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11/26/21 11:44 AM

#421795 RE: exwannabe #421789

exwannabe,

And you describe perfectly the rational behind the exceptions rule to adequately and well controlled trials guidances that led to the change in the SAP at the end of the trial which is exactly as guidance suggests for trials that have already started when an inadequate form of treatment benefit measurement is discovered and then being replaced. Thank you for reminding me to once again point this out to you and any others that are still “unaware” after all these years ; ). Best wishes.