High Quality Content by WIKIPEDIA articles! In the statistical analysis of clinical trials, the rule of three states that if no major adverse events occurred in a group of n people, there can be 95% confidence that the chance of major adverse events is less than one in n / 3 (or equivalently, less than 3 in n). This is an approximate result, but is a very good approximation when n 30. For example, in a trial of a drug for pain relief in 1500 people, none have a major adverse event. The rule of three says we should have 95% confidence that the rate of adverse events is no more frequent than 1 in 500.
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