Sample size and Power calculation Assuming a baseline overall morbidity of 5% for both 4PC and SPC group (average morbidity based on specific literature) and considering a level of difference considered clinically significant of 0.05 (4.75 to 5.25%) for SPC to be non-inferior, with a β-error of 0.2 and α-error of 0.05, 300 patients are needed per randomization group.