The analysis ofthe data from a randomized trial should be approached with considerable care. In this chapter, we have provided approaches to minimize the bias and address many of the difficulties which arise. We have paid particular attention to practical issues and purposely limited mathematical presentations. It is important that an experienced statistician, preferably with a knowledge of the disease, is involved in the analysis of such data. Nevertheless, it is important that readers as well as practitioners are aware of the possible pitfalls and possible solutions. The advice presented in this chapter together with the advice presented in Chapter 10 on reporting results, should provide all with a basic grounding on the major issues in the analysis of data from a randomized trial.

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