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Practical guide to sample size calculations: non-inferiority and equivalence trials
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Abstract
<p class="first" id="d6995091e64">A sample size justification is a vital part of any
trial design. However, estimating
the number of participants required to give a meaningful result is not always straightforward.
A number of components are required to facilitate a suitable sample size calculation.
In this paper, the steps for conducting sample size calculations for non-inferiority
and equivalence trials are summarised. Practical advice and examples are provided
that illustrate how to carry out the calculations by hand and using the app SampSize.
</p>