TABLE 4.

An analysis of levels of AST and ALT as well as the ratio of AST/ALT by visit (PP set).

Parameters	Treatment	Test		Placebo		P-value
		No.	Mean ± SD	No.	Mean ± SD
AST (GOT, IU/L)	Baseline	37	32.70 ± 11.84	43	32.63 ± 15.37	0.3982 b
	6 weeks	37	27.59 ± 8.07	43	34.09 ± 25.06
	Change from baseline	37	-5.11 ± 10.97	43	1.47 ± 26.10	0.1839 b
	P-value		0.0075 c		0.1585 d
	12 weeks	37	25.92 ± 7.98	43	31.47 ± 20.49
	Change from baseline	37	-6.78 ± 8.26	43	-1.16 ± 18.96	0.0365 b
	p-value		<0.0001 c		0.1655 d
ALT (GPT, IU/L)	Baseline	37	44.95 ± 29.34	43	40.95 ± 25.95	0.5366 b
	6 weeks	37	35.97 ± 20.76	43	38.65 ± 22.83
	Change from baseline	37	-8.97 ± 17.98	43	-2.30 ± 15.41	0.2329 b
	P-value		0.0044 c		0.0865 d
	12 weeks	37	33.16 ± 17.75	43	39.42 ± 28.23
	Change from baseline	37	-11.78 ± 21.38	43	-1.53 ± 19.61	0.0230 b
	P-value d		0.0002		0.5110
AST/ALT ratio	Baseline	37	0.85 ± 0.27	43	0.90 ± 0.31	0.5856 b
	6 weeks	37	0.91 ± 0.33	43	0.95 ± 0.37
	Change from baseline	37	0.06 ± 0.22	43	0.05 ± 0.33	0.8169 b
	P-value d		0.3079		0.3649
	12 weeks	37	0.89 ± 0.32	43	0.90 ± 0.30
	Change from baseline	37	0.04 ± 0.27	43	0.00 ± 0.24	0.4553 a
	P-value c		0.3601		0.9663

AST, aspartate aminotransferase; GOT, glutamic oxaloacetic transaminase; ALT, alanine aminotransferase; GTP, glutamate pyruvate transaminase.

^acompared with the placebo group (two sample t-test).

^bcompared with the placebo group (Wilcoxon rank sum test).

^ccomparisons within groups (paired t-test).

^dcomparisons within groups (Wilcoxon signed rank test).