Sample Size
Sample size calculations were conducted before the trial and were based on between-group differences in the change in primary outcomes. The significance level was Bonferroni corrected for a clinically meaningful between-group mean difference of 12% on the QOLIBRI overall scale (with an estimated SD of 20%) and a between-group mean difference of 1.8 on the PART-O (with an estimated SD of 3.0). Thus, with equal randomization to treatment groups, power of 80%, and a significance level of α = .025 (correcting for 2 primary outcomes), the sample size was calculated as 55 patients in each group for both primary outcomes. Allowing for an attrition rate of 10%, 60 participants were included in each treatment group. Sample size calculations were performed using G*Power software, version 3 (Faul et al