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. 2022 Jan 14;2022(1):CD000029. doi: 10.1002/14651858.CD000029.pub4

Rödén‐Jüllig 2003.

Study characteristics
Methods Randomisation: randomisation tables, stratified for gender
Concealment: sequentially numbered containers from pharmacy
Double blind
Exclusions during trials: none
Losses to follow‐up: none
Participants Sweden
441 participants
226 (51%) male
100% CT before entry
Ischaemic stroke < 72 hours since stroke onset
SSSS ≥ 1 point
Interventions Treatment: aspirin 325 mg orally once daily
Control: placebo
Duration: 5 days
Outcomes
  • Death

  • ≥ 2 points (may be in different items) worsening on SSSS at 5 days

  • Ability to walk unaided

  • Increased need for ADL help at 3 months

Funding source The trial was supported by grants from the Serafimer Hospital Foundation, the County Council of Stockholm, Department of Research, Development & Education, the Claes Groschinsky Foundation, the Loo and Hans Osterman Foundation, the Eirs 50‐year Foundation, the SALUS 50‐year Foundation, the 1987 Foundation for Stroke Research, the Tore Nilsson Foundation for Medical Research and the Karolinska Institutet Foundations for Research.
Miles Inc through Bayer AG provided the placebo tablets free of charge.
The aspirin tablets were purchased from Miles Inc. These companies were not involved in the conduct of this trial in any other way.
Notes Exclusions: specified in protocol – severe concomitant medical conditions or pre‐existing neurological illness, bleeding risk, blood pressure > 240/140 mmHg
Follow‐up: 3 months
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Standard randomisation tables used.
Allocation concealment (selection bias) Low risk Packages taken in numerical order.
Blinding of participants and personnel (performance bias)
all outcomes Low risk Participants and personnel blinded.
Blinding of outcome assessment (detection bias)
all outcomes Low risk No concerns regarding blinding of outcome assessment.
Incomplete outcome data (attrition bias)
all outcomes Low risk No missing outcome data.
Selective reporting (reporting bias) Low risk Study protocol noted.
Other bias Low risk No sources of other bias identified.