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Background: A new combined oral contraceptive (COC) with a 26-day regimen containing estradiol valerate (EV) and dienogest (DNG), known as Qlaira (and Natazia in the US), was launched in 2009. It was unknown whether this new regimen and combination has an impact on the cardiovascular risk associated with the use of COCs. The INAS-SCORE study was conducted to investigate the cardiovascular long-and short-term safety of the EV/DNG containing COC compared to established COCs. Design/methods: The ‘International Active Surveillance Study–Safety of Contraceptives: Role of Estrogens’(INAS-SCORE) was requested by the Medicines Evaluation Board as a post-authorisation safety study. It was a large, prospective, controlled, noninterventional, long-term cohort study with active surveillance of the study participants. It was conducted in the US as well as in Austria, France, Germany, Italy, UK, Poland and Sweden. Women prescribed a new COC (either first-time user or switcher) were recruited by a network of prescribing physicians. Recruitment started in 2009 and was finished in 2012. Every 6 months during the first two years and yearly thereafter, the woman was contacted and specifically asked about hormonal contraceptive use and serious adverse events. All self-reported clinical outcomes of interest were validated by healthcare professionals. Main clinical outcomes of interest were venous thromboembolism and arterial thromboembolism. The last patient follow-up was finalissed in January 2017. All analyses make allowance for confounding, using multivariate techniques such as Cox regression models. As requested by the …