Statistical analysis
End points concerning HRQL presented in this study are exploratory as power calculations were based on PAS. Sample size to achieve a predicted power of 80% for a one-step change on the PAS with a standard deviation of 1.2 was calculated to 30 participants in each group including potential dropouts. Calculations were made using the Mann–Whitney All statistical analyses were performed using SAS version 9.4. For descriptive purposes, results are presented as mean, standard deviation, and 95% confidence intervals (CI) for continuous variables and as numbers and percentages for categorical variables. All tests performed were two-tailed non-parametric tests, with a significance level of The Fisher’s non-parametric permutation test was used to calculate mean differences between groups for continuous variables. Comparisons of differences within each group were made using the Fisher’s non-parametric permutation test for paired observations for continuous variables. Ordered categorical variables were calculated using the Mantel–Haenszel test, and non-ordered categorical using the Chi-square test. For dichotomous variables, the Fisher’s exact test was used.