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Article History

Received: 10 July 2023

Accepted: 15 September 2023

First Online: 28 September 2023

Change Date: 5 October 2023

Change Type: Update

Change Details: Capitalization in title and correct version of ESM files have been updated

Declarations

:

: AP-G: Personal fees and non-financial support: AstraZeneca, Novartis, GSK, Sanofi-Genzyme and Teva; ALN: Personal fees: AstraZeneca; non-financial support: Sanofi-Genzyme; IMC: Personal fees: AstraZeneca and Novartis; non-financial support: AstraZeneca; PA: Personal fees and non-financial support: AstraZeneca, Sanofi-Genzyme and GSK; LCF: Personal fees: AstraZeneca, Novartis, GSK and Teva; non-financial support: Sanofi-Genzyme; IG-M: Personal fees and non-financial support: AstraZeneca, GSK, Teva, Novartis, Sanofi-Genzyme; JLV-G: Personal fees: AstraZeneca, Sanofi-Genyme and GSK; non-financial support: AstraZeneca; RA-E: Personal fees and non-financial support: AstraZeneca, GSK, Teva, Novartis and Sanofi-Genzyme; FC-M: Personal fees and non-financial support: AstraZeneca, GSK, Novartis, Sanofi-Genzyme and Teva; EM-M: Personal fees: AstraZeneca, GSK and Sanofi-Genzyme; non-financial support: AstraZeneca; CMR: Personal fees: AstraZeneca, Novartis, GSK, Teva and Sanofi-Genzyme; non-financial support: AstraZeneca, GSK and Teva; EVS: Personal fees: AstraZeneca, GSK, Novartis and Sanofi-Genzyme; non-financial support: Sanofi-Genzyme and GSK; FS-TL: Personal fees: AstraZeneca, GSK, Novartis, Teva and Sanofi-Genzyme; non-financial support: AstraZeneca, GSK, Novartis and Sanofi-Genzyme; ATA: Personal fees and non-financial support: AstraZeneca, GSK, Sanofi-Genzyme and Novartis; MBA: Personal fees and non-financial fees from AstraZeneca, Teva, Sanofi-Genzyme and GSK; MV-M: Personal fees and non-financial support: AstraZeneca and GSK; BVA: Personal fees: AstraZeneca, Novartis, GSK and Sanofi-Genzyme; non-financial support: Teva; MPC: Personal fees and non-financial support: AstraZeneca, GSK, Teva, Novartis and Sanofi-Genzyme; JN, JST, GR and EL: employees of AstraZeneca.

: The study was performed in accordance with ethical principles that have their origin in the Declaration of Helsinki and are consistent with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Good Clinical Practice (ICH/GCP) and applicable regulatory requirements. Written informed consent was obtained from all included patients. Ethics committee approval was obtained on 20 September 2020. Patient medical information obtained for this study was confidential and could only be disclosed to the researchers and third parties involved as provided in the informed consent form signed by the patients. Data from all participating sites were combined into a single anonymized dataset for analysis. AstraZeneca maintains confidentiality standards through the assignment of a unique subject identification number for each patient enrolled in this study.

: Not applicable.