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JR-A, MoS, CED, SA, RP and MiS designed the study. JR-A, MoS, CED, MiS and SA coordinated the project. SBK conducted the data acquisition for Danish National Registers, Denmark. RG, AG, GL, OP, CB, GH and GR performed the data acquisition for ARS Tuscany, Italy. VI, CG, YI, MiT and MaT conducted the data acquisition for the Caserta Local Health Agency Record Linkage Database, Italy. EH carried out the data acquisition for PHARMO, Netherlands. GS-G, CR-B, SP, AG-S and FS-S carried out the data acquisition for VID, Spain. PG-P, AL-G, DG-B and MM-P carried out the data acquisition for BIFAP, Spain. MiS and OK managed funding. JR-A, CED, RP, SA, MG and EA wrote and checked the common analysis scripts for distributed analyses and conducted the final aggregated analyses. JR-A, CED, RP, VH and SA were in charge of quality-control processes. All authors contributed to data interpretation. JR-A, MoS, SA, CED and EB wrote the manuscript. All authors contributed to the article and read and approved the final version.","order":1,"name":"Ethics","label":"Author Contributions","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network, which is a public academic partnership coordinated by the Utrecht University, the Netherlands. The project has received support from the European Medicines Agency (EMA) under the Framework service contract nr. EMA\/2017\/09\/PE\/04, Lot 4, Specific Contract 02. This study derives from the fourth objective of the main project (EUPAS31095). The content of this article expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the EMA or one of its committees or working parties.","order":2,"name":"Ethics","label":"Funding","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The datasets presented in this article are not readily available because this study used pseudonymised or anonymised patient data under license from electronic healthcare databases in different countries\/regions. These data remained local within each centre as local data protection regulations for individual data privacy protection apply.","order":3,"name":"Ethics","label":"Data Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All analyses scripts are open source and are publicly available at:\n                      \n                      .","order":4,"name":"Ethics","label":"Code Availability","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Judit Riera-Arnau is a researcher at University Medical Center Utrecht, which receives institutional research funding from pharmaceutical companies and regulatory agencies, administered by University Medical Center Utrecht. All these studies follow the ENCePP code of conduct. Romin Pajouheshnia is an employee of RTI Health Solutions, which is a unit of RTI International, a non-profit organisation that conducts work for government, public and private organisations, including pharmaceutical companies. The remaining co-authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.","order":5,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study was conducted according to the guidelines for Good Pharmacoepidemiology Practice (GPP) [International Society for Pharmacoepidemiology 2008] and according to the ENCePP code of conduct (European Medicines Agency [EMA] 2018). This study was exempt from an ethics review because of its observational nature, anonymised or pseudonimised data use, and aggregated data sharing. STROBE guidelines have been followed. In Denmark, the Danish National Prescription Registry was accessed through the Research Service Unit of Statistics Denmark (FSEID- 00004357\/DST- project no. 707524), and approval for processing of personal health data was obtained through the UCPH (ref. no.: 514- 0301\/19- 3000). In Italy, the participation ARS Toscana and Caserta did not require any further ethical approval. In the Netherlands, the EMA Lot4 study on retinoids has been approved for compliance with the general data protection regulation by the Institutional Review Board of \u2018Stichting Informatie voorziening voor Zorg en Onderzoek\u2019 (dd. 10 October, 2019). In Spain, the favourable approval was received from the BIFAP Scientific Committee (reference num. 19_2019) on 23 February, 2020 and from the Comit\u00e9 de \u00c9tica de la Investigaci\u00f3n Con Medicamentos Regional de la Comunidad de Madrid-CEIm-R on Acta 02\/20) on\u00a010 February, 2020. In the Region of Valencia, the favourable approval was received from the Comit\u00e9 \u00c9tico de Investigaci\u00f3n con Medicamentos del Hospital Cl\u00ednico Universitario de Valencia on 27 February, 2020 (protocol reference CHA-RET-2020-01).","order":6,"name":"Ethics","label":"Ethics Approval","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":7,"name":"Ethics","label":"Consent to Participate","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":8,"name":"Ethics","label":"Consent for Publication","group":{"name":"EthicsHeading","label":"Declarations"}}]}}