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The proportion of patients showing minimal and moderate clinical improvement based on the PAC-SYM total score was calculated. The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and was consistent with the guidelines for Good Clinical Practice. The institutional review boards or independent ethics committees of the participating medical centers approved the study protocol and informed consent document. All patients gave written informed consent before any study-related tests were performed. Patients: A total of 469 patients with chronic nonmalignant pain and OIC were randomized, of which 460 received at least one dose of study treatment. The modified intent-to-treat (mITT) population VX 809 of 460 patients was analyzed for constipation symptoms. There Cefaloridine were 388 subjects (84%) who completed the double-blind portion of the trial. Demographic and baseline disease characteristics of the study participants are shown in Table 1. A majority of the patients in the study were women (60%) and white (90%); the average age was 49 years old and back pain (60%) was reported as the primary pain condition. The mean daily baseline oral morphine-equivalent opioid dose was 222 mg. Descriptive statistics for the PAC-SYM and pain intensity scores at baseline are presented in Table 2. At baseline, the average scores for abdominal symptoms, rectal symptoms, and the PAC-SYM global score were in the mild to moderate severity range, whereas the average scores for stool symptoms were in the moderate to severe range across all treatment groups. PAC-SYM global score and pain intensity score mean values at baseline were similar for the three treatment arms. On Day 14, data were missing for approximately 12% of cases in treatment groups and selleck chemical 5% of cases in the placebo group. For PAC-SYM global score on Day 14, the methylnaltrexone 12 mg QD group showed an improvement of 0.56 (29.5%) from baseline, compared with an improvement of 0.32 (17.8%) for placebo (between-group difference P