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While observational studies report associations between bariatric surgery or intentional weight loss and reduced mortality, no randomized clinical trials show that weight loss therapies augment CV outcomes

[DOI] [PubMed] [Google Scholar] 156.Kohalmy K, Tamasi V, Kobori L, Sarvary E, Pascussi JM, Porrogi P, Rozman D, Prough RA, Meyer UA, Monostory K

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Sponsors generally need to demonstrate that the benefit-risk balance is positive even on incomplete data, and the reasonable likelihood standard in the EU is interpreted more conservatively than in the U.S

Available online: [DOI] [PMC free article] [PubMed] 17.Naftali T., Yishai R., Zangen T., Levine A
