Sample size and power
This study implemented a non-inferiority trial. A non-inferiority trial is a type of clinical research study that aims to demonstrate that a (new) treatment is not worse than an existing treatment by a prespecified margin. Because the non-inferiority margin for CAPS-CA-5 scores had not yet been determined at the start of this study, we used the article published by Sloan et al. [For the estimation of the sample size (for 80 percent power and type 1 error of 2,5 percent) the following formula is used [According to this formula, 36,5 participants per arm are required. As in the previous sample size calculation, we used the baseline variables as covariates. Based on Borm et al. [