Challenge/Study Title	Expiration Tests
Challenge Coach (The Person in Charge of This Research Study)	Matthew Amsden
Sponsor	This study is made possible by your payment to join.
Challenge Cost	$0
Included Products & Services
Outcome Measures
Contact	help@efforia.com

Introduction to the Study

Welcome to the “Expiration Tests” research study hosted on the Efforia platform. Efforia is a citizen science platform where studies like this are made possible by participants like you. By contributing financially, you enable this research to proceed when traditional funding isn’t available. Your payment covers all necessary supplies, services, and tools required for participation.

While these products and services could be purchased separately, Efforia bundles them together for convenience and to facilitate a rigorous, data-driven research experience. This approach not only aids in making informed health decisions but also advances broader research findings that could benefit others. Please ensure all your questions are answered before proceeding in this study.

What’s Involved

As a participant, your adherence to the following schedule is crucial for your safety, the study’s outcomes, and its scientific integrity:

Overall Schedule and Timeline

• Initial Consultation and Baseline Measurements: You will have a health check before starting the treatment.
• Treatment Commencement: After the initial checks, you will start the treatment as instructed.
• Regular Monitoring and Follow-up: Your health will be monitored regularly during the treatment period.
• Final Assessment and Debrief: At the end of the treatment, your results will be assessed and discussed.

Treatment Activities and Frequency

• Daily Treatment: Administer the treatment daily as described in your guide.
• Weekly Check-ins: Participate in weekly health check-ins.
• Monthly Assessments: Undergo thorough health evaluations monthly.

Thank you for your commitment to this study. Your participation is vital for achieving meaningful results.

The Purpose of This Study

The aim of this study is to evaluate the effects of the treatment protocol provided. The results will contribute to scientific knowledge and may offer societal benefits by enhancing understanding of the treatment’s effectiveness and safety.

Your Rights as a Participant

Efforia commits to high ethical standards in research, ensuring your rights are protected:

Privacy and Confidentiality

Your personal information is kept confidential and secure from unauthorized access.

Respect and Personal Choice

We respect your autonomy and decision-making in participating in studies that might not be possible under traditional models.

Maximized Benefit and Minimized Risk

The study is designed to maximize benefits and minimize risks to participants, with continuous monitoring for any adverse effects.

Right to Your Own Results

You have the right to a full explanation of the research findings once your participation ends.

Feedback Mechanism

If you have complaints or feedback, please contact us at help@efforia.com, and we will respond within 2 business days.

The Right to Leave a Study without Penalty

You can withdraw from the study anytime without penalty and receive refunds for unused products as per our return policy.

Risks and Benefits

Introduction and Summary of Known Risks

The treatment involves Testosterone Replacement Therapy (TRT), aimed at supplementing low testosterone levels. This section outlines the known risks associated with TRT, which is critical for making an informed decision about participation.

Common Known Risks and Side Effects

• Gastrointestinal Symptoms: Nausea and increased liver enzyme levels can occur.
• Skin & Hair Reactions: Acne, oily skin, and hair loss are common.
• Headaches and Dizziness: These are usually temporary.
• Mood Changes: Increased aggression and irritability have been reported.
• Sleep Disturbances: Includes sleep apnea.
• Weight & Body Composition Changes: Weight gain and changes in body composition are expected.
• Muscle or Joint Pain: Typically transient and related to physical changes.
• Mental Health Discomfort: Changes in libido and possible exacerbation of mental health conditions.
• Sexual Side Effects: Variations in sexual performance or desire.
• Cognitive Impairment: Memory lapses or fogginess.

Serious Adverse Events (SAEs)

• Incidence of Cancer: Particularly prostate cancer, though data is inconclusive.
• Exacerbation of Acute or Chronic Disease: Conditions like heart disease may worsen.
• Life-threatening Experiences and Hospitalization: Severe cardiac issues could occur.
• Disability or Permanent Damage: Long-term misuse could lead to irreversible effects.
• Congenital Anomaly/Birth Defects: Risks to the fetus if used during pregnancy.

Long-term Dependence Issues

Long-term use of TRT may suppress natural testosterone production, requiring ongoing therapy.

Legality and Institutional Acceptance

• World Anti-Doping Association (WADA): TRT is considered doping unless an exemption is granted.
• National Collegiate Athletic Association (NCAA): Requires documentation for therapeutic use.
• Corporate Workplace: Acceptance varies by company policy.

In the Case of an Adverse Event

Seek immediate medical care if severe side effects or unusual symptoms occur. Efforia can assist in contacting healthcare professionals but does not provide direct medical support.

Conclusion

While TRT can improve quality of life for those with low testosterone, it carries potential risks and requires medical supervision.

No Benefit: You may not receive any benefit from the treatment, despite financial contributions.

Acknowledgment of Risk and Responsibility

As participants in a citizen science trial, there are unique responsibilities and risks:

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.”

Responsible for any Additional Costs & Medical Care

“In the case of an adverse event, it is the participant’s sole responsibility to seek and finance their medical treatment. Efforia, as a non-sponsor, is absolved from any claims and cannot reimburse any expenses incurred.”

Reporting Adverse Events

It is crucial to report any adverse events to Efforia to promote safety and awareness within the community.

The Limits of Efforia Medical Oversight

If the study involves lab tests or prescription items, Efforia will provide asynchronous medical oversight. However, this does not replace the need for personal responsibility or local medical care.

Legal Acknowledgment

“This document serves as a legally binding acknowledgment of the risks associated with participating in a study and explicitly limits Efforia’s liability. Efforia will not be held liable for any claims except in cases of gross negligence or willful misconduct. This acknowledgment underscores the importance of personal diligence and responsibility throughout the study participation.”

Conflict of Interest Statement

Efforia operates as a platform provider and does not sponsor or influence the study outcomes. Efforia earns a transaction fee on all products and services included in this protocol, ensuring no financial conflicts of interest.

How we Reduce Conflicts of Interest

It is crucial that participants have no financial relationship with the intervention methods or measurement providers, nor should they be employees, investors, stakeholders, or protocol authors associated with these entities.

Consequences of Conflict of Interest Non-Compliance

Should a conflict of interest or breach of this policy be discovered, the participant will be subject to immediate suspension from the platform and additional legal proceedings may be initiated.

“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 in compliance with data protection laws, ensuring the confidentiality and integrity of participant information.

California Experiential Research Subject’s Bill of Rights

Participants in California can refer to the California Experiential Research Subject’s Bill of Rights for additional protections.

Additional questions and closing

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

1. Authorization and Consent for Diagnostic Testing
2. I voluntarily consent and authorize CWI Physician Partners P.C., a California professional corporation; CWI Physician Partners P.C., a Hawaii professional corporation; CWI Physician Partners P.C., a Georgia professional corporation; CWI Physician Partners P.C., a Kansas professional corporation; CWI Physician Partners P.C., an Oregon professional corporation; CWI Physician Partners P.C., a Nevada professional corporation, CWI Physician Partners P.C., a Rhode Island professional corporation; CWI Physician Partners P.C., an Oklahoma professional corporation, as applicable (“CWI”) to review the collection, testing, and analysis for the purposes of a diagnostic screening test. I understand that there are risks and benefits associated with undergoing a diagnostic screening testing and there may be a potential for false positive or false negative test results. I assume complete and full responsibility to take appropriate action with regards to my test results. Should I have questions or concerns regarding my results, or a worsening of my condition, I shall promptly seek advice and treatment from an appropriate medical provider. I further acknowledge the following:
   1. I am the individual who will provide the sample for the Test(s) that I am requesting or I am the parent or legal guardian of a minor who is providing the sample for testing.
   2. I am at least eighteen (18) years of age or I am the parent or legal guardian of a minor who is providing the sample for testing.
   3. I have read and understand the information provided about the Test(s) that I have been provided on the website where I requested the Test.
   4. The information I have provided in connection with my request to CWI is correct to the best of my knowledge. I will not hold CWI or its employees or agents responsible for any errors or omissions that I may have made in providing such information.
   5. My health information and results may be shared with CWI employees and agents for the purpose of ordering, processing, and reporting my results.
   6. Medical Services provided by CWI are purely for diagnostic assistance purposes and do not create a physician-patient relationship, and do not constitute medical care or diagnosis or treatment of any condition, disease, or illness.
   7. I authorize CWI to contact me via text message to communicate with me regarding my test.
3. Patient Rights and Privacy Practices
   1. Notice of Privacy Practices and Patient Rights: CWI Notice of Privacy Practices describes how it may use and disclose your protected health information for other purposes that are permitted or required by law. To review a copy of CWI Notice of Privacy Practices, go to http://www.CynergyWellness.com.
   2. Disclosure to Government Authorities: I acknowledge and agree that my test results and associated information may be disclosed to appropriate county, state, federal, or other governmental and regulatory entities as may be permitted by law.
4. Release
   1. To the fullest extent permitted by law, I hereby release, discharge and hold harmless, CWI, including, without limitation, any its respective officers, directors, employees, representatives and agents from any and all claims, liability, and damages, of whatever kind or nature, arising out of or in connection with any act or omission relating to my diagnostic test or the disclosure of my test results.
   2. By selecting the ACKNOWLEDGEMENT during the registration process for diagnostic testing, I acknowledge and agree that I have read, understand, and agreed to the statements contained within this form. I have read the contents of this form in its entirety and voluntarily consent to proceed with these procedures.