Each study participant will be assigned a study identification number. A CRF, containing the participant’s identification number and necessary baseline data, will be completed in paper form. All data will be checked for completeness, entered, and stored in a password-protected electronic database. All original copies of CRFs and all study data in paper form will be stored in a locker within the study site, available for the involved researchers only. Each CRF must be completed, checked for completeness of data, and signed by a researcher. Only the research team and person responsible for statistical analysis of the data will have access to the full trial dataset (blinded of any identifying participant).

All analyses will be conducted on an intention-to-treat basis, including all patients in the groups to which they are randomized for whom outcomes are available (including dropout and withdrawals). Per-protocol analysis also will be performed, in which all subjects who finish the study according to the protocol will be included.

Descriptive statistics will be used to summarize baseline characteristics. The Student t-test will be used to compare mean values of continuous variables approximating a normal distribution. For non-normally distributed variables, the Mann-Whitney U test will be used. The x2 test or Fisher exact test will be used, as appropriate, to compare percentages. The same computer software will be used to calculate the relative risk (RR), number needed to treat (NNT), and mean difference (MD), all with a 95% confidence interval (CI). The difference between study groups will be considered significant when the p value is < 0.05, when the 95% CI for RR does not include 1.0, or when 95% CI for MD does not include 0. All statistical tests will be two-tailed and performed at the 5% level of significance.

Both the primary and secondary outcomes will be analyzed by logistic regression, controlling for three, prespecified, potential confounding variables, i.e., age, sex, and subtype of IBS. The difference between study groups will be considered significant when the p value is < 0.05, when the 95% CI for RR (or odds ratio [OR]) does not include 1.0, or when 95% CI for MD does not include 0. All statistical tests will be two-tailed and performed at the 5% level of significance.

Every effort will be made to minimize missing baseline and outcome data. However, the amount of missing data will be reported for each study arm. The reasons for withdrawals, if feasible, will be compared qualitatively between groups. Multiple imputation methods for missing data will be included to address any missing data, as recommended [13, 30, 31].

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