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Article History

Accepted: 18 October 2022

First Online: 2 December 2022

Declarations

:

: This study was not supported by any funds or grants.

: None of the authors have any relevant conflicts of interest to disclose.

: This study did not require ethics committee approval as it did not involve active personal participation or any identifiable medical data. VigiBase^® is a fully de-identified database maintained by the UMC. According to VigiBase^® access rules, no specific ethics approval is needed.

: This study did not require consent to participate as it did not involve active personal participation or any identifiable medical data.

: Not applicable.

: Not applicable.

: VigiBase^® access is granted to national and regional pharmacovigilance centers such our team. Aggregated data of spontaneous reports are available at .

: F. Kaguelidou conceptualized and designed the study, supervised the data analysis, interpreted the results, and drafted the initial manuscript and all revised versions. L. Chouchana participated in study design and data extraction, supervised data analysis, participated in interpretation of results, and reviewed and revised the manuscript. Z. Valtuille performed statistical analyses, and reviewed and revised the manuscript. F. Montastruc and G. Durrieu participated in study design and interpretation of results and critically reviewed and revised the manuscript. R. Delorme, H. Peyre and J-M. Treluyer participated in interpretation of results and critically reviewed and revised the manuscript. All authors read and approved the final version.

: Information from VigiBase^® comes from a variety of sources and the probability that the suspected adverse effect is drug related is not the same in all cases. The information does not represent the opinion of the Uppsala Monitoring Centre (UMC) or the World Health Organization and only reflects the authors’ opinion.