| Baseline | p | 3 Months | p | 6 Months | p | 9 Months | p | 12 Months | p | Δ0-6 |  | Δ6-12 |  | Δ0-12 |  |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
 | Mean ± SEM |  | Mean ± SEM |  | Mean ± SEM |  | Mean ± SEM |  | Mean ± SEM |  | Mean ± SEM | p | Mean ± SEM | p | Mean ± SEM | p |
VAS 1 | ||||||||||||||||
 Test | 8.8 ± 0.49 |  | 9.3 ± 0.15 |  | 9.3 ± 0.16 |  | 9.3 ± 0.13 |  | 9.6 ± 0.11 |  | 0.52 ± 0.52 | 0.906 | 0.23 ± 0.13 | 0.568 | -0.75 ± 0.50 | 0.695 |
 Control | 9.4 ± 0.15 |  | 9.5 ± 0.10 |  | 9.5 ± 0.16 |  | 9.6 ± 0.10 |  | 9.5 ± 0.14 |  | 0.10 ± 0.11 | 0.933 | 0.25 ± 0.17 | 0.999 | 0.12 ± 0.16 | 0.963 |
 Difference | -0.6 ± 0.51 | 0.260 | -0.2 ± 0.18 | 0.405 | -0.2 ± 0.23 | 0.509 | -0.3 ± 0.17 | 0.113 | 0.1 ± 0.18 | 0.767 | 0.43 ± 0.53 | 0.423 | 0.20 ± 0.22 | 0.345 | 0.63 ± 0.52 | 0.233 |
VAS 2 | ||||||||||||||||
 Test | 7.4 ± 0.56 |  | 8.1 ± 0.41 |  | 8.1 ± 0.33 |  | 8.0 ± 0.33 |  | 8.8 ± 0.25 |  | -0.61 ± 0.52 | 0.843 | 0.79 ± 0.31 | 0.208 | 1.39 ± 0.53 | 0.181 |
 Control | 9.1 ± 0.20 |  | 9.1 ± 0.20 |  | 9.0 ± 0.24 |  | 9.1 ± 0.20 |  | 8.7 ± 0.21 |  | 0.07 ± 0.20 | 0.998 | -0.33 ± 0.26 | 0.812 | -0.39 ± 0.28 | 0.758 |
 Difference | -1.7 ± 0.59 | 0.006 | -1.0 ± 0.46 | 0.040 | -1.0 ± 0.41 | 0.018 | -1.0 ± 0.36 | 0.009 | 0.09 ± 0.33 | 0.785 | 0.67 ± 0.55 | 0.225 | 1.10 ± 0.40 | 0.008 | 1.78 ± 0.60 | 0.005 |