*Decreased CD4 lymphocyte count in a patient with a history of HIV infection and combined tibia–fibula fracture in a patient who received treatment with another FVIII product, which was prohibited during the study; †Hematochezia, alanine aminotransferase increase, asparate aminotransferase increase, FVIII level increase, VWF antigen increase.2 AE, adverse event; CD4, cluster of differentiation4; FVIII, factor VIII; SAE, serious adverse event; TESAE, treatment-emergent serious adverse event; VWF, von Willebrand factor.