Table 1 Baseline characteristics of patients.
Tenoten group 1 | Tenoten group 3 | Placebo | Total | |
|---|---|---|---|---|
ITT-set | n = 126 | n = 130 | n = 128 | n = 384 |
Age, years | ||||
Mean ± SD | 32.7 ± 7.1 | 32.9 ± 7.6 | 34.3 ± 7.7 | 33.3 ± 7.5 |
Sex, n (%) | ||||
Men | 27 (21.4) | 28 (21.5) | 29 (22.7) | 84 (21.9) |
Women | 99 (78.6) | 102 (78.5) | 99 (77.3) | 300 (78.1) |
Diagnostic categories | ||||
Patients with F43, n (%) | 27 (21.4) | 19 (14.6) | 31 (24.2)* | 77 (20.0)* |
Patients with F45, n (%) | 56 (44.4) | 67 (51.5) | 62 (48.4) | 185 (48.2) |
Patients with F48, n (%) | 43 (34.1) | 44 (33.8) | 36 (28.1) | 123 (32.0) |
HAM-A, score | ||||
Mean ± SD | 18.81 ± 5.81 | 18.38 ± 4.3 | 17.88 ± 5.42 | |
EQ-5D-3L, score | ||||
Mean ± SD | 7.44 ± 1.44 | 7.42 ± 1.05 | 7.48 ± 1.28 | |
PP-set | n = 114 | n = 119 | n = 111 | n = 344 |
Age, years | ||||
Mean ± SD | 32.6 ± 7.0 | 33.0 ± 7.5 | 34.5 ± 7.5 | 33.3 ± 7.4 |
Sex, n (%) | ||||
Men | 26 (22.8) | 26 (21.8) | 24 (21.6) | 76 (22.1) |
Women | 88 (77.2) | 93 (78.2) | 87 (78.4) | 268 (77.9) |
Diagnostic categories | ||||
Patients with F43, n (%) | 25 (21.9) | 18 (15.1) | 28 (25.2) | 71 (20.6) |
Patients with F45,n (%) | 48 (42.1) | 62 (52.1) | 55 (49.5) | 165 (47.9) |
Patients with F48,n (%) | 41 (35.9) | 39 (32.8) | 28 (25.2) | 108 (31.4) |
HAM-A, score | ||||
Mean ± SD | 18.49 ± 5.44 | 18.50 ± 4.38 | 18.05 ± 5.01 | |
EQ-5D-3L, score | ||||
Mean ± SD | 7.41 ± 1.25 | 7.42 ± 1.08 | 7.5 ± 1.26 | |