A double-blind clinical trial to compare the efficacy and safety of a multiple amino acid-based ORS with the standard WHO-ORS in the management of non-cholera acute watery diarrhea in infants and young children: “VS002A” trial protocol

Table 3 Duration of diarrhea (days^a,b)

Study	M_t	SD_t	M_p	SD_p	Mdiff	%diff	SDpooled	ES	20%_diff	ES	nreq	nact	%op
Cojocaru^a	4.05	1.48	5.73	1.77	1.68	29.3	1.62	1.0	1.14	.71	32	132	99
Santos^b	4	2.1	4.7	2.2	0.7	14.9	2.15	0.3	0.94	0.44	81	132	99

Mt mean of treatment, SDt standard deviation of treatment, Mp mean of placebo, SDp standard deviation of placebo, Mdiff mean difference between treatment and placebo, %diff percentage of mean difference between treatment and placebo, SDpooled pooled standard deviation, ES effect size (Mdiff/SDpooled), 20%diff units for 20% difference from placebo, ES effect size (20% units difference/SDpooled), nreq sample size required (alpha 0.05, beta 0.20), nact actual sample size planned for PR-17028, %op percentage observed power (relative to desired minimum of 80%); note – primary study outcome exceeds power criterion
^aCojocaru et al. (2002)
^bSantos et al. (2000)

ISSN: 1745-6215