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We agree with the applicant that SUL-DUR meets the cost criterion and are therefore proposing to approve SUL-DUR for new technology add-on payments for FY 2024 for the treatment of HABP/VABP and bloodstream infections due to Acinetobacter baumannii, subject to the technology receiving FDA marketing authorization for the indication corresponding to the QIDP designation by July 1, 2023

Hayashi et al., 2009

The results were significant: At 48 weeks, participants receiving the 12 mg dose achieved a mean weight reduction of 24.2% (approximately 58 pounds or 26.2 kg) 100% of participants on the 8 mg or 12 mg doses lost at least 5% of their body weight More than 90% of participants on the 12 mg dose lost at least 10% of their body weight Nearly half of participants on the highest dose lost 25% or more of their body weight The study also showed improvements in cardiometabolic markers including blood pressure, triglycerides, LDL cholesterol, and fasting glucose

How much of this is backed by solid research in humans