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PageLayout: SinglePage PageMode: UseNone Language: en-US Outlines: Item: Title: Study protocol of a randomised, double-­blind, placebo-­controlled, two-­arm parallel-­group, multi-­centre phase 3 pivotal trial to investigate the efficacy and safety of recombinant human alkaline phosphatase for treatment of patients with seps Children: Item: Title: Abstract Item: Title: Introduction Children: Item: Title: Recombinant human ALP (recAP and ilofotase alfa) Item: Title: Trial objectives Item: Title: Methods and analysis Children: Item: Title: Patients Item: Title: Trial oversight Item: Title: Patient and public involvement statement Item: Title: Trial design Item: Title: Statistical considerations Item: Title: Safety endpoints Item: Title: Population PK Item: Title: Sensitivity analyses and secondary endpoints Item: Title: Ethics and dissemination Item: Title: References Info: Creator: Adobe InDesign 15.1 (Windows) Producer: Adobe PDF Library 15.0 CreationDate: Mon Apr 03 04:39:40 CEST 2023 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