Include as part of your calculation adequate power calculations and a hypothesized effect size, ideally based on relevant literature. Research plans should demonstrate a power level that is sufficient to detect differences between comparators for outcomes. For cluster randomized control trials, describe whether the power calculations are based on the number of individuals recruited or the number of clusters used, and include the rationale for choosing one over the other. You should also document the number of individuals per cluster, along with other statistically relevant information, such as the expected interclass correlation between clusters.
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