Table 7.

Safety Evaluation – Analysis of Clinical Chemistry Parameters

Parameter	Visit	Group A (N=18) VISPO-Oral		Group B (N=19) Placebo-Oral		Group C (N=18) VISPO-Topical		Group A (N=18) Placebo-Topical
AST (U/L)	Baseline	26.44±15.33	0.311#	24.95±10.16	0.091	22.22±7.18	0.836#	24.28±9.58	0.065
	Week 16	27.61±15.26		21.53±4.13		21.94±10.65		29.06±15.59
	Change	1.17±4.74		−3.42±8.36		−0.28±5.60		4.78±10.28
ALT (U/L)	Baseline	29.17±15.43	0.731#	24.05±12.88	0.149	22.61±12.98	0.332#	27.00±14.00	0.684
	Week 16	28.44±15.45		21.11±8.36		21.22±10.90		26.50±12.03
	Change	−0.72±8.75		−2.95±8.53		−1.39±5.90		−0.50±5.12
Serum creatinine (mg/dL)	Baseline	0.91±0.24	<0.001#***	0.90±0.14	<0.001#***	0.85±0.16	0.012#*	0.88±0.15	<0.001#***
	Week 16	0.84±0.22		0.81±0.14		0.78±0.19		0.81±0.16
	Change	−0.07±0.07		−0.09±0.09		−0.06±0.10		−0.07±0.06
BUN (mg/dL)	Baseline	10.07±3.02	0.295#	9.44±2.06	0.535	10.15±3.26	0.549	8.62±2.58	0.311
	Week 16	9.37±2.54		9.05±2.36		9.71±2.94		9.27±2.31
	Change	−0.70±2.75		−0.40±2.73		−0.44±3.06		0.65±2.64

Notes: Values are mean±SD. ^#Paired t-test; *p<0.05 and ***p<0.001.

Abbreviations: N, number of subjects; AST, Aspartate aminotransferase; ALT, Alanine aminotransferase; BUN, Blood urea nitrogen.