SAMPLE SIZE and STATISTICAL considerations. This feasibility pilot trial is focused at site and investigator level and it is not required to provide power calculation. However, this study must be seen in the context of the future Phase II trial that should result from it, as pilot trial size can impact the overall sample size across both the main and pilot trials combined. The trial sample size of 25 patients per arm (50 patients in total) was selected according Whitehead et al., and it could give investigators the additional advantage of calculating the standardized variance of our secondary endpoints if a medium experimental effect size is observed.