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    What You Need to Know to Participate

    This document provides information to help you decide whether to join this research study. It is important you understand the responsibilities, risks and benefits of participating.

    Study TitleMars Men’s Impact on Energy Levels, Sleep and Fatigue
    Study AuthorPatrick Killen, Benjamin Smith
    SponsorThis study is made possible by your payment to join.
    Cost of Products, Services & Information to Participant$79
    Included Products & ServicesMarsMen Natural Testosterone Support
    Outcome MeasuresRating of Perceived Exertion (RPE) Survey, Fatigue Perception and Impact Survey, PROMIS Item Bank v.1.0 – Sleep-Related Impairment Survey, Brief Resilience Scale (BRS) Survey,
    Contacthelp@efforia.com

    Introduction & Summary

    Welcome to the research study on the "Efforia" platform. This study is made possible by your support through participation and financial contribution. The purpose of this study is to understand the impact of MarsMen Natural Testosterone Support on energy levels, sleep quality, and fatigue. Your participation is voluntary, and you can leave the study at any time without any penalty. Please ensure all your questions are answered before proceeding.

    Efforia is a citizen science platform where studies are effectively sponsored by, you, the participants. Unlike traditional research studies, you pay for all the supplies, services, information, and tools needed for participation in one transaction. This makes studies possible that might not be otherwise.

    Although you could buy these products and services separately for a similar cost, Efforia bundles them into one purchase for convenience. Efforia organizes these items and provides instructions to create a comprehensive, data-driven research experience. This setup allows you to track and understand the impact on your own life via detailed outcome reports, making informed personal health decisions easier. It also advances broader research findings, benefiting others who might not afford such purchases without guaranteed results.

    Efforia is committed to equitable inclusion. If the cost is too high for you, click the large Efforia logo at the top of the screen to explore other protocols. Efforia offers protocols on various topics at different price points, including free options, so you can find one that suits your goals and budget.

    Purpose of the Study

    The purpose of this study is to investigate the impact of MarsMen Natural Testosterone Support on energy levels, sleep quality, and fatigue over a 90-day period. We aim to gather scientific insights into the efficacy of MarsMen through your participation. This study will utilize various surveys including the Rating of Perceived Exertion (RPE) Survey, Fatigue Perception and Impact Survey, PROMIS Item Bank v.1.0 – Sleep-Related Impairment Survey, and Brief Resilience Scale (BRS) Survey to measure the outcomes.

    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.

    Welcome to the MarsMen Impact Trial, exploring the effects of our Testosterone Support on your energy and fatigue levels over 90 days!

    I'm Benjamin Smith, the founder of MarsMen. Together with Matthew Amsden, the founder of Efforia, we've designed a comprehensive protocol to investigate how our supplement influences your daily vigor, sleep quality, fitness breakthroughs, and mental fortitude. We're eager to uncover the tangible benefits of MarsMen through your participation, providing scientific insights into its efficacy.

    Here's the plan:

    After establishing your baseline metrics, we'll dispatch a 90-day supply of MarsMen to you. Throughout this period, you'll take five MarsMen capsules daily, with regular reminders from us. Every fortnight, we'll engage you with a series of questions to monitor your progress. By the trial's conclusion, you'll gain a personalized insight into your improvements, benchmarked against fellow participants.

    One unique aspect of our study involves tracking the supplement's effect on your physical exertion levels. Initially, we ask that you select a regular physical activity, lasting 30-60 minutes, which you can perform consistently throughout the 90-100 days, avoiding competitive scenarios. Following each session, we'll inquire about your exertion levels to gauge MarsMen's impact on your energy and exertion perceptions.

    Before we commence, here are some important considerations:

    Should you experience any adverse effects, halt the protocol immediately and consult a healthcare provider, informing us of any diagnoses. Your safety is paramount. For concerns about data security, privacy, or anything else, reach out to help@efforia.com.

    To optimize your experience, consider linking your Google Calendar, MS Outlook, and ToDoist accounts for seamless management of your participation. Ensure you've set your communication preferences to prioritize Efforia emails.

    We're thrilled to have you on board for this journey and look forward to exploring the benefits of MarsMen together.

    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 during 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 email 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.. At the end of the possible benefits of participation section, let the participant know there is a possibility that there will be no measurable benefit to the participant, other than seeing reports that the intervention or treatment had no measurable impact.

    Possible Serious Adverse Events & Side Effects

    Introduction and Summary of Known Risks

    The MarsMen Natural Testosterone Support supplement is designed to support and enhance testosterone levels, energy, and overall well-being over a period of 90 days. As with any therapeutic intervention, it is essential to consider the potential risks and side effects associated with its use. This document outlines the known and possible adverse outcomes of using MarsMen, derived from academic literature, anecdotal evidence, and theoretical considerations.

    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 adverse effects, it is crucial to seek immediate medical attention by calling 911, especially if symptoms are severe. After addressing any acute medical needs, please inform Efforia at help@efforia.com to report the incident and receive further assistance.

    Serious Adverse Events (SAEs)

    Theoretical side effectsRelative incidenceRecovery
    Incidence of CancerVery low likelihoodPermanent and lasting effects
    Exacerbation of chronic diseaseLow likelihoodMay not subside with use; may require discontinuation
    DeathExtremely low likelihoodPermanent and lasting effects
    Life-threatening experienceVery low likelihoodMay require intervention
    HospitalizationLow likelihoodRecovery possible after intervention
    Disability or permanent damageVery low likelihoodPermanent and lasting effects
    Congenital anomaly/birth defectUnknownPermanent and lasting effects
    Required intervention to prevent damageLow likelihoodMay subside with appropriate intervention
    Frustration and irritationMedium likelihoodSubsides after discontinuation

    Common Risks and Side Effects

    Risks associated with MarsMen may include but are not limited to gastrointestinal symptoms such as nausea and diarrhea, skin reactions like rashes, mood changes including irritability, sleep disturbances, and potential effects on liver health. Most side effects are mild and subside with continued use or stop after the treatment is discontinued.

    Efforia's Limitations in Providing Direct Medical Support

    Efforia does not provide direct medical interventions or emergency medical services. It is crucial for participants to have access to local medical services and inform their healthcare providers about participation in this trial.

    Long-term Dependence

    Long-term use of testosterone support supplements like MarsMen could potentially lead to hormonal imbalances or dependence, though this is considered a low likelihood.

    Legality for Use

    The use of MarsMen Natural Testosterone Support may be restricted in certain organizations such as the World Anti-Doping Association (WADA), the National Collegiate Athletic Association (NCAA), and may be prohibited in some corporate workplaces. It is advisable to verify the legality of its use within these institutions to avoid conflicts, especially for athletes and employees subjected to regular drug testing.

    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 agencies, 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 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 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:

    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

    Participants have a role in reducing conflicts of interest as well. 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 is committed to protecting your data. Here’s how we ensure your data’s safety and security:

    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. 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 email 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. There may also be partners who have access to your data, such as 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

    Participants should be aware of the California Experiential Research Subject Bill of Rights. You can access the Efforia privacy policy here: 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
    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 IntegReview. IntegReview is a group of people that have reviewed this research study. The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies. IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review at a convened IRB meeting to:

    Chairperson
    BRANY
    123 Main Street
    Suite 320
    NY, NY 78704
    email@BRANY.com

    If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact our office at:

    555-326-3001
    toll-free at 1-800-123-4567
    between 8 a.m. and 5 p.m. Eastern Standard Time

    Additional Questions and Closing

    Efforia and BRANY have approved the information in this consent form and have 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. It is also up to you to do additional research and talk to your physician before joining a study.

    Consent from

    "*" indicates required fields

    By signing this document with an electronic signature, I agreee that such signature will be as valid as handwritten signatures to the extent allowed by local law.
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