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Article History

Received: 18 October 2019

Accepted: 5 March 2020

First Online: 26 March 2020

Ethics approval and consent to participate

: Prior to initiation at each study center, the study protocol was reviewed by an Institutional Review Board (IRB) or Institutional Ethics Committee (IEC).This study was conducted in accordance with International Conference on Harmonisation (ICH) regulations and guidelines regarding Good Clinical Practice (GCP), clinical safety data management, and scientific integrity; with United States (US) Food and Drug Administration (FDA) regulations set forth in 21 Code of Federal Regulations Parts 50, 56, and 312; and with European Union (EU) Community Directives 2001/20, 2001/83, 2003/94, and 2005/28 as enacted into local law. In addition, this study adhered to all local regulatory requirements and requirements for data protection.All subjects provided written informed consent prior to entering the study and before initiation of any study-related procedure.

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: Dr. Genovese reports personal fees from Amgen, outside the submitted work.Juan Sanchez-Burson reports consulting and meetings invitations from Pfizer, Eli Lilly, Sandoz, Sanofi, and Janssen.Dr. Eva Balazs is a Consultant for Amgen and Celltrion, Inc.Dr. Neal, Dr. Wojciechowski, and Dr. Hala have no conflict of interest to disclose.Andrea Everding has consulting contracts with Eli Lilly, Novartis, and Abbvie.Dr. Fanjiang and Dr. Oh are employees of Amgen.Dr. Cohen reports grants and personal fees from Amgen, grants and personal fees from Boehringer Ingleheim, and grants and personal fees from Pfizer, outside the submitted work.