D+A / BPO was noninferior to ISO in the intent-to-treat population [ 95 % confidence interval ( CI ) -27 to 208 ( P = 013 ) ; 639 % vs. 549 % of subjects , respectively ] and per-protocol population [ 95 % CI 39-286 ( P = 001 ) ; 743 % vs. 58 % of subjects , respectively ) , based on the composite efficacy/safety end point .