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. 2020 Aug 19;2020(8):CD009716. doi: 10.1002/14651858.CD009716.pub2

EARLY‐trial.

Study characteristics
Methods Prospective, randomised, open‐label, blinded, endpoint trial in 46 stroke units in Germany
Participants Individuals aged > 18 years presenting with symptoms of an acute ischaemic stroke causing measurable neurological defect (NIHSS 5 to 20). Randomised and treated within 24 hours
Interventions Aspirin 25 mg and extended‐release dipyridamole 200 mg twice daily vs 100 mg aspirin once daily
Outcomes mRS score and vascular adverse events (non‐fatal stroke, TIA, non‐fatal MI, and bleeding complications)
Notes Subset
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised using a pseudorandom number generator
Allocation concealment (selection bias) Low risk Through telephone interview
Blinding of participants and personnel (performance bias)
All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias)
All outcomes Low risk Blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk 20% discontinued treatment due to various causes
Selective reporting (reporting bias) Low risk All expected outcomes reported