We derive several formulae for the sample size required for a study designed using the self-controlled case series method without age effects. We investigate these formulae by simulation, and identify one based on the signed root likelihood ratio statistic which performs well. We extend this method to allow for age effects, which can have a big impact on the sample size needed. This more general sample size formula is also found to perform well in a broad range of situations. Copyright © 2005 John Wiley & Sons, Ltd.
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