Original ResearchFull Report: Clinical—LiverEfficacy of Obeticholic Acid in Patients With Primary Biliary Cirrhosis and Inadequate Response to Ursodeoxycholic Acid
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Conflicts of interest These authors disclose the following: Gideon M Hirschfield: consultancy for Intercept, BioTie, Lumena, Medigene, Janssen. Andrew Mason: Abbott and Gilead research support; Advisory Board member Novartis. Velimir Luketic: clinical trials Merck, Vertex, BMS, Idenix, Gilead, AbbVie, GSK, Genfit. Keith Lindor: unpaid consultant Intercept Pharmaceuticals and Lumena. Stuart C. Gordon: grant/research support: AbbVie Pharmaceuticals, Bristol-Myers Squibb, Gilead Pharmaceuticals, GlaxoSmithKline, Merck, Roche Pharmaceuticals, Vertex Pharmaceuticals; consultant/Adviser: Bristol-Myers Squibb, CVS Caremark, Gilead Pharmaceuticals, Merck, Vertex Pharmaceuticals; data monitoring board: Tibotec/Janssen. Kris V. Kowdley: grants and research support (paid to institution): AbbVie, Beckman, BMS, Boehinger Ingelheim, Gilead, Ikaria, Intercept Pharmaceuticals, Janssen, Merck, Mochida, Vertex; consultant: Novartis (honorarium paid to institution); service on Advisory Boards: AbbVie, Gilead, Ikaria, Janssen, Merck, Trio Health, Vertex (honorarium paid to institution). Henry C. Bodhenheimer Jr: Intercept: research grant; Lumena: consultant; Vertex: consultant; Novartis: consultant. Michael Trauner: speakers bureau: Falk Foundation; advisor: Falk Pharma, Phenex; travel grants: Falk Foundation; unrestricted research grants: Falk Pharma, Intercept Pharmaceuticals. Luciano Adorini: employed by Intercept Pharmaceuticals. Cathi Sciacca: employed by Intercept Pharmaceuticals. Tessa Beecher-Jones: contracted by Intercept Pharmaceuticals (independent consultant). Erin Castelloe: contracted by Intercept Pharmaceuticals (independent pharmacovigilance consultant). Olaf Böhm: contracted by Intercept Pharmaceuticals; employed by FGK Clinical Research. David Shapiro: employed by Intercept Pharmaceuticals. The remaining authors disclose no conflicts.
Funding Intercept Pharmaceuticals sponsored this clinical trial and supported trial design, data collection, analysis, and trial operation.
Author names in bold designate shared co-first authorship.