Statistical analyses
All calculations and statistical analyses were performed using SAS® (version 9.2 or later; SAS Institute, Cary, NC). Numerical efficacy endpoints were tested for significance by analysis of covariance (ANCOVA). The dependent variable was the post-baseline variable; the factor of interest was the UO group, and the value at baseline was the covariate. The baseline value was at visit 2, except for some laboratory tests (e.g. lipid profile, safety parameters) where baseline was at visit 1. The proportion of AE was compared between groups using Fisher’s Exact test or Chi-square test, as appropriate. All statistical tests were performed two-sided, and significance was accepted at the P = 0.05 level.