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In case of mortality within 5 postoperative days, patients were defined as PHLF when bilirubin and prothrombin time were altered according to the forementioned classification
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FDA guidance for RUO and investigational labeling in the IVD context stresses that RUO labeling is tied to laboratory research positioning and should not be used to imply broader product status [17] [18]
Markers 9 , 2124 (1994)
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