Monday, June 20, 2022 1:09:21 PM
Laugh riot.
Ex, protocol changes are rarely made public.
They clearly went to blinded analysis which included unblinded safety analysis by the DMB which is allowable.
You are just trying to push them for more information, when they’ve told you and everyone they decided to conduct blinded yearly analysis starting in Spring 2015.
This obviously took the place of interim efficacy analysis. Efficacy analysis would have had stopping guidelines for certain thresholds.
They had an information arm and expanded use arm outside the trial to tell them psPD was confounding the trial.
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