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Article History

Received: 24 February 2021

Accepted: 23 July 2021

First Online: 24 August 2021

Declarations

:

: The RAJ3 and RAJ4 studies were conducted in accordance with Good Clinical Practice, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, and local laws and regulations. The protocol and amendments were approved by an Institutional Review Board at each study site, and safety data were reviewed by the independent Data and Safety Monitoring Board. Each patient provided written informed consent prior to treatment initiation.

: Not applicable

: YT reports speaking fees and/or honoraria from Daiichi-Sankyo, Eli Lilly, Novartis, YL Biologics, Bristol-Myers, Eisai, Chugai, AbbVie, Astellas, Pfizer, Sanofi, Asahi-Kasei, GlaxoSmithKline, Mitsubishi-Tanabe, Gilead, and Janssen and has received research grants from Mitsubishi-Tanabe, Chugai, AbbVie, Takeda, UCB, and Daiichi-Sankyo. TT has received grants and speaking fees and/or honoraria from Astellas, Chugai, Daiichi Sankyo, AbbVie, Mitsubishi Tanabe Pharma, Pfizer, Eisai, AYUMI, Nipponkayaku, and Novartis; has received speaking fees and/or honoraria from Gilead, GlaxoSmithKline, Sanofi, Taiho, Taisho, Eli Lilly, Boehringer Ingelheim, Bristol Myers, Janssen, and UCB; and has received grants from Takeda, Asahi-Kasei, and Shionogi. HI, YK, DK, MF, and MR are employees of Astellas Pharma Inc. NMS is an employee of Astellas Pharma Global Development, Inc.