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Re: hoffmann6383 post# 560488

Friday, 01/20/2023 3:09:42 AM

Friday, January 20, 2023 3:09:42 AM

Post# of 822388
It is post hoc when the protocol, endpoints, comparators and SAP are completely changed AFTER the trial is virtually complete. Only two weeks between new protocol and data lock.

FDA knows what post hoc is and certainly will treat the trial that way. Too bad.
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