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Study 1 The safety, efficacy, and PK of ADYNOVATE were evaluated in a multicenter, open-label, prospective, non-randomized, two-arm clinical trial (Study 261201, NCT01736475) that compared the efficacy of a twice weekly prophylactic treatment regimen to on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes

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the inflation volume (mm, means ⁇ SD) was assessed before and after application of spasmogens (histamine, serotonin, acetylcholine, bradykinine, i.v.) or NaBPC157 (10 minutes before repeated spasmogen application, i.v.)