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The occurrence of these complications has been associated with an increased risk of death or dependency.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Aims and design<\/jats:title>\n<jats:p>PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke (PRECIOUS) is an international, multi-centre, 3\u2009\u00d7\u20092 factorial, randomised, controlled, open-label clinical trial with blinded outcome assessment, which will assess whether prevention of aspiration, infections, or fever with metoclopramide, ceftriaxone, paracetamol, respectively, or any combination of these in the first 4\u00a0days after stroke onset improves functional outcome at 90\u2009days in elderly patients with acute stroke.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Discussion<\/jats:title>\n<jats:p>This statistical analysis plan provides a technical description of the statistical methodology and unpopulated tables and figures. The paper is written prior to data lock and unblinding of treatment allocation.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ISRCTN registry <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.isrctn.com\/ISRCTN82217627\">ISRCTN82217627<\/jats:ext-link>. Registered on 22 September 2015. The trial was prospectively registered.<\/jats:p>\n<\/jats:sec>","DOI":"10.1186\/s13063-020-04717-0","type":"journal-article","created":{"date-parts":[[2020,10,26]],"date-time":"2020-10-26T08:03:05Z","timestamp":1603699385000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke\u2014statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0025-8760","authenticated-orcid":false,"given":"Jeroen C.","family":"de Jonge","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa J.","family":"Woodhouse","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hendrik","family":"Reinink","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H. 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