Table 3 Clinical outcomes in the modified intention-to-treatment (MITT) and validated per protocol (VPP) populations
| Â | CTRX | ABPC/SBT | Risk Difference % (95% CI) | p-value |
|---|---|---|---|---|
MITT population, n | 124 | 139 | Â | Â |
Treatment period, days±SD | 7.8 ± 3.2 | 8.2 ± 3.7 |  | 0.245* |
 Day 4, effective, n (%) | 106 (88) (121 cases) | 130 (96) (135 cases) | −8.7 (−15.4–-2.0) | 0.011 |
 Day 7, effective, n (%) | 105 (88) (120 cases) | 126 (97) (130 cases) | −9.4 (−16.0–-2.8) | 0.007 |
 EOT, effective, n (%) | 108 (87) | 130 (94) | −7.1 (−14.2–0.0) | 0.055 |
 EOS, cure, n (%) | 102 (83) | 126 (91) |  | 0.187 |
 EOS, relapse, n (%) | 5 (4.0) | 3 (2) |  | |
 EOS, failure, n (%) | 17 (14) | 10 (7) |  | |
 Death within 30 days, n (%) | 4 (3) | 0 (0) | 3.2 (0.1–6.3) | 0.048†|
 VPP population, n | 104 | 108 |  |  |
Treatment period, days±SD | 7.9 ± 2.9 | 8.3 ± 3.3 |  | 0.387* |
 Day 4, effective, n (%) | 95 (91) | 105 (97) | −5.9 (−12.1–0.4) | 0.079†|
 Day 7, effective, n (%) | 94 (90) | 105 (97) | −6.8 (−13.3–-0.4) | 0.047†|
 EOT, effective, n (%) | 94 (90) | 104 (96) | −5.9 (−12.6–0.8) | 0.072†|
 EOS, cure, n (%) | 89 (86) | 102 (94) |  | 0.053 |
 EOS, relapse, n (%) | 5 (5) | 1 (1) |  | |
 EOS, failure, n (%) | 10 (10) | 5 (5) |  | |
 Death within 30 days, n (%) | 1 (1) | 0 (0) | 1.0 (−0.9–2.8) | 0.491†|