Summary Information to Help you Decide Whether to Join this Study

Study Title	New Prefill Task Testing
Study Author	Reviewer User, Zeeshan Web
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	Cream Sofa, Gift Card – Test, Withings Sleep Mat
Outcome Measures	General Anxiety Disorder (GAD-7), Sense of Agency Scale
Contact	help@efforia.com

Introduction & Summary

Welcome to our research study on the Efforia platform. Your participation is crucial, and by joining, you help support this research initiative. Efforia is a registered Delaware B Corporation, meaning we consider the public good as part of our business decisions.

This study aims to help you decide whether to join by offering a detailed outline. 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 even if you decide to leave. If you prefer not to continue using them, partial or full refunds may be available depending on the study timeline. Please reach out to Efforia at help@efforia.com for any refund inquiries.

If you have questions, we encourage you to contact Efforia, conduct your own research, and discuss with a health professional familiar with your circumstances.

Purpose of the Study

The study is designed to evaluate the transition to a gluten-free lifestyle, aiming to enhance scientific understanding and societal benefits. Participants will use products like the Cream Sofa and Withings Sleep Mat, while outcome measures include the General Anxiety Disorder (GAD-7) and the Sense of Agency Scale. These tools will help assess participants' progress and experiences throughout the study.

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."

Once you complete enrollment and enter your personal and shipping details, you will participate in tasks designed to facilitate your transition to a gluten-free lifestyle. The schedule is structured to ensure a comprehensive understanding and implementation of gluten-free practices over a designated timeline.

The study begins with an Introduction Task, where you will complete an "Email Test" to familiarize yourself with the communication tools and protocols. Following this, you will engage in tasks such as:

• Gluten-Free Shopping: Learn to identify and purchase gluten-free products in various shopping environments.
• Cooking Gluten-Free Meals: Prepare meals using gluten-free ingredients, focusing on nutritional balance and variety.
• Understanding Food Labels: Read and interpret food labels to ensure compliance with gluten-free dietary requirements.
• Adjusting to Gluten-Free Choices: Adapt daily habits and preferences to include gluten-free options seamlessly.

The treatment activities will be conducted weekly, with each task building on the previous one to ensure a gradual and comprehensive adaptation to a gluten-free lifestyle. You will also undergo periodic assessments to measure progress and adherence to the study's requirements.

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

Thoroughly weigh the risks and benefits of participation. We place 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 available at various data collection points during your study experience. They may impact your interest and willingness to continue. Remember, participation is voluntary, and you may exit at any time by emailing 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

In the Case of an Adverse Event

If you experience any severe or unexpected side effects or reactions while using the Withings Sleep Mat, seek immediate medical attention by calling 911. After addressing any acute situations, please contact Efforia to report the incident. This will help us monitor the safety and effectiveness of our products and support you appropriately.

Introduction and Summary of Risks

The Withings Sleep Mat is designed to monitor sleep patterns and provide insights into sleep quality. While it is generally considered safe for use, there are potential risks and side effects associated with its use. These include minor skin irritations from prolonged contact with the device, as well as potential interference with other medical devices. Maximum dosages in terms of exposure duration have not been explicitly defined, but it is advised to follow the manufacturer's guidelines for use.

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.

Serious Adverse Events (SAEs)

The Withings Sleep Mat is unlikely to directly cause serious adverse events (SAEs) as defined, such as life-threatening experiences, hospitalizations, or permanent damage. However, it is essential to consider its compatibility with other medical devices and conditions. The following table lists potential risks associated with its use:

Theoretical side effects	Relative incidence	Recovery
Skin irritation	Low	Symptoms subside with discontinued use
Interference with medical devices	Very low	Corrects after discontinuation
Frustration and irritation	Medium	Symptoms subside with continued use

Efforia's Limitations in Providing Direct Medical Support

Efforia does not provide direct medical support or interventions. Users are advised to consult with healthcare professionals for any medical concerns or severe reactions related to the use of the Withings Sleep Mat.

Long-Term Dependence Issues

There are no known long-term dependence issues associated with the use of the Withings Sleep Mat. It is designed for monitoring purposes and does not involve any pharmacological treatments.

Legality for Use by Various Institutions

The Withings Sleep Mat is a non-invasive monitoring device and is generally permissible under regulations by the World Anti-Doping Association, National Collegiate Athletic Association, and in general corporate workplaces. However, individuals should verify with their specific institutions or employers to ensure compliance with any specific policies or restrictions.

This document aims to provide a comprehensive overview of the potential risks and legal considerations associated with the Withings Sleep Mat. Users are encouraged to remain informed and consult with appropriate medical professionals to ensure safe usage.

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.

Category of Individual	Contraindications	Reason
Individuals with celiac disease	Participation may not be suitable without guidance	Gluten-free diet is necessary, but incorrect implementation may lead to nutrient deficiencies without professional advice.
Individuals with non-celiac gluten sensitivity	Participation may not be suitable without guidance	Similar to celiac disease in requiring a gluten-free diet, professional guidance is needed to avoid nutritional imbalances.
Individuals using medical devices	Potential interference with device functionality	The Withings Sleep Mat may interfere with some medical devices, requiring careful consideration and consultation with a healthcare provider.
Individuals with sensitive skin	May experience skin irritation	Prolonged contact with the Withings Sleep Mat could cause skin irritation, necessitating a trial period or alternative placement strategy.
Individuals prone to frustration	May experience increased irritation	The Sleep Mat may cause frustration or irritation, which could affect mental well-being, requiring consideration of stress management strategies.

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. Please review the Efforia general privacy policy: Privacy Policy.

There may be 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 Institutional Review Boards, may review records that have your identifying information.

What to do if you have a study related injury

If you have a study-related injury, seek local medical care first, if necessary. Efforia cannot provide emergency medical care or diagnosis. However, it is important to contact Efforia if you experience any problems, have any side effects, or have a study-related injury after receiving any necessary treatment. This helps us make others 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 high ethical standards in research, similar to pharmaceutical and academic studies. Your participation is completely voluntary, and you can 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 violate Efforia's overall terms and conditions, privacy policy, or have a conflict of interest. We may also remove you for safety reasons 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, 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. We will not remarket to you, nor otherwise push you to join the study.

How we Reduce Conflicts of Interest

You have a role in reducing conflicts of interest as well. It is crucial that you do not have any financial relationship with the intervention methods or measurement providers used in the trial, nor should you be an employee, investor, stakeholder, or protocol author 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

Should 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

Your data will be collected, used, and protected in 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 emailing 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 email, 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. To ensure others don’t see these alerts, make sure your phone or desktop computer and your email accounts are protected by a password, pin, or other form of access control. Avoid sharing your accounts or passwords. You can learn more about Your Privacy and Security rights on Efforia here: Privacy Policy.

Who will have access to your data?

Efforia will have access to your data. There may be partners, such as labs and connected health devices, who also have access to your data.

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 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

Learn about the California Experiential Research Subject Bill of Rights. You can find more information in the Efforia privacy policy: Privacy Policy.

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 have given approval to publish 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. It is up to you to do additional research and talk to your physician before joining a study.