Table 2 Intention-to-treat and per-protocol analyses over 12 weeks, overall and by age.
N events, initiators | N events, non-initiators | Absolute risk, initiators % (95% CI) | Absolute risk, non-initiators % (95% CI) | Risk difference % (95% CI) | Risk ratio (95% CI) | |
|---|---|---|---|---|---|---|
Intention-to-treata | ||||||
Overall | 207 | 323 | 0.44 (0.37,0.50) | 0.29 (0.26,0.32) | 0.15 (0.07,0.22) | 1.50 (1.25,1.80) |
6–17 years | 47 | 67 | 2.26 (1.04,3.48) | 0.78 (0.58,0.97) | 1.48 (0.26,2.71) | 2.90 (1.72,4.91) |
18–24 years | 76 | 76 | 0.73 (0.54,0.92) | 0.46 (0.34,0.57) | 0.27 (0.05,0.49) | 1.59 (1.11,2.28) |
25–39 years | 54 | 94 | 0.26 (0.19,0.33) | 0.21 (0.17,0.25) | 0.05 (−0.04,0.13) | 1.22 (0.86,1.73) |
40–49 years | 18 | 45 | 0.14 (0.07,0.21) | 0.21 (0.14,0.28) | −0.07 (−0.17,0.03) | 0.67 (0.36,1.25) |
50–59 years | 12 | 41 | 0.16 (0.04,0.28) | 0.24 (0.16,0.31 | −0.08 (−0.21,0.06) | 0.67 (0.31,1.45) |
Per-protocolb | ||||||
Overall | 188 | 305 | 0.47 (0.34,0.60) | 0.28 (0.23,0.34) | 0.19 (0.05,0.33) | 1.69 (1.20,2.36) |
6–17 years | 45 | 61 | 2.41 (0.92,3.90) | 0.72 (0.41,1.04) | 1.69 (0.17,3.20) | 3.34 (1.59,7.00) |
18–24 years | 72 | 70 | 0.85 (0.50,1.21) | 0.42 (0.25,0.60) | 0.43 (0.03,0.83) | 2.01 (1.12,3.60) |
25–39 years | 48 | 93 | 0.27 (0.13,0.40) | 0.21 (0.14,0.29) | 0.05 (−0.11,0.21) | 1.24 (0.65,2.35) |
40–49 years | 15 | 42 | 0.14 (0.03,0.25) | 0.20 (0.09,0.31) | −0.07 (−0.22,0.09) | 0.68 (0.25,1.84) |
50–59 years | 8 | 39 | 0.12 (−0.02,0.26) | 0.23 (0.10,0.36) | −0.11 (−0.30,0.08) | 0.53 (0.14,2.04) |