Variable | Group | Per protocol | ITT* | |||||
---|---|---|---|---|---|---|---|---|
Intervention (N = 69) | Control (N = 50) | RR (95%CI) | RD (95%CI) | RR (95%CI) | RD (95%CI) | |||
Alt | Baseline | Normal | 0 | 0 | - | - | - | - |
Abnormal | 70 (50) | 70 (50) | - | - | - | - | ||
Month 3 | Normal | 8 (89) | 1 (11) | - | - | - | - | |
Abnormal | 61 (44.55) | 49 (55.45) | 0.90 (0.82, 0.99) | -0.10 (-0.18, -0.01) | 0.16 (0.02, 1.29) | -0.10 (-0.18, -0.01) | ||
Month 6 | Normal | 20 (95.24) | 1 (4.76) | - | - | - | ||
Abnormal | 49 (50) | 49 (50) | 0.72 (0.62, 0.84) | -0.27 (-0.38, -0.16) | 0.05 (0.006, 0.38) | -0.27 (-0.38, -0.16) | ||
Ast | Baseline | Normal | 15 (30.61) | 34 (69.39) | - | - | - | - |
Abnormal | 54 (60) | 36 (40) | - | - | - | - | ||
Month 3 | Normal | 44 (58.67) | 31 (41.33) | - | - | - | - | |
Abnormal | 25 (57) | 19 (43) | 0.95 (0.59, 1.53) | -0.02 (-0.19, 0.15) | 0.93 (0.45, 1.9) | -0.02 (-0.19, 0.15) | ||
Month 6 | Normal | 59 (65.56) | 31 (34.44) | - | - | - | ||
Abnormal | 10 (34.48) | 19 (65.52) | 0.38 (0.19, 0.75) | -0.24 (-0.39, -0.08) | 0.28 (0.12, 0.67) | -0.23 (-0.38, -0.08) | ||
Alkp | Baseline | Normal | 7 (100) | 0 | - | - | - | - |
Abnormal | 62 (60) | 50 (40) | - | - | - | - | ||
Month 3 | Normal | 10 (100) | 0 | - | - | - | - | |
Abnormal | 59 (54) | 50 (46) | 0.86 (0.77, 0.94) | -0.14 (-0.23, -0.06) | 0.90 (0.88, 0.92) | -0.10 (-0.12, -0.08) | ||
Month 6 | Normal | 8 (100) | 0 | - | - | - | - | |
Abnormal | 61 (55) | 50 (45) | 0.88 (0.81, 0.96) | -0.12 (-0.19, -0.04) | 0.88 (0.86, 0.91) | -0.11 (-0.14, -0.09) | ||
GGT | Baseline | Normal | 22 (31) | 49 (70) | - | - | - | - |
Abnormal | 47 (69.12) | 21 (30.38) | - | - | - | - | ||
Month 3 | Normal | 49 (57) | 37 (43) | - | - | - | - | |
Abnormal | 20 (60.61) | 13 (39.39) | 1.11 (0.61, 2.02) | 0.03 (-0.13, 0.19) | 1.16 (0.51, 2.63) | 0.03 (-0.13, 0.19) | ||
Month 6 | Normal | 58 (61) | 37 (39) | - | - | - | - | |
Abnormal | 11 (54) | 13 (46) | 0.61 (0.30, 1.25) | -0.10 (-0.25, 0.05) | 0.54 (0.22, 1.33) | -0.10 (-0.25, 0.05) |