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Mojsov points out that the speed with which this happened was because 'At that time you didn't need to get FDA approval for clinical studies of the material being tested at the same institution where the studies were carried out

N Engl J Med 385(16):14511461 Nassif ME, Windsor SL, Borlaug BA, Kitzman DW, Shah SJ, Tang F, Khariton Y, Malik AO, Khumri T, Umpierrez G et al (2021) The SGLT2 inhibitor dapagliflozin in heart failure with preserved ejection fraction: a multicenter randomized trial

Hence the Research Data Governance of the Clinical Practice Research Datalink and the Research Ethics Board deemed it to be exempt from the need to obtain patient consent

55 LudwigM.TodorovP.EgerodK.OlsonD.PersT

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