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Article History

Received: 2 January 2024

Accepted: 4 October 2024

First Online: 21 October 2024

Declarations

:

: Study data were obtained by accessing the case reports received at the National Pharmacovigilance Data base i.e VigiFlow. All cases are anonymous, non-reversible, individually coded, centrally assigned before data storage. According to national data ethics regulations, access to health information is then available to accredited institutions for administrative, healthcare planning, or epidemiological purposes, and only after official institutional authorization.The study was waived by the IRB of the Lebanese International University. This waiver was based on the fact that our study data was obtained by accessing the case reports received at the National Pharmacovigilance Data base i.e. VigiFlow. All cases were anonymous, non-reversible, individually coded, centrally assigned before data storage. According to national data ethics regulations, access to health information is then available to accredited institutions for administrative, healthcare planning, or epidemiological purposes, and only after official institutional authorization. Thus, the need for informed consent to participate was deemed unnecessary, according to both relevant national and international ethical guidelines and regulations. Mainly, the following three factors support the compliance to regulations for this study: nature of the study, data anonymization and no direct patient interaction. Being a retrospective anonymized study in nature, anonymized data was simply analyzed and did not directly involve human subject interventions. As detailed previously, the data was securely processed through a national database to ensure confidentiality and privacy of people involved. No personal identifiable information was disclosed or even used during the data analysis process. Since results obtained from this study were processed from data already available at the National Pharmacovigilance Database, no patient was interacted with for this study. Thus, no direct patient interactions, no interventions nor treatments were administered as part of this study, making any potential risk or harm to participants negligible and even obsolete.

: Not applicable.

: The authors declare no competing interests.