Chapter 6 152 numeric and non-normal variables and frequency (percentages) for categorical variables. A paired t test and Wilcoxon signed rank was used to compare continuous variables within groups. McNemar was used to compare categorical variables within groups. Comparison between groups for continuous variables was made by repeated measure analysis of variance using a mixed model after transformation of the data to enhance normality, with treatment, time (categorical) and their interaction as fixed effects and with random patient effects. In addition, data at each time point were compared with independent samples t tests, Mann-Whitney U test and Chi-square test depending on the variables. All p values were two-tailed and statistical significance was taken as a p value of less than 0.05. Multiple imputation for incomplete records was not needed because less than 5% of the data was missing. An interim analysis was not performed for this study. Results Between 10 December 2018 and 13 July 2021, 155 patients with CAF were found eligible. 140 patients, 68 men (48.6%) and 72 women (51.4%) with a mean age of 44.5 ±11.1 (range 19-79) years were randomized to PFPT (n=70) or a control group (postponed PFPT) (n=70). Baseline characteristics were similar between the 2 groups (Table 1). After randomisation, one patient in the PFPT group and 2 patients in the control group withdrew after inclusion. During the study, 4 patients were lost of follow-up at 8 weeks, one patient in the PFPT group and 3 in the control group. At 20 weeks after inclusion, 4 patients were lost of follow-up in the PFPT- group and 4 in the control group (Figure 1. CONSORT diagram). There were no reported negative side effects or serious adverse events in both groups.
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