Table 2 Change in COWS scores across time in intention-to-treat population and without data imputation
Timepoint1 | Intention-to-Treat | Data Not Imputed | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
Mean (SD) Reduction | 95% CI | Percent Change | p-value2 | n | Mean (SD) Reduction | 95% CI | Percent Change | p-value3 | Percentage of Participants with Clinically Meaningful Reduction (n/N%)4 | |
30 minutes | 6.4 (4.2) | [3.9, 8.9] | 42.0% | < 0.0001 | 31 | 6.4 (4.2) | [3.9, 8.9] | 42.0% | < 0.0001 | 24 (77.4%) |
60 minutes | 7.0 (4.7) | [4.2, 9.7] | 45.9% | < 0.0001 | 31 | 7.0 (4.7) | [4.2, 9.7] | 45.9% | < 0.0001 | 26 (83.9%) |
120 minutes | 7.4 (4.3) | [4.9, 9.9] | 49.6% | < 0.0001 | 27 | 7.6 (4.3) | [5.3, 11.0] | 51.8% | < 0.0001 | 25 (92.6%) |
Day 2 | 7.5 (4.4) | [4.9, 10.0] | 50.0% | < 0.0001 | 20 | 8.1 (4.0) | [6.0, 12.0] | 56.3% | < 0.0001 | 19 (95.0%) |
Day 3 | 7.9 (4.1) | [5.5, 10.0] | 53.3% | < 0.0001 | 20 | 8.8 (3.4) | [7.2, 12.0] | 61.5% | < 0.0001 | 20 (100%) |
Day 4 | 8.1 (4.2) | [5.6, 11.0] | 54.5% | < 0.0001 | 15 | 9.9 (3.3) | [7.3, 12.0] | 66.2% | < 0.0001 | 16 (100%) |
Day 5 | 8.4 (5.0) | [5.5, 11.0] | 56.1% | < 0.0001 | 13 | 10.7 (4.9) | [6.5, 15.0] | 70.4% | < 0.0001 | 12 (92.3%) |