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Background Trialists need to plan the data they will collect, how they will do so and how they will analyse it. If data are not collected at the appropriate time, it may be impossible to obtain them later. Inconsistencies in the understanding of participants about the data they are asked to provide may make it impossible to combine it. A lack of advance planning of the analyses may mean that knowledge of the data introduces bias into the reported results.

Smiley faces and the need for careful planning in trials