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3.10.2 Analysis

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As with determining the trial size, the format of the analysis will depend on the type of questions being posed, the trial design, the type of endpoint variables and whether or not characteristics of the patients themselves need to be taken into account. If there is only a single endpoint concerned, then the plan for the subsequent analysis may be described rather succinctly except in circumstances where the analysis may be unusual in format. In some situations, several endpoints will be included so that a careful description of the analytic approach for each needs to be detailed. In these circumstances, multiple statistical tests may be concerned and cognisance of that may need to be taken into account.

Randomised Clinical Trials

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