Comparing two independent incidence rates using conditional and unconditional exact tests.

Several unconditional exact tests, which are constructed to control the Type I error rate at the nominal level, for comparing two independent Poisson rates are proposed and compared to the conditional exact test using a binomial distribution. The unconditional exact test using binomial p-value, likelihood ratio, or efficient score as the test statistic improves the power in general, and are therefore recommended. Unconditional exact tests using Wald statistics, whether on the original or square-root scale, may be substantially less powerful than the conditional exact test, and is not recommended. An example is provided from a cardiovascular trial.