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Main outcome. clinical improvement 6 months after treatment start as measured by difference in clinical composite sum score from baseline to 6 months
| Population | Mean improvement (95% CI) 2 weeks treatment |
Mean improvement (95% CI) 6 weeks treatment |
P value | Mean difference (95% CI) |
| Intention to treat | 6.4 (5.5 to 7.2) | 6.4 (5.6 to 7.2) | 0.99 | 0.06 (−1.2 to 1.2) |
| Per protocol | 6.3 (5.6 to 7.1) | 6.7 (6.0 to 7.4) | 0.51 | −0.4 (−1.4 to 0.7) |
