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. 2010 Jul 7;2010(7):CD002839. doi: 10.1002/14651858.CD002839.pub2

PRISTINE.

Methods Multicentre, double‐blind, placebo‐controlled 
 Randomisation by minimisation 
 Stratified by age and stroke severity 
 ITT and PP analysis
Participants UK, Netherlands, Sweden: 9 centres 
 620 patients: T: 313, C: 307 
 Age: T: 72 years, C: 72 years 
 Male: T: 161, C: 160 
 Inclusion: ACHI 
 100% CT 
 Enrolment within 48 hours
Interventions T: naftidrofuryl fumarate 633 mg/day iv continuous for 7 days then orally for 6 months 
 C: solvent and identical looking tablets 
 Rx: 6 months
Outcomes Death 
 Assessments were at entry and intervals to 1 year 
 Method used for BP measurement not given
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Unclear risk Randomisation by minimisation
Allocation concealment? Unclear risk Unclear from the publication
Blinding? Unclear risk Probably done
Completeness of follow‐up Unclear risk Unclear from the publication