Brandes 2007 Study 2.

Study characteristics
Methods	Multicentre, R, DB, PC, parallel group. Single dose to treat single attack Medication taken when PI ≥ moderate Assessments at 0, 0.5, 1, 1.5, 2, then hourly to 24 h
Participants	Migraine ± aura (IHS 2004), aged 18 to 65 years. History: > 6 months with frequency of 2 to 6 per month and untreated severity ≥ moderate Excluded: uncontrolled hypertension, cardio‐ or cerebrovascular disease, using MAOI, ergot, SJW, or NSAID N = 1495 F = 88% Mean age 40 years 76% without aura
Interventions	Sumatriptan 85 mg plus naproxen 500 mg, n = 367 (362 for efficacy) Sumatriptan 85 mg, n = 370 (362 for efficacy) Naproxen 500 mg, n = 371 (364 for efficacy) Placebo, n = 387 (382 for efficacy) Rescue medication allowed after 2 h if necessary (as prescribed by physician but not ergot‐containing, serotonin agonist, or NSAID‐containing medications)
Outcomes	Headache relief at 2 h Pain‐free at 2 h 24‐h sustained headache relief 24‐h sustained pain‐free Presence and relief of associated symptoms at 2 h Presence and relief of functional disability at 2 h (from Landy 2007) Use of rescue medication AEs Withdrawals
Notes	Oxford Quality Score: R1, DB1, W1. Total = 3
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Not described
Incomplete outcome data (attrition bias) All outcomes	Low risk	Drop‐outs described
Study size	Low risk	> 200 participants per treatment arm