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As discussed in chapter 1 the primary object of clinical trials of new drugs is generally to demonstrate efficacy rather than safety. However, a trial in human beings not at the same time adequately addressing safety is unethical, and the assessment of safety variables is an important element of the trial.

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© 2009 Springer Science + Business Media B.V.

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(2009). The Analysis of Safety Data. In: Cleophas, T.J., Zwinderman, A.H., Cleophas, T.F., Cleophas, E.P. (eds) Statistics Applied to Clinical Trials. Springer, Dordrecht. https://doi.org/10.1007/978-1-4020-9523-8_3

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