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In addition, the Belgian Information Security Committee judged this study positively on its proportionality and finality to use personal and medical data (IVC\/KSZG\/21\/312). In the same context, a third party, the Belgian Health Care Knowledge Centre (KCE) performed a small-cell risk analysis to evaluate the risk of unintentional disclosure of personal information versus the proportionality and finality of the study. For variables with a risk of individual identification, such as sex at birth and residency, we received data in aggregated format. IMA pseudonymized all data and converted exact dates of first PrEP dispensing into month-year dates and for all other healthcare expenditures the number of days since first PrEP dispensing were registered to secure the privacy of each individual. As outlined in Article 14(5)(b) General Data Protection Regulation - European Regulation 2016\/679 of April 27, 2016, and confirmed by the Institutional Review Board and Belgian Information Security Committee, the data controller is exempt from the obligation to provide information to the individuals whose personal data is processed.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The institution of M. F. Schim van der Loeff received study funding from Sanofi Pasteur MSD, Janssen Infectious Diseases and Vaccines and GSK; he was a co-investigator in a Merck-funded investigator-initiated study; he was an investigator on a Sanofi Pasteur MSD sponsored trial; he served on advisory boards of GSK and Merck. The institution of TR received fees from GSK\/ViiV for attending advisory boards. All other authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"2296"}}