METHODS
SECONDARY
Data were pooled and analyzed post hoc from 2 identically designed, randomized, double-blind, placebo-controlled phase 3 trials in patients with CIC (Assessments included the protocol-specified primary and secondary endpoints from the 2 trials. A complete spontaneous bowel movement (CSBM) was defined as a spontaneous bowel movement (SBM) occurring in the absence of laxative use within 24 hours of bowel movement, with the patient reporting a sense of complete evacuation. A CSBM weekly responder was defined as a patient who had ≥3 CSBMs in a given week and an increase from baseline of ≥1 CSBM in the same week. The primary efficacy endpoint was the percentage of patients who were durable overall CSBM responders during 12 weeks of treatment, defined as patients who were weekly CSBM responders for ≥9 of the 12 weeks, including during ≥3 of the last 4 weeks of treatment. Efficacy endpoints were analyzed in patients subgrouped by age (younger than 65 years or aged 65 years or older), sex/gender (female or male), race/ethnicity (White or non-White individuals), or BMI (<25, 25 to <30, or ≥30 kg/mEfficacy analyses were conducted in the intention-to-treat population (defined as all nonduplicative patients who were randomly assigned to treatment). The safety analysis population included all patients in the intention-to-treat population who received at least 1 dose of study medication. For the primary efficacy endpoint, patients with missing data were considered nonresponders; plecanatide groups were compared with placebo using the Cochran-Mantel-Haenszel test, stratified by sex/gender; and 95% CIs were calculated using the Clopper-Pearson method. 