Characteristics | TSC (N = 750) | Placebo (N = 250) | P values | |
---|---|---|---|---|
Age, mean ± SD, y | 47.59 ± 11.86 | 47.82 ± 12.84 | 0.5957 | |
Height, mean ± SD, cm | 165.81 ± 6.89 | 165.61 ± 7.35 | 0.4332 | |
Weight, mean ± SD, Kg | 63.89 ± 9.32 | 63.57 ± 9.75 | 0.5717 | |
Sex (%) | Male | 277 (36.9%) | 85 (34.0%) | 0.4018 |
Female | 473 (63.1%) | 165 (66.0%) | ||
Ethnic (%) | Han | 745 (99.3%) | 248 (99.2%) | 1.0000 |
Others | 5 (0.7%) | 2 (0.8%) | ||
Marital status (%) | Yes | 714 (95.2%) | 238 (95.2%) | 1.0000 |
No | 36 (4.8%) | 12 (4.8%) | ||
Profession (%) | Physical | 149 (19.9%) | 52 (20.8%) | 0.7505 |
Non-physical | 601 (80.1%) | 198 (79.2%) | ||
Women of child-bearing age (%) | Yes | 221 (46.7%) | 81 (49.1%) | 0.5999 |
No | 252 (53.3%) | 84 (50.9%) | ||
Menstrual cycle, mean ± SD, d | 28.60 ± 2.47 | 28.56 ± 2.23 | 0.5932 | |
Menstrual period, mean ± SD, d | 5.25 ± 1.37 | 5.70 ± 1.48 | 0.0114 | |
Diagnosis, no. (%) | Migraine with aura | 200 (26.7%) | 58 (23.2%) | 0.2742 |
Migraine without aura | 550 (73.3%) | 192 (76.8%) | ||
Headache attacks during the 3 months before screening period, mean ± SD, no. | 8.81 ± 2.22 | 8.76 ± 2.33 | 0.7412 | |
Allergic history, no. (%) | Yes | 22 (2.9%) | 3 (1.2%) | 0.1012 |
No | 728 (97.1%) | 247 (98.8%) | ||
Past medical history, no. (%) | Yes | 57 (7.6%) | 22 (8.8%) | 0.5468 |
No | 693 (92.4%) | 228 (91.2%) | ||
Use of headache treatment drugs, no. (%) | Yes | 310 (41.3%) | 103 (41.2%) | 0.9704 |
No | 440 (58.7%) | 147 (58.8%) | ||
With other diseases, no. (%) | Yes | 54 (7.2%) | 25 (10.0%) | 0.1652 |
No | 696 (92.8%) | 225 (90.0%) |