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Efficacy and safety of peppermint oil in IBS 149 7 Table 7.1 Summary of patient demographic and baseline characteristics (ITT-population). Placebo Small-intestinal release Peppermint oil Ileocolonic release Peppermint oil N =64 N =62 N =63 Demographic data Age , years Mean (SD) Range 35.5 (15.2) 19-70 32.0 (11.1) 18-66 34.4 (13.1) 18-64 Sex , N (%) Female Male 49 (76.6) 15 (23.4) 51 (82.3) 11 (17.7) 47 (74.6) 16 (25.4) Race , N (%) Caucasian Mixed ¶ 63 (98.4) 1 (1.6) 60 (96.8) 2 (3.2) 58 (92.1) 5 (7.9) BMI , mean (SD) 24.6 (5.2) 25.6 (5.7) 26.5 (5.1) Educational level , N (%) No education Low Moderate High 0 0 32 (50.0) 32 (50.0) 0 4 (6.5) 23 (37.1) 35 (56.5) 1 (1.6) 11 (17.5) 25 (39.7) 26 (41.3) Employment status , N (%) Currently studying Employed, full- or part-time Unemployed Incapacitated for work Homemaker Retired 12 (18.8) 41 (64.1) 3 (4.7) 2 (3.1) 1 (1.6) 5 (7.8) 10 (16.1) 40 (64.6) 3 (4.8) 4 (6.5) 4 (6.5) 1 (1.6) 10 (15.9) 40 (63.5) 4 (6.3) 7 (11.1) 2 (3.2) 0 Setting , N (%) Primary care Secondary care Combined secondary & tertiary care 39 (60.9) 16 (25.0) 9 (14.1) 36 (58.1) 14 (22.6) 12 (19.4) 34 (54.0) 11 (17.5) 18 (28.6) IBS-subtype , N (%)‡ Diarrhea Constipation Mixed Undefined 29 (45.3) 14 (21.9) 12 (18.8) 9 (14.1) 25 (40.3) 12 (19.4) 15 (24.2) 10 (16.1) 29 (46.0) 16 (25.4) 13 (20.6) 5 (9.7) Abdominal symptoms , mean (SD) Abdominal pain § Abdominal discomfort ± Abdominal bloating ± Abdominal cramping ± Belching ± Nausea ± 5.3 (1.3) 6.3 (1.4) 6.4 (1.8) 6.2 (1.8) 3.3 (2.5) 3.0 (2.4) 5.5 (1.2) 6.4 (1.3) 6.4 (2.0) 6.0 (2.1) 3.5 (2.4) 3.5 (2.7) 5.4 (1.4) 6.5 (1.2) 6.7 (1.9) 6.3 (1.6) 3.3 (2.7) 3.7 (2.5) Bowel symptoms , mean (SD) Urgency ± 6.2 (1.7) 6.3 (1.7) 6.6 (1.6) IBS severity † Mean score (SD) Mild, N (%) Moderate, N (%) Severe, N (%) 270.8 (74.2) 7 (10.9) 34 (53.1) 23 (35.9) 277.0 (73.6) 3 (4.8) 35 (56.5) 24 (38.7) 281.8 (68.7) 5 (7.9) 31 (49.2) 27 (42.9)

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