Summary Information to Help you Decide Whether to Join this Study

Study Title	Cardiovascular and Sexual Health Enhancement Protocol
Study Author	Matthew Demo Amsden Test
Sponsor	This study is made possible by your payment to join.
Cost of Products, Services & Information to Participant	$0
Included Products & Services	Adam Health Erection/Nitric Oxide Support Supplement, Adam Sensor – Nocturnal Erection Tracker
Outcome Measures	International Index of Erectile Function Survey, PROMIS® Scale v2.0 – Satisfaction With Sex Life Survey, Adam Sensor: Nocturnal Penile Tumescence,
Contact	help@efforia.com

Introduction & Summary

Welcome to the Cardiovascular and Sexual Health Enhancement Protocol research study hosted on the "Efforia" platform. Your participation is invaluable in driving forward scientific discovery and understanding, and we appreciate your support.

This document provides key information to help you decide if you want to take part in this study. The purpose of this study is to explore the potential benefits of specific interventions on cardiovascular and sexual health. Participation is entirely voluntary, and you can choose to leave the study at any time without any consequences. If you have any questions or concerns, please reach out to us before deciding to participate.

Purpose of the Study

This study aims to investigate the effects of the Adam Health Erection/Nitric Oxide Support Supplement and the Adam Sensor in enhancing cardiovascular and sexual health. The study will use the International Index of Erectile Function Survey and PROMIS® Scale v2.0 – Satisfaction With Sex Life Survey to measure outcomes. The Adam Sensor will track nocturnal penile tumescence to provide additional insights.

The Adam Health Erection/Nitric Oxide Support Supplement is designed to support circulatory health and improve erectile function by enhancing nitric oxide levels. The Adam Sensor is a wearable device that monitors nocturnal erections, providing data on erectile function during sleep. By participating, you contribute to a better understanding of these interventions which could lead to improved health outcomes for many.

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

"It is possible that not all risks and benefits are currently known. Participants have the responsibility to consult with their healthcare providers and conduct further research before enrolling in the study."

Personal and Overall Findings

Efforia will provide you with both personal outcomes as well as 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: Adam Health Erection/Nitric Oxide Support Supplement and Adam Sensor – Nocturnal Erection Tracker

Introduction and Summary of Risks

The Adam Health Erection/Nitric Oxide Support Supplement and Adam Sensor – Nocturnal Erection Tracker are designed to enhance cardiovascular and sexual health. While these products aim to improve erection quality and overall sexual satisfaction, it is crucial to consider potential risks associated with their 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.

In the Case of an Adverse Event

If you experience any severe or alarming symptoms after using the Adam Health products, seek immediate medical attention by calling 911. Once the acute situation has been addressed, please contact Efforia to report the incident. This will help us monitor the product's safety and improve future user guidance.

Serious Adverse Events (SAEs)

Theoretical side effects	Relative incidence	Recovery
Exacerbation of pre-existing cardiovascular conditions	Low to moderate likelihood	May require medical intervention but usually subsides after discontinuation
Allergic reactions (e.g., hives, swelling, anaphylaxis)	Very low likelihood	Immediate medical treatment required; typically reversible upon treatment
Severe psychological distress	Low likelihood	May persist without psychological intervention
Frustration and irritation	Moderate likelihood	Subsides with adaptation or discontinuation of use

Risks Overview

• Gastrointestinal Symptoms: Some users may experience mild stomach discomfort. These symptoms are generally transient and subside with continued use.
• Skin & Hair Reactions: Rare instances of rashes or hair loss have been reported, potentially linked to allergic reactions to supplement ingredients.
• Mood Changes: Mood swings and irritability may occur, particularly in the initial phases of treatment.
• Cognitive impairment: Temporary cognitive fog or distraction may be noted, usually resolving after the body acclimates to the supplement.
• Breathing or respiratory issues: Although extremely rare, some individuals might experience respiratory distress related to allergic reactions.

Efforia’s limitations in providing direct medical support

Efforia does not provide direct medical interventions. Users are advised to consult healthcare professionals for any medical concerns.

Long-term Dependence

No long-term dependence has been noted with the use of Adam Health Erection/Nitric Oxide Support Supplement or Adam Sensor. However, continuous monitoring is recommended.

Legality and Compliance

The Adam Health products are compliant with general health supplement regulations but have not been specifically reviewed by the World Anti-Doping Association, National Collegiate Athletic Association, or Corporate Workplaces for use in regulated environments. Users should consult their respective regulatory bodies before beginning treatment.

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: https://efforia.com/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.

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 any study-related injury after you've received any necessary treatment. We want to make sure 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 cace 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 is 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:

Ethical Considerations: 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.

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:

Should a participant fail to disclose such a conflict of interest or if a breach of this policy is discovered, the participant 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:

Efforia collects, uses, and protects data in accordance with data protection laws.

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: https://efforia.com/privacy-policy.

Who will have access to your data?

Efforia will have access to your data. And 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.

California Experiential Research Subject’s Bill of Rights:

For more information, please visit the Efforia privacy policy at https://efforia.com/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
(646) 679-2479
OR CLICK THE CHAT BUTTON ON YOUR SCREEN
If you are unable to reach anyone at the number(s) listed above and you require immediate (life-threatening) medical attention, please 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 at (919) 910-7743 or via email at info@univo-group.com.
Univo IRB
4509 Creedmoor Road
Suite 403
Raleigh, NC 27612
info@univo-group.com
(919) 910-7743

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 Univo 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.