Table 2

Main outcome. clinical improvement 6 months after treatment start as measured by difference in clinical composite sum score from baseline to 6 months

PopulationMean improvement (95% CI)
2 weeks treatment
Mean improvement (95% CI)
6 weeks treatment
P valueMean difference (95% CI)
Intention to treat6.4 (5.5 to 7.2)6.4 (5.6 to 7.2)0.990.06 (−1.2 to 1.2)
Per protocol6.3 (5.6 to 7.1)6.7 (6.0 to 7.4)0.51−0.4 (−1.4 to 0.7)