| 
      
        | VAS pain scale (mm) |  
        |  | Screening | Baseline | 3    months | 6    months |  
        | Active | 44.8 ± 12.1 | 46.1 ± 22.4 | 47.4 ± 21.4 | 41.9 ± 29.5 |  
        | Control | 45.4 ± 16.1 | 49.7 ± 20.3 | 49.6 ± 24.8 | 42.6 ± 26.4 |  
        | PGA (Likert) |  
        |  | Screening | Baseline | 3    months | 6    months |  
        | Active | 4.3 ± 1.6 | 4.6 ± 1.8 | 4.7 ± 2.0 | 3.0 ± 2.4 |  
        | Control | 4.9 ± 1.7 | 5.1± 1.6 | 5.0 ± 1.6 | 4.4 ± 2.0 |  |