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This Joint Undertaking receives support from the European Union\u2019s Horizon 2020 research and innovation programme and EFPIA.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"Florence van Hunsel and Eug\u00e8ne van Puijenbroek are Editorial Board members of\n                      Drug Safety\n                      . These authors were not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Rebecca L. Bromley\u2019s institution received an honorarium from UCB Pharma for her participation in an international women\u2019s health board. Dimitra Gkolfi, Yrea R.J. van Rijt-Weetink, Henric Taavola-Gustafsson, Lovisa Sandberg, Boukje C. Raemaekers, Anneke L.M. Passier and Laura M. Yates have no conflicts of interest that are directly relevant to the content of this article.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Ethics approval was not needed for this study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Not applicable.","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 data that support the findings of this study are not publicly available. Access to the data is restricted based on the conditions for access within the World Health Organization Programme for International Drug Monitoring. 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