Table 3 Cumulative incidence of infant skin and soft tissue infections at 3 months by study arm
| Â | Azithromycin n*/N (%; 95 CI) | Placebo N*/N (%; 95 CI) | Risk ratio (95% CI) | p-value | Risk difference (%) (95% CI) | p-value |
|---|---|---|---|---|---|---|
ITT analyses | ||||||
ITT population (complete case analysis), n = 1671 | 47/816 (5.8; 4.4–7.6) | 67/855 (7.8; 6.2–9.8) | 0.73 (0.51–1.06) | 0.098 |  − 2.1 (− 4.5–0.4) | 0.094 |
ITT population (multiple imputation), n = 2122 | (6.4; 4.6–8.2), N = 1059 | 8.1 (6.3–10.0), N = 1063 | 0.79 (0.54–1.13) | 0.20 |  − 1.7 (− 4.3–0.9) | 0.19 |
PP analyses | ||||||
PP population (complete case analysis), n = 908 | 22/435 (5.1; 3.3–7.6) | 36/473 (7.6; 5.5–10.4) | 0.66 (0.40–1.11) | 0.12 |  − 2.1 (− 4.5–0.4) | 0.094 |
PP population (multiple imputation), n = 1043 | (5.6; 3.3–7.8), N = 510 | (7.7; 5.3–10.1), N = 533 | 0.72 (0.43–1.19) | 0.20 |  − 2.2 (− 5.4–1.1) | 0.19 |