Thereafter, they received on-demand TACE but not systemic chemotherapy.
Of these, 49 patients received on-demand treatment in period 1, 47 patients were randomized to the two prophylactic treatment sequences, and 39 patients received on-demand treatment during period 3. Patient demographics are summarized in Table 1.
Data were obtained from study periods 1 and 3 when patients received on-demand treatment with nonacog alfa.
This was followed by an 8-week period during which patients received on-demand treatment only, with a dose and treatment plan similar to that of Period 1 (Period 3).
In brief, patients received on-demand treatment with nonacog alfa for 16 weeks, with dosing adjusted based on the investigator's judgment, according to body weight and bleeding severity (Period 1).
All 13 subjects enrolled in Israel received weekly prophylaxis treatment with rIX-FP for the duration of the study (range = 37 48 weeks), and all four subjects enrolled in Bulgaria received on-demand treatment (ODT) for bleeding episodes with rIX-FP for the duration of the study (range = 15 22 weeks).
44, 47, 52 The long-term use of on-demand dapoxetine has been addressed in just one study (see Table 3), ie, a 9-month extension study of the two 12-week trials described by Pryor et al. 47 All of the 1774 men enrolled in the extension study received on-demand dapoxetine 60 mg, regardless of prior treatment group in the original studies (dapoxetine 30 mg, 60 mg, or placebo).
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