TABLE 5.
The variances of AST and ALT levels in subgroups (ALT between 31 and 51 IU/L and gamma-GTP between 51 and 100 IU/L) by visit (PP Set).
| Parameters | Treatment | Test | Mean ± SD | Placebo | Mean ± SD | p-value |
|---|---|---|---|---|---|---|
| No. | No. | |||||
| AST (GOT, IU/L) | Baseline (visit 1) | 6 | 33.50 ± 4.55 | 11 | 29.27 ± 11.73 | |
| 6 weeks (visit 3) | 6 | 29.33 ± 4.72 | 11 | 43.09 ± 44.69 | ||
| Change from baseline | 6 | -4.17 ± 8.50 | 11 | 13.82 ± 47.44 | 0.552 | |
| p-value | 0.2834 | 0.9414 | ||||
| 12 weeks (visit 4) | 6 | 24.00 ± 2.53 | 11 | 28.27 ± 7.17 | ||
| Change from baseline | 6 | -9.50 ± 5.72 | 11 | -1.00 ± 9.22 | 0.0511 | |
| p-value | 0.0096 | 0.7265 | ||||
| ALT (GPT, IU/L) | Baseline (visit 1) | 6 | 40.50 ± 6.47 | 11 | 38.09 ± 6.70 | |
| 6 weeks (visit 3) | 6 | 34.33 ± 12.60 | 11 | 41.00 ± 19.03 | ||
| Change from baseline | 6 | -6.17 ± 13.03 | 11 | 2.91 ± 20.95 | 0.4982 | |
| p-value | 0.2987 | 0.655 | ||||
| 12 weeks (visit 4) | 6 | 25.67 ± 6.47 | 11 | 44.82 ± 17.28 | ||
| Change from baseline | 6 | -14.83 ± 5.04 | 11 | 6.73 ± 15.75 | 0.0088 | |
| p-value | 0.0313 | 0.3564 |