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The approval stems from the Phase IIIb SOUL trial involving over 9,600 patients, which showed MACE occurred in 12% of Rybelsus-treated patients versus 13.8% on placeboa statistically significant 14% treatment effect

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Once reconstituted (if provided in lyophilized form), follow your pharmacy instructions for post-reconstitution storage

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that is, patients who had not used either drug class at any time before cohort entry