Document Classification

Section Type: RESULTS

Text: The primary efficacy endpoint occurred in 162/217 3. 0 g OD patients (75 %), 129/212 1. 5 g OD patients (61 %) and 150/218 0. 5 g t. d. s. patients (69 %) in the intention-to-treat population, and in 152/177 (86 %), 121/182 (67 %) and 144/185 (78 %) in the per protocol population respectively ; 3. 0 g OD was superior to both low-dose regimens for the primary endpoint (i. e. P < 0. 001, 3. 0 g OD vs. 1. 5 g OD ; P = 0. 024, 3. 0 g OD vs. 0. 5 g t. d. s.; superiority test, per protocol population).