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Article History

Received: 30 March 2023

Revised: 13 August 2023

Accepted: 21 August 2023

First Online: 5 September 2023

Declarations

:

: S.I. reports research funding from Ono, MSD, Celgene, AbbVie, Takeda, Sanofi, Bristol-Myers Squibb, Daiichi-Sankyo, Janssen, Novartis, Alexion, GSK, Chugai, Otsuka, and Astellas-Amgen and honoraria from Ono, Celgene, Takeda, Bristol-Myers Squibb, Sanofi, and Janssen outside the submitted work. K.S. reports research funding from Ono, MSD, Celgene, AbbVie, Takeda, Sanofi, Bristol-Myers Squibb, Daiichi-Sankyo, Janssen, Novartis, Alexion, GSK, Chugai, Otsuka, and Astellas-Amgen and honoraria from Ono, Celgene, Takeda, Bristol-Myers Squibb, Sanofi, and Janssen outside the submitted work. Y.M. reports consulting fees from Chugai Roche; research funding from Takeda, Bristol-Myers Squibb, E-sai, Taiho, and Kyowa-Kirin. T.F. reports employment and ownership interest from GSK outside the submitted work. H.K. reports employment from GSK outside the submitted work. T.T. was an employee of GSK at time of study and reported ownership interest from GSK outside the submitted work. Y.M. was an employee of GSK at time of study. M.M. reports employment and ownership interest from GSK outside the submitted work. T.C. reports employment and ownership interest from GSK outside the submitted work. B.E.K. reports employment and ownership interest from GSK outside the submitted work. I.G. was an employee of GSK at time of study.

: The study was done in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines following approval by ethics committees and institutional review boards at each study site. All patients provided written informed consent. This trial is registered at ClinicalTrials.gov (), identification number NCT03828292.