Interim analyses
ADVERSE EVENT
Interim analyses will be conducted solely for the DSMB reports and annual reports to the funder. The analyses include subject accrual, adverse event (AE), and serious adverse event (SAE) rates by arm, overall retention and retention by arm, adherence by study arm, and stopping rules regarding statistical power implications of drop-outs and missing data. All of these analyses with the exception of adherence by study arm will be available to all investigators and DSMB members. The investigative team, except for the statistician compiling the report, will not have access to adherence by arm since it is a primary outcome.