Interim analyses {21b}
EVENTS
Interim analysis will be conducted by the trial statistician and reported to the DSMC when the milestones of 1/3 target enrollment and 2/3 of target enrollment have been met. Statistical evidence of harm at either interim analysis will result in trial discontinuation. In addition, both interm analysis events will evaluate futility using a cutoff of a conditional power to detect 20% as the threshold for either discontinuation of the trial or protocol changes at the discretion of the DSMC.