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The effectiveness of RYBELSUS (formulation R2 - 1.5 mg, 4 mg and 9 mg strengths) [see Dosage and Administration (2.2)] and RYBELSUS (formulation R1 - 3 mg, 7, mg and 14 mg strengths) [see Dosage and Administration (2.3)] has been established as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus based on adequate and well-controlled studies of RYBELSUS (formulation R1) in adult patients with type 2 diabetes mellitus [see Clinical Pharmacology (12.3)]