Adverse events
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, ADVERSE EVENT
Adverse events were collected via a standardized adverse events questionnaire at each study and clinical visit, and participants were encouraged to contact study staff between study visits if adverse events occurred. These were tracked in an Adverse Events Log, and any unanticipated and/or severe adverse events were reported to the Institutional Review Board (IRB) at the time of the adverse event. All adverse events were reported to the IRB annually as part of the continuing review process.