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Chapter 7 166 the Schwarz’s Bayesian Criterion (smaller values indicate a better fit). Estimated means (standard error, SE) per time-point, P- values, and 95% CIs are reported. A multiplicity correction was applied according to the following principle: for each secondary outcome measure, two comparisons are made to placebo (one for small- intestinal release peppermint oil and one for ileocolonic release peppermint oil). Assuming the chance of 5% for a type 1 error for a single comparison, a two-sided P - value ≤ 0.025 was considered statistically significant for secondary outcome analyses. Secondary outcomes were exploratory in nature. Table S7.1 Adherence to study medication and compliance to the digital symptom diary (ITT-population). Placebo Small-intestinal release Peppermint oil Ileocolonic release Peppermint oil N =64 N =62 N =63 Adherent to study medication ¶ Number of patients (%) 62 (96.9) 56 (90.3) 58 (92.1) Compliance rate to the digital symptom diary ± Mean % (SE) 87.2 (1.47) 88.3 (1.09) 85.3 (1.48) ¶ Adherence to study medication was quantified by counting returned capsules at the study end-visit. Patients were deemed adherent if at least 80% of study medication was taken during the complete treatment period or until discontinuation. There were no significant differences in adherence between placebo and small-intestinal, or ileocolonic release peppermint oil, P =0.212 and P =0.333, respectively; ± Compliance rate to the digital diary was defined by the percentage of entry days completed during the complete treatment period or until discontinuation. There were no significant differences between placebo and small-intestinal release, or ileocolonic release peppermint oil, P =0.405 and P =0.285, respectively. Table S7.2 Number needed to treat and number needed to harm (ITT-population). Small-intestinal release Peppermint oil Ileocolonic release Peppermint oil N =62 N =63 Number needed to treat Based on primary abdominal response outcome ¶ Based on moderate global relief outcome § 8.1 5.4 14.5 N.A. Number needed to harm Based on AE prompting discontinuation 30 15 ¶ A responder was defined as a patient with at least 30% decrease in mean worst daily abdominal pain in at least 50% of weeks in which treatment was given; § A responder was defined as a patient with at least a global relief score of 5, 6, or 7 (on a 7-point NRS) in at least 50% of weeks in which treatment was given. AE Adverse Event.