| Intention-to-treat (ITT) analysis | Modified ITT analysis | ||
---|---|---|---|---|
 | NTZ | Placebo | NTZ | Placebo |
Number of children | 30 | 30 | 26 | 26 |
Sex (M:F) | 14:16 | 20:10 | 13:13 | 18:8 |
Age (months) | 20 (11.3) | 21 (20.2) | 21 (11.9) | 22 (17.8) |
CD4 count (cells/μL) | 579 (378) | 614 (403) | 583 (316) | 503 (394) |
Weight (kg) (mean, SD) | 7.2 (1.8) | 7.3 (2.0) | 7.3 (2.0) | 7.3 (2.0) |
Presence of oedema (number, %) | 6 (20) | 5 (17) | 5(19) | 4 (15) |
Hb (g/dL) (mean, SD) [range] | 8.7 (2.2) [4.9-12.8] | 8.3 (1.8) [4.5-13.1] | 8.3 (1.8) [5.8-11.9] | 8.2 (2.0) [4.5-13.1] |
WBC (×109/L) | 11.6 (6.2) [4.7-35] | 11.0 (5.1) [3.2-21.9] | 12.5 (6.7) [5.2-35] | 10.9 (5.1) [4.7-13.1] |
Na+ (mmol/L) | 137.2 (2.5) | 137.6 (1.9) | 137.3 (3.3) | 138.3 (1.0) |
K+ (mmol/L) | 4.4 (0.5) | 4.4 (0.5) | 4.5 (0.6) | 4.5 (0.5) |
Creatinine (μmol/L) | 95.5 (39.2) | 89.1 (38.3) | 95.6 (34.8) | 92.4 (38.2) |
Alkaline phosphatase (i.u./l) | 148 (72) | 164 (69) | 151 (77) | 168 (61) |
AST (i.u./l) | 62.1 (61) | 61 (22) | 54 (23) | 64 (22) |
ALT (i.u./l) | 45 (30) | 48 (25) | 45 (30) | 48 (26) |