| Methods | D: parallel C: unclear B: double WD: 14/55, additional 19 patients dropped out in post‐randomisation baseline J: 1‐2‐1 DU: 4w/12w/‐ | |
| Participants | N: 74/41 D: 8 migraine with, 61 without, 5 both C: IHS F: 76% A: mean 37 years DU: mean 17 years S: muliple centers in France | |
| Interventions | P: 160 mg (long‐acting) C: Placebo | |
| Outcomes | R: not reported F: 3.15 (sem 0.77) vs. 6.4 (1.70) AU: not reported HI: not reported AEs: similar in both groups Dropouts‐AEs: 0/40 vs. 1/34 V: + | |
| Notes | Uncommon design with randomisation before baseline High dropout rate Intent‐to‐treat analysis unclear No placebo effect | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
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