Table 2.

Analysis of proportion of subjects with clinical improvement (clinical status) from Day 0 to Day 8, Day 11 and Day 15, measured using the World Health Organization seven-point ordinal scale (modified intent-to-treat population).

Visit	Improvement	Pegylated IFN-α2b + SOC (N=119) n (%)	SOC (N=123) n (%)	P-value	Risk difference (%)	95% CI
Day 8		n=112	n=110
	Yes	90 (80.36)	75 (68.18)	0.0379	12.18	(0.46 to 23.74)
	No	22 (19.64)	35 (31.82)
Day 11		n=119	n=121
	Yes	109 (91.60)	112 (92.56)	0.7818	-0.97	(-8.38 to 6.42)
	No	10 (8.40)	9 (7.44)
Day 15		n=119	n=123
	Yes	112 (94.12)	118 (95.93)	0.5150	-1.82	(-8.16 to 4.14)
	No	7 (5.88)	5 (4.07)

IFN, interferon; SOC, standard of care; N, number of subjects on treatment; n, number of subjects with available data for treatment; CI, confidence interval.

Chi-squared test was used to calculate P-values, and 95% CI was calculated using risk difference.

Risk difference is defined as the difference [(pegylated IFN-α2b + SOC) - SOC)].

P<0.05 was considered to indicate statistical significance.