References
TEAEs
EVENTS, EVENT
CONSORT flow diagram. Ninety-eight people were assessed for eligibility, of which 75 were randomized to one of three treatment arms: High dose (7 g Resistant potato starch (RPS) per day), low dose (3.5 g RPS per day), or placebo (Corn starch). Full analysis set (FAS) and per protocol (PP) populations are indicated, including reasons for participant attrition.Increases in the relative abundance of Increases in the relative abundance of Baseline demographic data for the FAS population.Age, sex, race, ethnicity, height, weight, and body mass index (BMI) for full analysis set (FAS) participants at baseline. Study visits and timeline of events.Visit number, corresponding event, and respective day number for the major activities during the trial.Baseline Bristol Stool Chart (BSC) scores.Baseline (BSC) scores for all bowel movements recorded during the run-in period (15–17 days, depending on the participant).The presence of bowel movements scored according to the Bristol Stool Chart (BSC) at 4 weeks in the 3.5 g RPS and placebo arms.The last seven bowel movements recorded for each participant (corresponding with a 4-week timepoint) were scored according to the BSC and compared between the 3.5 g RPS and Placebo treatment groups using Fisher’s exact test.Presence of bowel movements scored according to the Bristol Stool Chart (BSC) at 4 weeks in the 7 g RPS and placebo arms.The last seven bowel movements recorded for each participant (corresponding with a 4-week timepoint) were scored according to the BSC and compared between the 7 g RPS and Placebo treatment groups using Fisher’s exact test.Summary of TEAEs in the FAS population.