Impact of Medically Supervised Performance-Enhancing Substances (PES) on Elite Athletes

Exclusion Criteria

• •Participants are excluded from the study if any of the following criteria apply:
• •1. A self-reported history of any significant psychological or psychiatric challenges that may affect their ability to safely engage in the study or comply with study procedures. This includes, but is not limited to:
• •1. Ongoing or recently unstable conditions such as severe depression or other psychiatric disorders that have not been effectively managed, in the judgement of the clinical research team.
• •2. A history of severe mental health conditions (e.g., schizophrenia, bipolar disorder) that have required intensive intervention or hospitalization within the past 5 years.
• •2. Prior history of malignancy (including breast cancer, lymphoma, leukemia) within the past 5 years except for cervical or prostate carcinoma in situ that has been completely resected or cured basal or squamous cell skin carcinoma.
• •3. Has a history of CV disease that includes any of the following:
• •1. Unstable CV disease, myocardial infarction, unstable angina, cardiac bypass or coronary arteries stenting, cerebrovascular accident (stroke), or transient ischemic attack.
• •2. Clinically significant cardiac arrhythmias, including congenital arrhythmia syndromes (e.g. Long QT syndrome, Brugada Syndrome) or acquired arrhythmias, including pacemaker or ICD.
• •Note. Cases will be considered on a case-by-case basis following an expert sports cardiology review using the newest internationally published recommendations.
• •3. Congestive heart failure (New York Heart Association class II to IV symptoms) or inherited or acquired cardiomyopathies Note. Cases will be considered on a case-by-case basis following an expert sports cardiology review using the newest internationally published recommendations.
• •4. Current or history of clinically significant (per Investigator's judgment) liver or biliary disease.
• •5. Current acute or chronic self-reported HCV and/or HBV infection.
• •6. Current or history of clinically significant renal disease (per Investigator's judgment) or GFR \<60mL/min/1.73m2
• •7. Has history or presence of any results from Screening Visit laboratory tests, ECG, physical examination, or vital signs that, in the opinion of the Investigator, Medical Monitor, or Sponsor, should be exclusionary for such a candidate.
• •8. The use of other investigational drugs at the time of screening or within 30 days or 5 half- lives prior to signing of the ICF, whichever is longer, or longer if required by local regulations.
• •Note. Upon entry into the long-term follow-up phase of the study, participation in another clinical trial may be permitted only if it does not interfere with the objectives of this study. This is at the discretion of the study Investigator.
• •9. Pregnant or breastfeeding.
• •10. Has a mental or legal incapacity.
• •11. Is unwilling to provide written informed consent or is unable to follow the procedures outlined in the Protocol.
• •Prospective approval of protocol deviations to recruitment and eligibility criteria, also known as protocol waivers or exemptions, is not permitted.