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EMA: Draft guideline on adjustment for baseline covariate

04.07.2013
The note for guidance on statistical principles for clinical trials (ICH E9) briefly addresses the problem of adjustment for covariates. It advises experimenters ‘to identify the covariates expected to have an important influence on the primary outcome’ and to specify ‘how to account for them in the analysis in order to improve precision and to compensate for any lack of balance between groups’.