Efficacy in Control of Bleeding A total of 757 new bleeding events were observed during the study. Assessment of response to each injection was recorded by subjects at 8 to 12 hours post-treatment. A rating scale of excellent, good, moderate, and no response was used to assess response. Bleeding episodes are summarised in Table 6. Table 6: Summary of Efficacy in Control of Bleeding New bleeding episodes (n= 757) # of Injections to bleeding episodes 1 injection 661 (87.3%) 2 injections 79 (10.4%) 3 injections 13 (1.7%) injections 4 (0.5%) ≥4 (n=755) Median dose per injection 27.35 (IU/kg) to treat a bleeding (22.73, episode (IQR) 32.71) Median total dose (IU/kg) 28.23 to treat a bleeding episode (23.26, (IQR) 46.88) Response to first injection (n= 745) Excellent or 78.1% good Moderate 21.2% No response 0.7% Efficacy in Perioperative Management (Surgical Prophylaxis) Nine (9) surgical procedures were performed in nine subjects. Haemostasis was assessed post-operatively by the investigator using a 4-point scale of excellent, good, fair,
Efficacy in Control of Bleeding A total of 757 new bleeding events were observed during the study. Assessment of response to each injection was recorded by subjects at 8 to 12 hours post-treatment. A rating scale of excellent, good, moderate, and no response was used to assess response. Bleeding episodes are summarised in Table 6. Table 6: Summary of Efficacy in Control of Bleeding New bleeding episodes (n= 757) # of Injections to bleeding episodes 1 injection 661 (87.3%) 2 injections 79 (10.4%) 3 injections 13 (1.7%) ≥4 injections 4 (0.5%) (n=755) Median dose per injection (IU/kg) to treat a bleeding episode (IQR) 27.35 (22.73, 32.71) Median total dose (IU/kg) to treat a bleeding episode (IQR) 28.23 (23.26, 46.88) Response to first injection (n= 745) Excellent or good 78.1% Moderate 21.2% No response 0.7% Efficacy in Perioperative Management (Surgical Prophylaxis) Nine (9) surgical procedures were performed in nine subjects. Haemostasis was assessed post-operatively by the investigator using a 4-point scale of excellent, good, fair,
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