Table 12. Liver and renal markers.

* Values at a 95% confidence interval where the level of significance, α= 0.05

The method of robust regression controlled for baseline differences with treatment group as a covariate has been used to testing differences between the treatment groups.

** Parameter not assessed on Day 28 as per the protocol; NA – Not Applicable

Parameter	Days of therapy	Gp 1			Gp 2			p-value	Estimate
		N	Mean	SD	N	Mean	SD
Aspartate transaminase	0	30	35.42	20.2	20	48.05	21.17	-	-
	14	24	17.09	5.7	18	19.06	8.9	0.58	1.12
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	17.69	8.84	9	18.22	6.02	0.22	-2.46
Alanine transaminase	0	30	27.27	15.3	20	36.75	23.65	-	-
	14	24	22.85	9.5	18	24.42	12.21	0.04*	-2.54
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	16.37	8.78	9	16.22	8.14	0.58	1.28
Alkaline phosphatase	0	29	69.21	28.1	20	91.15	30.15	-	-
	14	24	84.53	21.5	18	104.51	23.89	0.07	-11.51
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	83.06	26.60	9	84.44	26.02	0.94	-0.75
Direct Bilirubin	0	30	0.21	0.1	20	0.23	0.11	-	-
	14	24	0.22	0.1	18	0.21	0.1	0.79	0.01
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	0.18	0.06	9	0.19	0.14	0.09	0.04
Total Bilirubin	0	30	0.52	0.2	20	0.49	0.18	-	-
	14	24	0.53	0.3	18	0.52	0.18	0.52	-0.04
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	0.42	0.18	9	0.47	0.31	0.24	0.07
Urea	0	30	43.62	30.1	20	43.6	28.98	-	-
	14	25	30.48	11.5	18	34.78	12.15	0.21	-3.87
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	19.81	7.11	9	24.56	8.71	0.23	-4.24
Albumin	0	29	3.46	0.4	20	3.45	0.44	-	-
	14	24	3.88	0.3	18	3.61	0.44	0.02*	0.28
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	4.33	0.23	9	4.34	0.27	0.76	-0.03
Total Protein	0	29	6.9	0.6	20	7.19	0.6	-	-
	14	24	6.65	0.5	18	6.73	0.7	0.84	-0.04
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	6.86	0.40	9	7.28	0.32	0.01*	-0.46
Creatinine	0	30	1.08	0.9	20	1.01	0.37	-	-
	14	25	0.82	0.2	18	0.78	0.17	0.71	0.02
	28	NA**	NA**	NA**	NA**	NA**	NA**	NA**	NA**
	60	16	0.78	0.21	9	0.84	0.2	0.22	-0.08