Silberstein 2008 Study 1.

Study characteristics
Methods	Multicentre, R, DB, PC, parallel group. Single dose to treat single attack Medication taken when PI mild and within 1 h of onset Assessments at 0, 0.5, 1, 2, 4, 24 h
Participants	Migraine ± aura (IHS 2004), aged 18 to 65 years. History: ≥ 6 months with frequency of 2 to 6 attacks per month, and ≤ 15 per month. Untreated severity ≥ moderate, with identifiable mild pain phase Excluded: uncontrolled hypertension, cardio‐ or cerebrovascular disease, gastrointestinal history N = 580 (576 for efficacy) F = 87.5% Mean age 40 years Aura: 20%
Interventions	Sumatriptan 85 mg plus naproxen 500 mg, n = 283 Placebo, n = 297 Rescue medication allowed after 2 h if necessary (not triptans, NSAID‐containing, ergot‐containing or ergot‐like medication)
Outcomes	Pain‐free at 2 h 24‐h sustained pain‐free Presence and relief of associated symptoms at 2 h Presence and relief of functional disability at 2 h (from Taylor 2007) Use of rescue medication AEs Withdrawals
Notes	Oxford Quality Score: R2, DB2, W1. Total = 5
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Computer‐generated randomization schedule"
Allocation concealment (selection bias)	Unclear risk	Not described
Blinding (performance bias and detection bias) All outcomes	Low risk	"Matching placebo"
Incomplete outcome data (attrition bias) All outcomes	Low risk	Drop‐outs described
Study size	Low risk	> 200 participants per treatment arm