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Efficacy and safety of peppermint oil in IBS 167 7 Table S7.3 Responder endpoints (PP-population). Placebo N =59 Small-intestinal release Peppermint oil N =55 Ileocolonic release Peppermint oil N =56 No. responders (%) No. responders (%) P- value Odds Ratio (95% CI) No. responders (%) P- value Odds Ratio (95% CI) Primary endpoints Abdominal Pain ¶ Global Relief ‡ 21 (35.6) 3 (5.1) 25 (45.5) 6 (10.9) 0.335 0.243 1.46 (0.68 - 3.15) 2.44 (0.55 – 10.89) 26 (46.4) 1 (1.8) 0.204 0.359 1.64 (0.76 - 3.53) 0.34 (0.03 – 3.42) The per-protocol-population included all randomly assigned patients who had at least 80% adherence to treatment and had completed the treatment period. P- values, ORs and corresponding two-sided 95% CIs were calculated using multiple logistic regression adjusted for minimization variables. ¶ 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).
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