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This chapter describes the issues associated with the experimental design and statistical analysis of in vitro and in vivo experiments as well as human studies and other biomonitoring investigations using the Comet assay. The objective is to describe the concepts underlying the designs and analyses rather than provide detailed mathematical descriptions of the various methods. Emphasis is given to the identification of the experimental unit, the role of power and sample size calculations in the design and the care needed to be taken to avoid artefactual results.

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