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Re: Evaluate post# 234251

Sunday, 06/23/2019 1:03:02 PM

Sunday, June 23, 2019 1:03:02 PM

Post# of 693459
Dr. Bosch stated that before you look at the data ['looking' happens after data lock], you have to have the SAP etched in stone in order to preserve the integrity of the analysis. Do you understand? See his presentation at 38:30. They will not go to data lock until the SAP is finalized.

Linda has said the same:

Answer (LP): "Definitely 'yes' we won't unblind until the Statistical Analysis Plan has been approved by all regulators.


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