Sample size
A sample size of 50 patients in two arms (a total of 100 patients) was deemed sufficient for detection of an 11-point difference on the AFEQT with an expected standard deviation of 20, a power of 80% and a significance level of 0.05. Calculation was based on a two-sided independent two-sample t-test. When measuring HRQoL from a patient perspective an 6–19 point increase has been deemed to reflect a meaningful improvement in HRQoL measured by the AFEQT [