Appropriate statistical methods for analysing trial data are critical for the correct interpretation of the results. Item 12 of the CONSORT statement (Box 1) relates to the statistical methods used in the reporting of trials, together with scientific and statistical principles concerning analyses of subgroups, endpoints and appropriate statistical tests. These issues need to be carefully considered before beginning a study and should be outlined in a standard trial protocol, which may be supplemented by a more extensive statistical analysis plan.1
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