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. Author manuscript; available in PMC: 2018 Nov 1.
Published in final edited form as: Gastroenterology. 2017 Jul 29;153(5):1240–1250.e2. doi: 10.1053/j.gastro.2017.07.035

Table 3.

Composite and individual symptom scores over 12 weeks: longitudinal analysis of reduction from baseline in arbitrary AUC (area under the curve relative to baseline expressed as positive values) units. (Pbo = placebo)

Symptom Mean + SD Placebo, N=88 10 μg RM, N=86 30 μg RM, N=91 100 μg RM, N=63
4-Symptom Composite 318.1 ±546.9 501.0 ±402.4 544.0 ±577.5 554.3 ±541.4
LS Mean Δ from Pbo   183.51 231.77 209.48
95% CI of difference   24.11; 342.92   74.58; 388.96   35.68; 383.27
P-value 0.02 <0.01 <0.02
Nausea 94.9 ±161.2 128.0 ±145.6 149.9 ±157.8 152.0 ±157.6
LS Mean Δ from Pbo 34.32 57.01 50.38
95% CI of difference   −9.19; 77.83   14.11; 99.92   2.98; 97.77
P-value 0.12 <0.01 0.04
Post-prandial Fullness 67.3 ±139.9   118.2 ±142.0   124.1 ±150.3   126.7 ±143.9
LS Mean Δ from Pbo 53.72 57.28 54.44
95% CI of difference   11.64 ; 95.80   15.81; 98.75   8.60; 100.29
P-value <0.01 <0.01 0.02
Abdominal Pain 81.7 ±148.3 127.4 ±141.1 133.3 ±151.9 145.2 ±140.1
LS Mean Δ from Pbo 43.09 54.42 56.47
95% CI of difference   1.18 ; 84.99   13.09; 95.74   10.79; 102.15
P-value 0.04 <0.01 0.02
Bloating 74.2 ±148.4 127.4 ±139.0 136.6 ±150.0 130.3 ± 142.5
LS Mean Δ from Pbo 52.18 63.21 48.39
95% CI of difference   10.51; 93.86   22.12; 104.31   2.94; 93.84
P-value <0.01 <0.01 0.04