Eligible patients were males (any age) with severe or moderately severe hemophilia A with FVIII ≤2% receiving on-demand FVIII at the time of study enrolment and who had >50 previous exposure days (EDs) to any recombinant or plasma-derived FVIII, a negative inhibitor result at screening (defined as <0.6 Bethesda units/mL [BU/mL]), and no history of inhibitor development. Patients were discontinued from the study if they required a surgical or dental procedure.

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