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Selection bias resulting from recruiting participants after cluster allocation has been revealed will be avoided by completing recruitment and screening assessment prior to randomisation.
Data analyses will follow after completing recruitment.
We anticipate completing recruitment by the end of 2016 and final assessments (including follow-up 12 months after study completion) by the end of 2017.
Studies completing recruitment before 1980 were excluded in case of time trends in the incidence of GCA and because the quality of the reporting was generally lower for the older studies.
A sample size of 1,000 patients was used in order to obtain a balance between feasibility of completing recruitment within a reasonable timeline and obtaining a sample size that will support plausible hypotheses of treatment effect and baseline event rates.
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The study completed recruitment in 2008 and all recruits have consented to the use of their data in research.
The Regional Co-ordinators of each country will recruit sufficient hospitals to complete recruitment within the trial's timescale.
Sixty-two centres would need to recruit 0.5 subjects per week to complete recruitment in four years.
This trial began recruiting patients in June 2012 and shall complete recruitment in December 2012.
The earliest cohort study recruited patients starting in 1978 and latest completed recruitment in 2007, with mean reported follow-up ranging from 6 to 18.8 years.
Ninety-five patients completed recruitment and are included in analysis.
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