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Message: 0.05 P-values -- A bridge too far ?

As you correctly say, the important thing is the FDA recognizes it’s imperfect.

They don’t think the way journalists write - that a trial « was negative » or « failed » - just because P=0.06 and not 0.05. This story isn’t over yet. 

One of the most important clinical trials ever in heart disease prevention, the Lipid Research Clinics Coronary Primary Prevention Trial in the pre-statin era, was accepted by the FDA as demonstrating that lowering LDL cholesterol with cholestyramine reduced the incidence of heart attacks, even though the P value was as high as 0.10. History has shown they made the right decision.

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