Table 2 Observed mean changes by visit month and treatment group for primary endpoints, ALT and HBa
End point | Multivitamin | Placebo | Two-sided p-value for change over timeb | ||
|---|---|---|---|---|---|
- n - | Mean (SD) | - n - | Mean (SD) | ||
Change in CD4 (cells/uL) | |||||
0–3 months | 194 | 77 (97) | 193 | 86 (103) | 0.726 |
0–6 months | 191 | 74 (95) | 190 | 94 (92) | |
0–12 months | 183 | 106 (112) | 188 | 117 (116) | |
0–18 months | 181 | 141 (160) | 186 | 147 (130) | |
Change in weight (kg) | |||||
0–3 months | 194 | 1.2 (2.9) | 195 | 1.2 (3.3) | 0.691 |
0–6 months | 191 | 2.1 (4.2) | 190 | 1.7 (4.0) | |
0–12 months | 183 | 3.2 (5.4) | 188 | 3.1 (5.0) | |
0–18 months | 181 | 3.9 (6.2) | 187 | 3.3 (5.8) | |
Change in QoL score | |||||
0–6 months | 191 | 6.1 (11.1) | 190 | 7.5 (12.7) | 0.454 |
0–12 months | 181 | 8.1 (10.9) | 187 | 8.4 (12.0) | |
0–18 months | 181 | 6.8 (12.4) | 186 | 8.8 (12.4) | |
Change in ALT (IU/I) | |||||
0–6 months | 190 | 0.99 (32.8) | 188 | −2.78 (20.9) | |
0–12 months | 183 | 0.56 (41.5) | 187 | −1.66 (22.1) | 0.064 |
0–18 months | 180 | −1.69 (33.4) | 186 | −0.02 (30.0) | |
Change in HB (g/dL) | |||||
0–6 months | 191 | 0.68 (1.6) | 190 | 0.60 (1.5) | |
0–12 months | 183 | 0.92 (1.4) | 188 | 0.81 (1.6) | 0.977 |
0–18 months | 181 | 1.01 (1.5) | 186 | 0.91 (1.7) | |