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Re: DewDiligence post# 217944

Thursday, 03/15/2018 8:21:39 PM

Thursday, March 15, 2018 8:21:39 PM

Post# of 252311

Are they using each patient's historical-record baseline to compute the on-treatment delta for the (secondary) delta-bleed endpoint calculation?
That strikes me as unreliable.


Yes, from clinicaltrials.gov
Must have been on prophylactic FVIII replacement therapy for at least 12 months prior to study entry. High-quality, well-documented historical data concerning bleeding episodes and FVIII usage over the previous 12 months must be available.

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