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Article History

Received: 10 December 2021

Accepted: 8 November 2022

First Online: 22 December 2022

Declarations

:

: Each site requires institutional review board (IRB) approval before enrolling. Moreover, written informed consent to participate will be obtained from all participants by the Principal Investigator or delegate.The study will be conducted according to the principles of the World Medical Association’s Declaration of Helsinki and the International Council for Harmonisation guidelines for Good Clinical Practice (GCP). The study will comply with all local, federal, or country-specific regulatory requirements. Informed consent will be signed by each subject (or legally acceptable representative) before any study-related procedures, including washout of medications. If consent is signed more than 30 days before screening, it must be re-signed at screening to affirm the subject’s continued interest to participate in the study.Prior to the study onset, the protocol, informed consent form (ICF), advertisements or materials to be used for subject recruitment, and any other written information to be provided to the subject must be approved by the IRB/independent ethics committee (IEC). Any amendments to the protocol or ICF will require review and approval by the IRB/IEC before the changes are implemented to the study. Documentation of all IRB/IEC submissions/approvals and of the IRB/IEC compliance with ICH Guideline E6 will be maintained by the site.

: Not applicable.

: PWN: Consulting Fee; CSL Behring, ITB-MED. Grant/Research Support; NIH. Honoraria (Speaker); Astellas.GAB: Consulting Fee, Grant/Research Support; Vitaeris Inc./CSL Behring.SC: Consulting Fee; Vitaeris Inc./CSL Behring. Honoraria (Advisory Committee member); Sanofi.RBM: Grant/Research Support; Mallinkcrodt, Transplant Genomics. Honoraria (Steering Committee member); Vitaeris.TvG: Consulting Fee; Aurinia. Grant/Research Support; Chiesi. Honoraria (Advisory Committee member); CSL Behring. Travel; Astellas.JCL: Ownership Interest (stock holder), Salary; CSL Behring.SA: Ownership Interest (stock holder), Salary; CSL Behring.EC: Salary; Vitaeris Inc./CSL Behring.AD: Consulting Fee; CSL Behring, Care Dx. Grant/Research Support; Care Dx.