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The aspirin in reducing events in the elderly trial: statistical analysis plan
Aims: To assess whether daily active treatment of 100 mg enteric-coated aspirin will extend the duration of disability-free life in healthy older participants.
Design: A double-blind, randomized, placebo-controlled primary prevention trial undertaken in Australia and the United States with careful adjudication of endpoints including stroke.
Study outcome: In Australia 16,703 individuals were recruited through general practices across five states and territories, and in the United States, 2411 participants were recruited through 34 clinical sites across the country. Follow-up of participants will finish at the end of 2017 with average follow-up exceeding 4.25 years per person.
Discussion: The statistical analysis plan for ASPREE, finalized after closure of recruitment but before the end of patient follow-up, outlines the primary analyses and a range of subgroup and sensitivity analyses.
Publication titleInternational Journal of Stroke
Department/SchoolMenzies Institute for Medical Research
PublisherSage Publications Ltd.
Place of publicationUnited Kingdom
Rights statementCopyright 2017 World Stroke Organization