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Chapter 7 184 Table S7.10 Primary endpoints per healthcare setting (ITT-population). Placebo N =64 Small-intestinal release Peppermint oil N =62 Ileocolonic release Peppermint oil N =63 No. responders (%) No. responders (%) P- value Odds Ratio (95% CI) No. responders (%) P- value Odds Ratio (95% CI) Primary endpoints Abdominal pain ¶ Primary care Secondary/tertiary care Global relief ‡ Primary care Secondary/tertiary care 12/39 (30.8) 10/25 (40.0) 1/39 (2.6) 2/25 (8.0) 15/36 (41.7) 14/26 (53.8) 3/36 (8.3) 3/26 (11.5) 0.393 0.333 0.213 0.946 1.53 (0.58 – 4.08) 1.83 (0.54 – 6.25) 5.15 (0.39 – 68.0) 1.08 (0.12 – 9.50) 16/34 (47.1) 10/29 (34.5) 1/34 (2.9) 0/29 (0) 0.206 0.772 0.695 N.A. 1.89 (0.71 – 5.07) 0.83 (0.23 – 3.01) 1.83 (0.09 – 37.23) N.A. ¶ 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 (FDA- recommendation); ‡ A responder was defined as a patient with at least a global relief score of 6 or 7 (on a 7-point NRS) in at least 50% of weeks in which treatment was given (EMA-recommendation).