Safety

Safety was assessed by physical examination, AEs (categorized by the Medical Dictionary for Regulatory Activities code), vital signs, ECG, and laboratory tests. The severity of AEs was classified by the investigator as mild, moderate, or severe. Laboratory tests consisted of hematology tests including platelet count, blood chemistry and coagulation tests, urinalysis, and serum cytokine concentrations (interleukin [IL]-2, interferon-γ, tissue necrosis factor-α, IL-6, IL-8). Blood coagulation tests included d-dimer, thrombin-antithrombin complex (TAT), prothrombin time–international normalized ratio (PT-INR), FVIII:C, FIX activity (FIX:C), and FX activity (FX:C). FVIII:C, FIX:C, and FX:C were measured by one-stage clotting assay methods.