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Subjects with high cardiovascular risk and BMI of 40 kg/m2 were excluded from the trial because of potential complications that could act as confounding factors

Patients with active cancer, certain endocrine conditions, pregnancy, or specific medication interactions need a different approach

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We continue to recognize the need for a payment policy that accounts for the unique and heterogenous characteristics of SaaS, and we remain interested in ensuring that any such payment policy reflects the value provided to Medicare providers and beneficiaries