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The randomized withdrawal period enrolled 48 patients (BOS-BOS, n= 25; BOS-PBO, n= 23); 106 induction partial responders and nonresponders, and 65 induction placebo patients received BOS. More BOS-PBO than BOS-BOS patients relapsed over 36 weeks (43.5% vs 24.0%; P= .131) and had histologic responses at week 12 of therapy (P .001). Overall, 13.2% of induction partial responders and nonresponders fully responded at week 36. BOS was well tolerated; therapy duration was not associated with new safety concerns. For induction full responders