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12/02/22 1:01 AM

#387448 RE: Anshu2 #387436

The difference in slides is too large a difference to be due to just the ITT vs mITT (n=170 vs 168 placebo and n=338 vs 335 treated). It should have been explained. The 5 patients probably represent those who passed the screen but withdrew before the 1st pill of either placebo or drug. Thise 5 could have dropped out for any reason, usually because patientor family changes their mind. mITT is a valid population for analysis and 1% loss from screening to dosing (ITT to mITT) is not concerning to me. I've seen other studies where mITT is just referred to as the ITT.