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Mosaic Clinical Trial Statistical Analysis Plan Primary Analysis V1.2, Gareth Lingham, Emmanuel Kobia-Acquah, James Loughman, Daniel Ian Flitcroft
Mosaic Clinical Trial Statistical Analysis Plan Primary Analysis V1.2, Gareth Lingham, Emmanuel Kobia-Acquah, James Loughman, Daniel Ian Flitcroft
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The Myopia Outcome Study of Atropine Treatment in Children (MOSAIC) is an investigator-led, double-masked randomised controlled trial of nightly atropine 0.01% eye drops compared to nightly placebo eye drops. A previously published protocol paper outlines the rationale, objective and sample size calculation for the study.1 A total of 250 participants were enrolled in the study and were randomised 2:1 to active treatment and placebo, respectively. This document outlines the plan for analysis of the 24-month outcomes of the MOSAIC.