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. 2012 Feb 15;2012(2):CD009665. doi: 10.1002/14651858.CD009665

Bates 1994.

Methods Multicentre, randomised, double‐blind, placebo‐controlled, parallel‐group. Single dose to treat single attack.
Medication administered at onset of migraine aura
Assessments at 0.5, 1, 1.5, 2, 4, 6, 12, and 24 h after dosing
Second unblinded dose of sumatriptan 6 mg available after 2 h for inadequate relief
Rescue medication available 2 h after second dose of study medication
Participants Aged 18 to 65 years, meeting IHS criteria for migraine (1988) with aura. At least 6‐month history of migraine (untreated severity ≥ moderate) and at least 50% of attacks with aura.
Excluded participants with previous use of subcutaneous sumatriptan
N = 177 (171 for efficacy, 82 with moderate or severe baseline pain intensity)
M 46, F 125 (73%)
Mean age 40 years
All treated attacks with aura
Interventions Sumatriptan 6 mg, n = 90 (88 for efficacy, 47 with moderate or severe baseline pain intensity)
Placebo, n = 87 (83 for efficacy, 35 with moderate or severe baseline pain intensity)
Outcomes Headache relief (at 1 h)
Adverse events
Withdrawals
Notes Oxford Quality Score: R1, DB2, W1. Total = 4.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding (performance bias and detection bias) 
 All outcomes Low risk Matching placebo
Study size High risk Treatment groups < 50 participants