Winner 2002.

Study characteristics
Methods	Randomized, double‐blind, placebo‐controlled, parallel‐group trial of oral rizatriptan
Participants	Participants were 12‐17 yrs, with an average of at least 1 but no more than 8 migraines per IHS 1988 criteria and stratified in 2 groups: 12‐14 years and 15‐17 years. Efforts were made to enrol equal numbers in each age group. Randomized (N = 360); did not receive study medication (N = 64); primary efficacy analysis (N = 296)
Interventions	Each participant was instructed to take the study medication (rizatriptan 5 mg or placebo) within 30 min of onset of a moderate or severe migraine
Outcomes	Pain‐free at 2 h Headache relief (reduction in pain to mild or none) at 2 h Presence of nausea Use of rescue medication Headache recurrence (within 24 h) Adverse events Other reported outcomes: Presence of photophobia or phonophobia Functional disability
Headache severity scale	4‐level (none, mild, moderate, severe)
Funding source	Merck
Publication	Journal
Notes	—
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were randomly assigned"
Allocation concealment (selection bias)	Unclear risk	Comment: no information provided.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	Comment: no information provided
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: small imbalance of missing outcome data in the placebo group (N = 6 vs N = 1)
Selective reporting (reporting bias)	Low risk	Comment: all expected outcomes reported