FASTER 2007.

Methods	Randomized controlled trial with 2 × 2 factorial design. Participants assigned to clopidogrel or placebo, and to placebo or simvastatin.
Participants	392 people with TIA or a minor ischaemic stroke (defined by a NIHSS score ≤ 3), who were randomised to double placebo or to simvastatin plus placebo. Baseline characteristics: clopidogrel only: n = 98, mean age (± SD) 68.9 ± 13.0 years, female 46.9%; simvastatin and clopidogrel: n = 100, mean age (± SD) 67.1 ± 12.9 years, female 39%; double placebo: n = 95, mean age (± SD) 69.8 ± 12.3 years, female 55.8%; simvastatin only: n = 99, mean age (± SD) 66.6 ± 14.2 years, female 47.5%.
Interventions	Aspirin 81 mg daily (with a loading dose of 162 mg if they were naive to aspirin before study enrolment) plus clopidogrel 300 mg loading dose immediately followed by clopidogrel 75 mg daily (n = 198) for 3 months. Placebo (n = 194) for 3 months.
Outcomes	Primary efficacy outcome: stroke (ischaemic or haemorrhagic) within 90 days of randomisation. Stroke severity measured by NIHSS, mRS, and Barthel index scores 90 days after stroke. Secondary outcomes: combination of any stroke, MI and vascular death; combination of any stroke, TIA, acute coronary syndrome or all‐cause death.
Notes	Trial stopped early due to failure to recruit participants at the prespecified minimum enrolment rate.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"A blocked randomization procedure generated by the trial biostatistician was used by the central trial pharmacist to produce identical numbered study treatment kits containing active drug or matched placebo."
Allocation concealment (selection bias)	Low risk	"A blocked randomization procedure generated by the trial biostatistician was used by the central trial pharmacist to produce identical numbered study treatment kits containing active drug or matched placebo ... The central pharmacist, who played no role in the care of the patients, was the only person aware of treatment allocation."
Blinding (performance bias and detection bias) All outcomes	Low risk	"The trial was blinded (patients, treating physicians, nurses and study site coordinators). The central pharmacist, who played no role in the care of the patients, was the only person aware of treatment allocation."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Extensively described. "Seven patients (1.8%) were lost to follow‐up and are assumed not to have had outcome events for the purposes of the analysis."
Selective reporting (reporting bias)	Low risk	Outcomes reported as per protocol.
Other bias	Low risk	Partially pharmaceutical industry funded. "The clopidogrel placebo was provided by Sanofi‐Aventis; both simvastatin and placebo were provided by Merck‐Frosst Canada. Peer review by the Canadian Institutes of Health Research mandated the pilot phase of this trial design to determine feasibility. Other than this aspect of the trial design, none of the trial sponsors played any role in the trial design, data collection, analysis, interpretation, or in the writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit it for publication."