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

PRoFESS.

Study characteristics
Methods Randomised. Allocation concealment
Participants 1360 participants (884 men and 476 women) with a history of stroke. Age of participants was greater than 55 years. Participants had to be hospitalised with stable stroke. 5 of 672 participants in the combination group (aspirin + extended‐release dipyridamole) and 7 of 688 participants in the clopidogrel‐only group were lost to follow‐up. 36 participants complained of headache in the combination group, whilst 3 participants in the clopidogrel‐only group reported adverse effects.
Interventions Aspirin 25 mg twice daily plus extended‐release dipyridamole 200 mg twice daily vs clopidogrel 75 mg alone once daily followed for 90 days
Outcomes Primary outcome: mRS at 30 days
Secondary outcome: recurrent stroke, haemorrhagic transformation
Notes Subset of participants enrolled early
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Methods described.
Allocation concealment (selection bias) Low risk Methods described.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blind
Incomplete outcome data (attrition bias)
All outcomes Low risk 12 of 1360 participants (0.8%) lost to follow‐up
Selective reporting (reporting bias) Low risk All pre‐specified outcomes reported