Table 2.

Primary Endpoint Results

	Hydroxyurea				Placebo				Difference1 (95% CI)	Effect Size	p-value*
	no.	N‡	%		no.	N‡	%
Decreased Spleen Function at Exit (Compared with Baseline)	19	70	27		28	74	38		−11% (−26, 5)	− 28%	0·21
									Difference2 (95% CI)	Effect Size	p-value§
	N^	Entry	Exit	%Diff	N^	Entry	Exit	%Diff
DTPA GFR -- mL/min/1·73m2 (mean values)	67	123	146	18	66	125	146	17	2 (−16, 20)	0·04	0·84

^‡N: excludes subjects who had absent uptake at entry or who did not have exit spleen scan results.

Difference in the proportion of evaluable subjects with decreased splenic function in the Hydroxyurea group vs. the Placebo group.

^*p-value is from Fisher’s exact test comparing distributions between the two treatment groups.

^{^}N: Total number of subjects evaluated for each endpoint. N differs from number reported in Table 1, because only entry values that are paired with exit values (from the same subject) are included.

Difference in the mean increase in DTPA GFR in the Hydroxyurea group vs. the Placebo group.

^§p-value is from a t-test statistic comparing the exit versus entry difference in means between the two treatment groups.

CI = Confidence Interval