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EMA: Concept paper on the need to revise the points to consider on adjustment for baseline covariates

01.03.2012
The Committee for Medicinal Products for Human Use points to consider on adjustment for baseline covariates came into operation in 2003. Since then, they have been widely used by both industry and regulators when planning and assessing confirmatory clinical trials. Changes to the current text are intended to reflect the current state of scientific knowledge in this document which could evolve into a guideline.