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Article History

Received: 28 October 2025

Accepted: 31 December 2025

First Online: 4 February 2026

Declarations

:

: The study protocol (ClinicalTrials.gov: NCT04991051) and all study documents were reviewed and approved prior to enrolment by the following independent ethics committees/institutional review boards. Written informed consent was obtained from all participants (or next of kin/legal representatives) before any study procedures. The study was conducted in accordance with the Declaration of Helsinki, Good Clinical Practice, and applicable local regulations.• Egypt:◦ Research Ethics Committee for Human Subject Research, National Air Force Specialized Hospital, Cairo, Egypt◦ Institutional Review Board, Faculty of Medicine, Alexandria University, Alexandria, Egypt◦ Institutional Review Board, Faculty of Medicine, Assiut University, Assiut, Egypt◦ Institutional Review Board, National Cancer Institute, Cairo University, Cairo, Egypt◦ Institutional Review Board, Shifaa Al-Orman Hospital, Luxor, Egypt• Iraq: ◦Ministry of Health and Environment – The National Centre for Training and Human Development, Baghdad, Iraq• Jordan:◦ King Hussein Cancer Center Institutional Review Board, Amman, Jordan• Saudi Arabia:◦ Research and Innovation, King Abdullah Medical City in the Holy Capital (KAMC-HC), Makkah, Saudi Arabia◦ Institutional Review Board, International Medical Center, Jeddah, Saudi Arabia• Turkey:◦ Çukurova University Clinical Research Ethics Committee, Adana, Turkey• United Arab Emirates:◦ Scientific Research Ethics Committee, Department of Health – Abu Dhabi, Abu Dhabi, UAE• Kuwait:◦ Scientific Research and Ethics Committee, Ministry of Health, Kuwait• Oman:◦ Scientific Research Committee, Royal Hospital, Muscat, Oman• Qatar:◦ Hamad Medical Corporation Institutional Review Board, Doha, Qatar

: Not applicable.

: Dr. Emad Shash served in advisory or consultancy roles for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Clinart MENA, Genomics Genetics, GSK, Hikma, EVA Pharma, Janssen, Lilly, MSD, Mundipharma, Newbridge, Novartis, Pfizer, Pierre Fabre, and Roche. He received travel grants from Boehringer Ingelheim, Hikma, Janssen, Lilly, MSD, Mundipharma, Novartis, Pfizer, and Roche. He participated as an investigator in clinical trials sponsored by AstraZeneca, Boehringer Ingelheim, Novartis, Pfizer, and Roche. Dr Cagatay Taskiran, Dr. Jamila Riromar, Dr. Mehemet Ali Vardar, Dr. Salha Boujassoum, and Dr. Waleed Bahaj do not have any conflict of interest.Ahmed Aboutaleb, Eman Samy, and Farah Sadek are employees at AstraZeneca.