Statistical methods
SECONDARY
All patients that attended follow-up and completed the SF-36, VascuQoL and PSFS questionnaires were included in this exploratory superiority analysis comparing the three treatment strategies (WA, WA + HSEP and WA + SEP). For all outcomes, the full data set was used without any imputation and all analyses were based on the initial treatment assignment. The principal outcome measure in this secondary analysis was change in the SF-36 scores from baseline to one year. Other outcomes of interest were the change in the SF-36 scores from baseline to three and six months, respectively, and the change in the VascuQoL and the PSFS scores from baseline to three, six and 12 months. The primary analysis in the SUNFIT trial had a non-inferiority design, and the sample size was based on the primary hypothesis that HSEP would be non-inferior to SEP regarding 6MWT change, presented in detail elsewhere [