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Article History

Received: 21 October 2020

Accepted: 26 February 2021

First Online: 16 March 2021

Declarations

:

: This study was conducted in accordance with Good Clinical Practice, the International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines, and local laws and regulations. The protocol and amendments were approved by an institutional review board (IRB) at each study site, and blinded safety data were reviewed by a safety review team. Each patient provided written informed consent prior to treatment initiation.

: Not applicable.

: KW, SB, EQ, SW, and PPT are former employees of and stockholders in GlaxoSmithKline (GSK).KT is an employee of GSK.PCT reports personal consultant fees from GSK and grants from Celgene, Galapagos, and Eli Lilly. He also reports personal fees from AbbVie, Galapagos, Gilead, GSK, Eli Lilly, and Pfizer.CP received nonfinancial support from GSK. He is an employee of and stockholder in Spire Sciences Inc. which received research funding from GSK to conduct the study. He reports consulting or personal fees from AbbVie, Acerta Therapeutics, Five Prime, Genentech, Modern Bioscience, Myriad, Novartis, Roche, Set Point, and Vorso and speakers fees from Amgen and Bristol Myers Squibb.HS, DT, and SWB are employees of and hold stock options in GSK.JW reports personal fees and nonfinancial support from AbbVie, Medac, and Pfizer, and personal fees from Fraunhofer Institute, Gilead, GSK, Janssen-Cilag, Medac, Novartis, and Pfizer.