2. Established severe hemophilia A (factor VIII procoagulant activity (FVIII:C) <1%, measured following ≥5 days without factor VIII (FVIII) treatment), and/or documented intron 1 inversion or intron 22 inversion mutation in the F8 gene, consistent with severe hemophilia A, AND documented evidence of ≥3 hemorrhages over the previous 12 months requiring treatment with exogenous FVIII or use of FVIII prophylaxis because of history of frequent bleeding episodes.