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Article History

Received: 29 December 2018

Accepted: 10 June 2019

First Online: 5 July 2019

Ethics approval and consent to participate

: These studies were conducted in accordance with the International Conference on Harmonization guidelines for Good Clinical Practice and the ethical principles of the Declaration of Helsinki. Written informed consent was obtained from all patients prior to enrollment. The institutional review board or independent ethics committee at each participating center reviewed and approved all consent forms and the study protocol.

: Not applicable.

: YT has received speaking fees and/or honoraria from Daiichi-Sankyo, Astellas, Eli Lilly, Chugai, Sanofi, AbbVie, Pfizer, YL Biologics, Bristol-Myers, GlaxoSmithKline, UCB, Mitsubishi-Tanabe, Novartis, Eisai, Takeda, Janssen, and Asahi-kasei and has received research grants from Mitsubishi-Tanabe, Bristol-Myers, Eisai, Chugai, Takeda, AbbVie, Astellas, Daiichi-Sankyo, Ono, MSD, and Taisho-Toyama. JSS has received research grant support from Abbott, BMS, MSD, Pfizer, Roche, and UCB and consultation and/or speaking honoraria from Abbott, Astra-Zeneca, BMS, Celgene, Celltrion, Glaxo, Janssen, MSD, Pfizer, Roche, Samsung, Sanofi-Aventis, and UCB. HJ and LM were employees of Pfizer at the time the manuscript was written. AS is an employee of Syneos Health and was contracted by Pfizer to provide statistical support for the development of this paper. PE has received grant/research support and consultancy fees from AbbVie, BMS, Lilly, MSD, Novartis, Pfizer, Roche, Samsung, Sandoz, and UCB.No nonfinancial competing interest exists for any author.