Designing an exploratory phase 2b platform trial in NASH with correlated, co-primary binary endpoints

• Elias Laurin Meyer,

  Roles Conceptualization, Methodology, Software, Visualization, Writing – original draft, Writing – review & editing

  Affiliation Center for Medical Data Science, Medical University of Vienna, Vienna, Austria

  https://orcid.org/0000-0001-5398-6334

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• Peter Mesenbrink,

  Roles Conceptualization, Methodology, Writing – review & editing

  Affiliation Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, United States of America

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• Nicholas A. Di Prospero,

  Roles Conceptualization, Methodology, Writing – review & editing

  Affiliation Janssen Research and Development, Raritan, NJ, United States of America

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• Juan M. Pericàs,

  Roles Conceptualization, Methodology, Writing – review & editing

  Affiliations Liver Unit, Internal Medicine Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute for Research (VHIR), Barcelona, Spain, Centros de Investigación Biomédica en Red Enfermedades Hepáticas y Digestivas (CIBERehd), ISCIII, Madrid, Spain

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• Ekkehard Glimm,

  Roles Methodology, Writing – review & editing

  Affiliations Novartis Pharma AG, Basel, Switzerland, Institute of Biometry and Medical Informatics, University of Magdeburg, Magdeburg, Germany

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• Vlad Ratziu,

  Roles Writing – review & editing

  Affiliation Assistance Publique-Hôpitaux de Paris, Hôpital Pitie-Salpetriere, University of Paris, Paris, France

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• Elena Sena,

  Roles Project administration, Writing – review & editing

  Affiliation Liver Unit, Internal Medicine Department, Vall d’Hebron University Hospital, Vall d’Hebron Institute for Research (VHIR), Barcelona, Spain

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• Franz König ,

  Roles Conceptualization, Methodology, Supervision, Validation, Writing – original draft, Writing – review & editing

  * E-mail: franz.koenig@meduniwien.ac.at

  Affiliation Center for Medical Data Science, Medical University of Vienna, Vienna, Austria

  https://orcid.org/0000-0002-6893-3304

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• on behalf of the EU-PEARL NASH Investigators

  ¶Membership of The EU-PEARL NASH Investigators is provided in the Acknowledgments.

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