Statistical analyses
RECRUITMENT
As this was an explorative clinical trial, no sample size calculation was performed. A total of 120 patients (30 per intervention group) were considered logistically manageable and sufficient to achieve the study's exploratory objectives. Because of insufficient recruitment, the statistical analyses were changed: Instead of analysis of covariance, data were analyzed only descriptively using mean values, standard deviations (SDs), medians, absolute and relative frequencies, and graphically using boxplots. Baseline values were calculated for the whole allocated population and for the Full Analysis Set (FAS) including patients who could be analyzed also at the 8-week follow-up. Missing data were not imputed. Statistical analyses were performed with IBM SPSS for Mac Version 26, IBM SPSS for Windows Version 27.