Table 2. Incidence of the Main Outcome Decrease in Body Mass Index of at Least 0.25 SDS at 6 Months of Follow-up^a.

Variable	ITT equal-case scenario (n = 54)	ITT worst-case scenario (n = 54)	PPA (n = 48)
Placebo event rate
No./total No.	15/27	15/27	13/25
Proportion (95% CI)	0.56 (0.37-0.74)	0.56 (0.37-0.74)	0.52 (0.32-0.72)
Butyrate event rate
No./total No.	26/27	22/27	22/23
Proportion (95% CI)	0.96 (0.89-1.03)	0.81 (0.67-0.96)	0.96 (0.87-1.04)
Absolute benefit increase (butyrate-placebo)b
Proportion (95% CI)	0.40 (0.21-0.61)	0.26 (0.02-0.49)	0.44 (0.22-0.64)
P value	<.001	.03	<.001
No. needed to treat, proportion (95% CI)c	2 (2-5)	4 (2-88)	2 (2-5)

Abbreviations: ITT, intention-to treat; PPA, per-protocol analysis.

^a Values are proportions from binomial regression (see Statistical Analysis for details). The ITT equal-case scenario analysis assumes the occurrence of the best outcome in 4 children lost to follow-up in the butyrate arm and in 2 children lost to follow-up in the placebo arm; the ITT worst-case scenario analysis assumes the occurrence of the worst outcome in 4 children lost to follow-up in the butyrate arm and the best outcome in 2 children lost to follow-up in the placebo arm.

^b Wald test used.

^c Values were obtained from the Bender formula.