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This commentary reviews the work of John Graunt and Kenneth J. Rothman on statistical significance and the need for prespecification of study end points. The authors argue that it is dangerous to substitute oversimplifications based exclusively on whether a result has reached statistical significance for a rational process of causal inference. An example is given based on the Celecoxib Lonngterm Arthritis Safety Study.
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Felix M. Arellano. Drug Safety Surveillance, Pfizer Inc, Peapack, New Jersey, USA
Jordi Castellsague. Global Epidemiology, Pfizer, Barcelona, Spain
Copyright Elsevier Limited Nov 2003