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These CVOT findings are supported by a real-world study performed in over 3 million patients with T2DM from the United States, in which patients treated with SGLT2is did not have a higher risk of any or lower amputation compared with incretins or other glucose-lowering agents [77]
Sies H (1985) Oxidative stress: introductory remarks
2 For a 505(b)(2) sponsor, these new indications represent a value continuum where they can repurpose an established molecule for a specialized population with much lower risk
Analyses were guided by the treatment policy estimand that represents the efficacy irrespective of adherence to study intervention
It also allows for rotation between multiple sites, reducing the risk of localized reactions
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