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Phase 3 studies are designed to confirm efficacy and safety across larger, more diverse patient populations and will ultimately determine whether Phase 2 findings translate into broader clinical use

Individual compound safety profiles exist

If medication is needed, selective serotonin reuptake inhibitors (SSRIs) are the first-line pharmacological treatment

Sitagliptin, a dipeptidyl peptidase-4 inhibitor, was selected as an active-comparator placebo proxy because it was recommended in clinical guidelines as a second-line glucose-lowering therapy, had a similar high cost to the study drugs, showed no effect on cardiovascular outcomes in a large randomized controlled trial and has been validated as a placebo proxy in prior claims-based research 20,41