Figure 5.

Mean change from baseline in average weekly number of CSBMs over time (ITT analysis set) during the (a) treatment period and (b) RW period. *P < 0.001, †P = 0.001 vs placebo. P values were based on an analysis of covariance model with treatment and pooled investigator site as factors and baseline value as a covariate. Baseline for the treatment period is defined as the average of the first and second weeks of the screening period. Baseline for the RW period is defined as the last valid week of the treatment period. A valid week required at least 4 days of SBM reporting. b.i.d., twice daily; CSBM, complete spontaneous bowel movement; ITT, intention-to-treat; RW, randomized withdrawal.