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Article History

Received: 10 October 2024

Accepted: 2 January 2025

First Online: 13 January 2025

Declarations

: Ethical approvalThe study follows the principles of the Declaration of Helsinki for all human experimental investigations. The study is expected be approved by the appropriate institutional review board or ethnic committee of the participating clinical centers or hospitals. Informed consent will be obtained from all participating patients.

: The trial is registered at clinicaltrials.gov. The registration identifier is NCT06290765.

: A Yacoub: consultancy: Incyte, CTI Pharma (SOBI), PharmaEssentia, Pfizer, Novartis, Servier, ABBVIE, Karyopharm Therapeutics, GSK, Blueprint Medicine, Apellis, Gilead, Notable Labs, and Protagonist; Research funding: CTI Pharma (SOBI), Stemline Therapeutics.G Abu-Zeinah: no competing interests to declare;A Qin: working for PharmaEssentia and serving as the company’s chief medical officer;T Tashi: Blueprint (Consultancy, research funding and speakers bureau), PharmaEssentia (Consultancy, research funding and speakers bureau), Cogent (Consultancy, research funding), CITI Biopharma (Consultancy, research funding and speakers bureau), Italfarmaco (Consultancy), and Telios. Research funding (Consultancy).W Da’na: no competing interests to declare;W Shih: serving as a consultant of PharmaEssentia;O Zagrijtschuk: working for PharmaEssentia USA;C Tsai: working for PharmaEssentia Corporation;N Komatsu: Served as a board member of and received funding for medical writing and article processing charges from PharmaEssentia Japan K.K. and received research funding from Meiji Seika Pharma Co., Ltd. and consulting fees from Torii Pharmaceutical Co., Ltd.;R Mesa: Consultant (Honoraria) over past 3 years: Abbvie, Blueprint, BMS, CTI, Genentech, Geron, GSK, Incyte, Novartis, Sierra, Sierra Oncology, Telios; Research Support: Abbvie, Blueprint, BMS, CTI, Genentech, Incyte, Morphosys, Sierra;H Gill: Consulting fees/Speaker fees from Abbvie, Bristol Myers Squibb, GSK, MSD, Novartis, PharmaEssentia Corporation and Pfizer, Advisory board for Abbvie, Bristol Myers Squibb, GSK, Novartis, PharmaEssentia Corporation and Pfizer, Research support from Celgene, MSD, Novartis and PharmaEssentia Corporation, Conference support from Bristol Myers Squibb, MSD, Novartis, Otsuka, PharmaEssentia and Pfizer.