please contact Efforia to report the issue. We want to ensure that others are aware of potential risks.

Study related injury care and compensation

Efforia is not able to offer financial compensation nor to absorb the costs of medical treatment should you be injured as a result of participating in this research. Efforia makes no commitment to provide free medical care or payment for any unfavorable outcomes resulting from participation in this research.

In the case of medical emergency

In the case of medical emergency please dial 911 immediately. Do not attempt to contact Efforia until after the emergency has passed. Access local in person medical assistance immediately. If at any time you feel like you may be a danger to yourself or others, please dial 988 for the National Suicide Prevention hotline. Help is available.

Alternatives to Participating in the Study

Since this study is for research only, the only other choice would be not to be in the study. If this study does not seem quite right or too expensive for your specific purposes, Efforia is dedicated to making other studies available. You may click on the Efforia logo in the upper portion of the page and find a different study that may be more appropriate.

Your Rights as a Participant

Efforia upholds the same high ethical standards in research as seen in pharmaceutical and academic studies, despite only hosting and not sponsoring or conducting these studies. Your participation in this study is completely voluntary, and you are free to withdraw at any time without any adverse consequences. You are not giving up any rights by signing this document.

Efforia may remove you from the study if you have violated Efforia's overall terms and conditions, privacy policy, or have a conflict of interest. Efforia may also remove you from the study in the interest of safety based on individual or community findings.

Privacy and Confidentiality

You have a right to privacy and confidentiality in this research effort. Your personal information is protected through robust measures ensuring anonymity or confidentiality. All data processing is designed to safeguard personal data against unauthorized access and misuse.

Right to Your Own Results

Participants have the right to a complete explanation of the research once their involvement concludes, particularly if the study involves any form of deception like placebos or controls.

The Right to Leave a Study without Penalty at Any time

If you decide to withdraw from the study, you can do so at any time by visiting your Profile page, selecting "Your Protocols," and clicking "Leave." Upon leaving, you will be refunded for any consumable products that have not yet been shipped. For non-consumable products, a full refund will be issued upon their return in accordance with our return policy. This ensures that you can participate in the study with the assurance that your financial contributions are handled fairly and with respect for your consumer rights.

Conflict of Interest Statement

As part of our commitment to ethical conduct and transparency in our citizen science clinical trial, it is essential to disclose the unique structure of our study. This clinical trial is hosted by Efforia, but it is uniquely sponsored by you, the participants. Efforia serves solely as the platform provider and does not sponsor or influence the study outcomes.

Efforia takes a transaction fee on all the products and services included in this protocol. Otherwise, we have no financial interest or conflicts of interest. To further reduce conflicts of interest, we will remind you once if you do not complete enrollment in this study. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest

It is crucial that participants do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities. Participation under such conflicts of interest could significantly compromise the study's integrity and the validity of its results.

Consequences of Conflict of Interest Non-Compliance

If you fail to disclose such a conflict of interest or if a breach of this policy is discovered, you will be subject to immediate suspension from this platform and payments may not be refunded.

By joining this trial, you affirm that you understand the above conflict of interest restrictions and agree to comply fully with them. Your participation is valued, and your adherence to these guidelines ensures the validity and reliability of our collective scientific efforts.

Data Protections

Data will be collected, used, and protected, ensuring compliance with data protection laws. You own your own data, and it will be housed on Efforia indefinitely until you tell us to delete it by e-mailing help@efforia.com.

What you can do to improve your privacy and security

As part of participating in this study, you will receive notifications via e-mail, SMS, or push notification when new study tasks like questionnaires and reminders are ready for you. You can adjust your communication preferences in the Efforia application at any time. If you do not want to receive notifications from this study, do not press the Accept button. You can decide not to join this study, and will not receive notifications. To ensure others don’t see these alerts, you should make sure your phone or desktop computer and your e-mail accounts are protected by a password, pin, or other form of “access control.” You should also avoid sharing your accounts with others or sharing your account passwords. As this study is hosted in Efforia, it is governed by a set of privacy and confidentiality standards that put you, as a participant, in control. You can learn more about Your Privacy and Security rights on Efforia here.

Who will have access to your data?

Efforia will have access to your data. There may be partners who also have access to your data (like labs and connected health devices).

What will we do with your data?

We will use the data to show you your own personal results, and pool your results with other participants to provide general outcomes. We will not use your information connected with your name or anything that connects the data with you without your permission.

Authorization to Use and Disclose Protected Health Information

If you decide to take part in this study, the study doctor and study staff may use and share protected health information (PHI) about you to conduct the study. Protected health information may come from your medical or research records. Protected health information may include the following:

• Name
• Location
• Dates
• Phone Numbers
• Email Addresses
• Internet protocol (IP) address numbers

The study staff may share protected health information about you with the following authorized users to ensure the quality of the study conduct and study data:

• Efforia
• The Office of Human Research Protections (OHRP);
• Univo Institutional Review Board; and
• University of Portsmouth Ethics Review Board
• Other regulatory agencies

Once your protected health information has been shared with authorized users, it may no longer be protected by federal privacy laws and could possibly be used or disclosed in ways other than what is listed in this section.

Your permission to use and share protected health information about you will end after you have completed the study and any after study related activities unless you revoke your permission sooner.

You can revoke your permission to use and share protected health information about you at any time by contacting the study doctor listed on the first page of this document. If you revoke your permission, you will not be able to stay in this study. No new protected health information will be collected after your request has been received. The protected health information about you that has already been collected may still be used and given to others as described in this section.

If you decide not to sign and date this document, you will not be able to take part in the study. However, you may continue to use and consume anything you've purchased to be part of the study outside the study.

California Experiential Research Subject’s Bill of Rights

For participants in California, please refer to the California Experiential Research Subject Bill of Rights for additional information on your rights. You can also review the Efforia privacy policy here.

Who to Contact for Questions or Concerns

If you have questions, concerns, or complaints about this study or to report a study related injury, contact:

HELP@EFFORIA.COM
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
We will immediately respond with an automated message giving you a sense of how long a more meaningful response will take based on the volume of other requests.

(646) 679-2479. If no one is available, please leave a message. We will typically respond to telephone messages in three to five business days.

If you are unable to reach anyone at the number(s) listed above and you require immediate (life threatening) medical attention, please dial 911 in the US/Canada or 999 in the UK and/or go to the nearest emergency room.

If you do not want to talk to the investigator or study staff, if you have concerns or complaints about the research, or to ask questions about your rights as a study subject you may contact Univo IRB. Univo IRB is an independent committee that helps to protect the rights and welfare of research participants. If you have any questions about your rights and welfare as a research participant, or have concerns or complaints regarding this research study, please contact:

Univo IRB
(919) 910-7743 or via email at info@univo-group.com.
Univo IRB
4509 Creedmoor Road Suite 403
Raleigh, NC 27612

Additional questions and closing

Efforia and Univo have approved the information in this consent form and has given approval to public this study. This does not mean Efforia or BRANY have approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.

If you have questions please contact help@efforia.com. Also, it is up to you to do additional research and talk to your physician before joining a study.