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Article History

Accepted: 24 March 2023

First Online: 6 May 2023

Declarations

:

: This trial was supported by Taiho Pharmaceutical Co., Ltd. and Merck Biopharma Co., Ltd., Tokyo, Japan, an affiliate of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945).

: Author <i>NI</i> has received scholarship endowments from Taiho Pharmaceutical. Author <i>NB</i> has received lecture fees or honoraria from Bristol-Myers Squibb, Daiichi-Sankyo, Ono Pharmaceutical, and Taiho Pharmaceutical, and research funds from Ono Pharmaceutical and Takeda. Author <i>KN</i> has received lecture fees or honoraria from AstraZeneca, Boehringer-Ingelheim, Chugai Pharmaceutical, Eli Lilly Japan, Novartis, and Pfizer, and research funds from Boehringer-Ingelheim and Eli Lilly Japan. Author <i>HK</i> has received lecture fees or honoraria from Taiho Pharmaceutical and Merck Biopharma, and research funds from Taiho Pharmaceutical. Author <i>TE</i> has received lecture fees or honoraria from Taiho Pharmaceutical. Author <i>YS</i> has received lecture fees or honoraria from Taiho Pharmaceutical and Merck Biopharma, and scholarship endowments from Taiho Pharmaceutical. Author <i>TEN</i> has received lecture fees or honoraria from Taiho Pharmaceutical and research funds from Taiho Pharmaceutical. Author <i>KM</i> has received lecture fees or honoraria from Taiho Pharmaceutical and research funds from Taiho Pharmaceutical and Merck biopharma. The other authors have declared no conflicts of interest.

: The study was approved by the certified review board and conducted according to the Declaration of Helsinki and <i>Clinical Trial Act</i>. Written informed consent was obtained from all patients before study enrollment. This study was registered in the Japan Registry of Clinical Trials (jRCTs041180156).

: All patients provided written, informed consent.

: All patients provided written, informed consent.

: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

: Not applicable.

: Study concept: NI, KK, CK, TEN, and KM. Study design: NI, KK, CK, MS, TEN, and KM. Acquisition, analysis, or interpretation of data: All authors. Statistical analysis: NI and MS. Manuscript preparation: NI, YS, and TEN. Manuscript editing and revision: All authors. Manuscript review and approval: All authors.