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Regulatory bodies may require a dedicated cardiovascular outcomes trial before or after full approval is granted consistent with the precedent set for other agents in this class though the precise regulatory requirements will be determined by the MHRA and EMA based on the totality of evidence submitted

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It is the first randomised study to investigate the effects of semaglutide, empagliflozin and their combination on DWI-MRI-derived kidney parameters in a type 2 diabetes population at high cardiovascular risk