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Statements Author contributions CV and MC conceived of and designed the study

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Therapeutic area: Diabetes mellitus, type 2 This multi-part report includes: A1C glycated hemoglobin AE adverse event CI confidence interval CV cardiovascular CVOT cardiovascular outcomes trial DB double blind DPP-4 dipeptidyl peptidase-4 DULA dulaglutide eGFR estimated glomerular filtration rate EMA European Medicines Agency EMPA empagliflozin FDA Food and Drug Administration FPG fasting plasma glucose GLP-1 RA glucagon-like peptide-1 receptor agonist HRQoL health-related quality of life ITT intention-to-treat population LIRA liraglutide MET metformin NYHA New York Heart Association OAD oral antidiabetic PP per-protocol RCT randomized controlled trial SAE serious adverse event SC subcutaneous SD standard deviation SE standard error SEM semaglutide SGLT2 sodium-glucose cotransporter-2 SU sulfonylurea T2DM type 2 diabetes mellitus TEAE treatment-emergent adverse events TZD thiazolidinedione WDAE withdrawal due to adverse event An overview of the submission details for the drug under review is provided in Table 1