Abstract:BackgroundThe European multicentre paediatric trials for the drug development programme of LENA (FP7 Grant agreement No. 602295); ‘Labeling of Enalapril from Neonates up to Adolescents’ require the determination of laboratory safety parameters. It was anticipated that the laboratory normal reference values and age range classifications vary depending on the clinical site. Thus, the objective was a seamless and clear depiction of the laboratory parameters to allow an adequate subsequent analysis of data.Methods… Show more
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