Fig. 1

Primary and secondary outcome measures in the full analysis set (FAS). a: Percentage of patients with ≥50% reduction in frequency of headache; b: Frequency of headache; c: Severity of headache; d: Usage of acute analgesics; e: Percentage of patients with ≥50% reduction in severity of headache. The percentage of patients with ≥50% reduction in frequency of headache (a) increased gradually in the TSC group and was significantly different from the placebo group at week 8 (***P < 0.001). The frequency of headache (b) in the TSC group was significantly lower than in the placebo group after 8 weeks of treatment (***P < 0.001). The severity of headache (c) and usage of acute analgesics (d) were significantly lower in the TSC group than those in the placebo group after 4 weeks of treatment (***P < 0.001). The percentage of patients with ≥50% reduction in headache severity (e) was significantly increased in the TSC group compared with the placebo group after 8 weeks of treatment (***P < 0.001)