Transfer of FRozen Encapsulated multi-donor Stool filtrate for active ulcerative Colitis (FRESCO): study protocol for a prospective, multicenter, double-blind, randomized, controlled trial

Table 1 Statistical power analysis

True rates [%]			Sample size per group (including dropouts)^a	Power for the respective test setting [%]
π_FMT	π_FMFT	π_Placebo	Sample size per group (including dropouts)^a	Global test^b	FMT and FMFT vs. placebo	FMT or FMFT vs. placebo
30	30	5	58	93	98	92
30	40	10	58	92	95	69 rsp 95
40	40	10	58	96	99	95

^aResulting in a total sample size would be 3 × 58 = 174, 3 × 93 = 279, and 3 × 50 = 150 patients to be randomized
^bThe increased power (i.e., a power larger than 80%) results from the inclusion of dropouts in the analysis

ISSN: 1745-6215