D+A / BPO was noninferior to ISO in the intent-to-treat population -LSB- @ % confidence interval ( CI ) -@ to @ ( P = @ ) ; @ % vs. @ % of subjects , respectively -RSB- and per-protocol population -LSB- @ % CI @-@ ( P = @ ) ; @ % vs. @ % of subjects , respectively ) , based on the composite efficacy/safety end point .