Sample size
TG
To detect a difference of TST of 10% compared to baseline value (considering a TST of 420 min), between the two groups, at T3, a Z-test with a type I error of 5% and a statistical power of 80% will be used. A total of 57 patients including 29 in CG and 28 in TG are required.Two interim analyses for the efficacy and futility using the Lan-Demets method (O’Brien Fleming boundaries) to estimate the alpha spending function will be performed at 33% and 66% of the information fraction (after enrolment of 19 and 38 evaluable patients). With 10% of non-evaluable patients, 64 patients should be randomized. The primary objective will be done in modified intention-to-treat (miTT): all randomized and evaluable patients for the TST at T0 and T3.