|
| Visit 2 | Visit 3 | End of study | p value (Overall) |
| Efficacy |
|
|
|
|
| By investigator |
|
|
| 0.008c |
| Very good | 30 (53.6%)3а | 44 (78.6%)2а | 37 (66.1%) |
|
| Good | 17 (30.4%) | 6 (10.7%) | 8 (14.3%) |
|
| Satisfactory | 8 (14.3%) | 6 (10.7%) | 8 (14.3%) |
|
| Without changes | 0 | 0 | 1 (1.8%) |
|
| Aggravation | 1 (1.8%) | 0 | 2 (3.6%) |
|
| By patient |
|
|
| 0.012c |
| Very good | 37 (66.1%) | 48 (85.7%) | 38 (67.9%) |
|
| Good | 15 (26.8%) | 5 (8.9%) | 10 (17.9%) |
|
| Satisfactory | 3 (5.4%) | 3 (5.4%) | 5 (8.9%) |
|
| Without changes | 0 | 0 | 1 (1.8%) |
|
| Aggravation | 1 (1.8%) | 0 | 2 (3.6%) |
|
| Tolerability |
|
|
| 0.368c |
| By investigator |
|
|
|
|
| Very good | 51 (91.1%) | 52 (91.1%) | 50 (89.3%) |
|
| Good | 2 (3.6%) | 3 (5.4%) | 3 (5.4%) |
|
| Satisfactory | 3 (5.4%) | 1 (1.8%) | 1 (1.8%) |
|
| Without changes | 0 | 0 | 0 |
|
| Aggravation | 0 | 0 | 2 (3.6%) |
|
| By patient |
|
|
| 0.368c |
| Very good | 51 (91.1%) | 53 (94.6%) | 51 (91.1%) |
|
| Good | 3 (5.4%) | 2 (3.6%) | 2 (3.6%) |
|
| Satisfactory | 2 (3.6%) | 1 (1.8%) | 1 (1.8%) |
|
| Without changes | 0 | 0 | 0 |
|
| Aggravation | 0 | 0 | 2 (3.6%) |
|