Wakao, Rika http://orcid.org/0000-0002-3888-381X
Lönnstedt, Ingrid M.
Aoki, Yasunori http://orcid.org/0000-0002-5881-2023
Chandler, Rebecca E. http://orcid.org/0000-0002-9334-9046
Article History
Accepted: 7 March 2021
First Online: 10 April 2021
Declarations
:
: Neither Rika Wakao (RW), Ingrid M. Lönnstedt (IL), Yasunori Aoki (YA) nor Rebecca E. Chandler (RC) have received specific grants from any funding agency in the public, commercial, or not-for-profit sectors.
: Neither RW, IL, YA nor RC have no conflicts of interest that are directly relevant to the content of this study. YA is currently employed by AstraZeneca; however, his contributions to this work were made prior to the start of the employment at AstraZeneca, as part of his employment at Uppsala Monitoring Centre and his appointment at the National Institute of Informatics.
: Institutional review board approval was not required because VigiBase is an un-linkable anonymized database of WHO.
: Consent to participate was not required because VigiBase is an un-linkable anonymized database of WHO.
: RW, IL, YA and RC have the support of their respective institutions for publication of this manuscript. All authors read and approved the final version.
: The datasets generated and analysed during the current study are not publicly available due to agreements between contributors of data to the database used (VigiBase) and the custodian of this database. National centres (mainly national drug regulatory authorities) constituting the WHO Programme for International Drug Monitoring (PIDM) contribute data to VigiBase and the Uppsala Monitoring Centre is the custodian in its capacity as the WHO Collaborating Centre for International Drug Monitoring. Some subsets of the data may be available from the corresponding author on reasonable request.
: Code used in the extraction and analysis of data is available upon request.
: RW, RC and IL wrote the manuscript; RW came up with the study concept; RW, RC, IL and YA designed the research; RC and IL performed the research; IL and YA performed the data analyses and IL contributed analysis methods and graphical overviews. All authors read and approved the final version.