Table 3 Adverse events during the second year of the study

	Combination therapy group	Monotherapy group	p Value
>30% increase in creatinine vs baseline	11 (14)	2 (4)	0.046
Hypertrichosis	7 (10)	4 (6)	0.53
Dyspepsia	7 (10)	7 (10)	1
Sleeplessness	2 (3)	7 (10)	0.17
>10% decrease in serum albumin vs baseline	3 (4)	9 (13)	0.13

Number (%) of adverse events that occurred in >10% of patients in either treatment group. p Values were determined by Fisher exact test.