FIGURE 1.

Subject disposition for ASPIRE extension study. ^aSubject was on an episodic treatment regimen and discontinued owing to a non‐serious adverse event of chronic renal failure that was considered unrelated to recombinant factor VIII Fc fusion protein. ^bSubjects were withdrawn because of the physician's decision for non‐compliance with the study (n = 3). ^cProtocol violations included non‐compliance with prophylactic dosing (n = 1), use of non‐study factor VIII under circumstances that were not an emergency or an accident (n = 2), non‐compliance with study procedures, including infusion timing and concomitant medications (n = 1), lost to follow‐up and incomplete end of study visit (n = 1). ^dIncludes product becoming commercially available in the subject's country (n = 3), commencing a different clinical trial (n = 2), inability to comply with the demands of the study (n = 1), early termination (n = 1) and incarceration (n = 1)