Al-Homood, Ibrahim A. https://orcid.org/0000-0001-6391-6938
Alajlan, Mohammed https://orcid.org/0009-0007-5497-0458
Alberdisi, Majid https://orcid.org/0000-0001-8149-8944
Alturki, Mohammad https://orcid.org/0009-0004-5072-3722
Ahmed, Ahmed Ali https://orcid.org/0000-0003-4319-8232
Zakaria, Nancy https://orcid.org/0009-0008-9378-740X
Funding for this research was provided by:
Novartis pharmaceuticals
Article History
Received: 15 October 2023
Accepted: 6 April 2024
First Online: 29 April 2024
Declarations
:
: This study was conducted in accordance with the protocol, the Guidelines for Good Pharmacoepidemiology Practices (GPP) of the International Society for Pharmacoepidemiology (ISPE 2008), the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines, and the ethical principles laid down in the Declaration of Helsinki. All study data were accessed in accordance with ethics and research governance requirements. No patient identifiers were collected to ensure the complete protection of patients’ privacy. The study was approved by the local institutional review board (IRB) at King Abdulaziz City for Science and Technology (KACST) with registration number <b>H-01-R-012</b>. Additionally, the IRB registration number with OHRP/NIH, USA is <b>IRB00010471</b>, while the approval number Federal Wide Assurance NIH, USA is <b>FWA00018774</b>.
: Not applicable.
: NZ, AA and MA are employees of the company Novartis Pharmaceuticals. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. IA is an employee of KFMC, has received grant/research support from Novartis, GSK and Pfizer and speaker honoraria from Pfizer, AbbVie, GSK, Novartis, Eli Lilly.