Table 2. Stool Frequency in ITT Population.
| Bowel movement type | No. per week, mean (SD) | MMRM analysis, LSM (95% CI) | P valuea | |||
|---|---|---|---|---|---|---|
| HN019 group (n = 112) | Placebo group (n = 117) | Change (week 8 − week 0) | HN019 vs placebo | |||
| HN019 group (n = 112) | Placebo group (n = 117) | |||||
| Complete spontaneous | ||||||
| Baseline (visit 3, wk 0) | 0.73 (0.98) | 0.81 (1.03) | 0.80 (0.54 to 1.05) | 0.66 (0.41 to 0.90) | 0.14 (−0.17 to 0.45) | .37 |
| End of study (visit 5, wk 8) | 1.58 (1.58) | 1.50 (1.66) | ||||
| Change (wk 8 − wk 0) | 0.85 (1.39) | 0.68 (1.54) | ||||
| Spontaneous | ||||||
| Baseline (visit 3, wk 0) | 2.53 (1.46) | 2.51 (1.34) | 0.49 (0.25 to 0.74) | 0.45 (0.21 to 0.68) | 0.05 (−0.25 to 0.34) | .76 |
| End of study (visit 5, wk 8) | 3.00 (1.36) | 2.95 (1.62) | ||||
| Change (wk 8 − wk 0) | 0.47 (1.38) | 0.44 (1.47) | ||||
| Any | ||||||
| Baseline (visit 3, wk 0) | 2.57 (1.44) | 2.54 (1.34) | 0.46 (0.21 to 0.70) | 0.42 (0.18 to 0.65) | 0.04 (−0.26 to 0.34) | .78 |
| End of study (visit 5, wk 8) | 3.01 (1.35) | 2.95 (1.62) | ||||
| Change (wk 8 − wk 0) | 0.44 (1.36) | 0.41 (1.50) | ||||
Abbreviations: ITT, intention to treat; LSM, least square mean; MMRM, mixed model for repeated measurements.
a
Estimated from MMRM model.