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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