Intervention group Mean (SD) n() | Control group Mean (SD) n () | Unadjusted Difference in means 95% CI | |
---|---|---|---|
Primary outcome | |||
Score at 1 month Per protocol analysis n = 100 | 53.9 (13.8) n = 45 | 42.5 (9,1) n = 55 | 11.3 6.8 to 15.9 |
Score at 1 month Intention-to-treat analysis n = 104 | 53.7 (9.73) n = 104 | 42.70 (6.89) n = 98 | 11,0 8,67 to 13,32 |
Secondary outcome | |||
Change from baseline score (T1-T0) Per protocol analysis | 0.5 (17.3) | -11.5 (12.4) | 11.9 5.9 to 17.95 |