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Re: Astavakra post# 195679

Tuesday, 09/05/2017 7:36:45 PM

Tuesday, September 05, 2017 7:36:45 PM

Post# of 403134
Adding 10 patients meant a change in protocol and should require IRB approval (see K Phase 1), so I don't think safety was a concern in the two P arms. IPIX probably requested this change several weeks in advance since IRB usually meets once every two weeks. So the adaptive design of adding more patients to the 400 mg arm could be a reason.



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