Anxiety and depression
SECONDARY
At 6 months the mean difference between the two study arms was less than the minimal clinically important difference assumed in the sample size calculation for both co-primary outcomes (HADS-A mean difference −0.60, 95% CI −1.40–0.21; and HADS-D mean difference −0.66, 95% CI −1.39–0.07) and the limits of the 95% confidence interval effectively ruled out any clinically important effects (Primary and secondary outcomes according to treatment armData are presented as mean±