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13th Nov 2015, 07:33 PM
#1
I don't see a problem. 5.1 of E9 requires The statistical analysis plan ... to be completed after finalising the protocol.... and should be finalised before breaking the blind. So between those two dates. I'm sure that inspectors would like to see the drafts created and would look for sound rationales for any dramatic changes in the SAP. The SAP will always be reviewed to see if it is; fit-for-purpose , unbiased, fair, scientifically appropriate and statistically sound.
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