|  | Final analysis set (N = 486) | |
---|---|---|---|
Visit | Clinical efficacy | Total score | Change from baseline in total score |
Baseline | N (missing) | 486 (0) | Â |
 | Mean (SD) | 16.32 (4.497) |  |
 | Median | 17.00 |  |
 | Min–max | 2.0–24.0 |  |
6Â months | N (missing) | 480 (6) | 480 (6) |
 | Mean (SD) | 16.55 (4.318) | 0.18 (3.741) |
 | Median | 17.00 | 0.00 |
 | Min–max | 6.0–24.0 | −13.0 to 12.0 |
 | P value in comparison to baseline |  | 0.2846 |
12Â months | N (missing) | 483 (3) | 483 (3) |
 | Mean (SD) | 17.34 (4.083) | 1.03 (4.314) |
 | Median | 17.00 | 1.00 |
 | Min–max | 6.0–24.0 | −11.0 to 17.0 |
 | P value in comparison to baseline |  | <.0001 |
18Â months | N (missing) | 447 (39) | 447 (39) |
 | Mean (SD) | 17.47 (4.215) | 0.90 (4.600) |
 | Median | 18.00 | 1.00 |
 | Min–max | 0.0–24.0 | −12.0 to 17.0 |
 | P value in comparison to baseline |  | <.0001 |
24Â months | N (missing) | 436 (50) | 436 (50) |
 | Mean (SD) | 17.85 (4.163) | 1.36 (5.027) |
 | Median | 18.00 | 1.00 |
 | Min–max | 0.0–24.0 | −14.0 to 16.0 |
 | P value in comparison to baseline |  | <.0001 |