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South Africa: National Department of Health; 2018."}],"container-title":["Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-020-00987-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40264-020-00987-4\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40264-020-00987-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,24]],"date-time":"2021-08-24T23:59:35Z","timestamp":1629849575000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40264-020-00987-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8,25]]},"references-count":51,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,1]]}},"alternative-id":["987"],"URL":"https:\/\/doi.org\/10.1007\/s40264-020-00987-4","relation":{},"ISSN":["0114-5916","1179-1942"],"issn-type":[{"value":"0114-5916","type":"print"},{"value":"1179-1942","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8,25]]},"assertion":[{"value":"25 August 2020","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"This work was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01HD080465).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Ushma Mehta, Mariette Smith, Emma Kalk, Helen Hayes, Annoesjka Swart, Lawrence Tucker, Renier Coetzee, Andrew Boulle, and Marc Blockman have no conflicts of interest to disclose.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"Approval for this study and its subsequent publication was granted by the University of Cape Town Faculty of Health Sciences Human Research Ethics Committee (ref: 098\/2018) and the Western Cape Provincial Research Committee.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable. Anonymised, aggregate data extracts and statistics aimed at addressing the key objectives of the study will be generated by the PHDC for review by the investigators. The research is retrospective, observational, part of standard of care, and involves no additional risk to patients. Only anonymised data will be provided to the investigators.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The datasets generated during and\/or analysed during the current study are not publicly available as these data are in the custody of the Provincial Government of the Western Cape of South Africa and permission for access to such data would need to be sought directly from the Provincial authorities.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material"}},{"value":"SQL Server 2017 was used to generate the relevant outputs from the PHDC. This code can be made available on request from the corresponding author.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability (software application or custom code)"}},{"value":"UM, MS, AB, MB and EK developed the study concept; MS and UM conducted the data mining and analysis; and UM drafted the manuscript, which was reviewed and edited by all authors.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Author contributions"}}]}}