Primary Efficacy End Point

Modified intention-to-treat population: all randomized patients who received study drug had ≥ 1 postdose primary efficacy assessment completed.

LS, least squares; SBM, spontaneous bowel movement.

*P = .0014 vs placebo; **P = .0003 vs placebo and P = .6657 vs 0.2 mg (analysis of covariance with treatment group as a term and baseline value as a covariate).

Reproduced with permission from L Webster, MD.