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FDA Executive Summary Supplement Statistical Issues The sponsor provided more data from the AKH Registry and presented the results from a Bayesian analysis of the data. FDA reviewed this information below are issues iden
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Document Date: 2005-03-16 08:49:42


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IndustryTerm

investigational device / /

MedicalCondition

hypothermia / /

Organization

FDA / /

Position

statistician / Executive / /

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