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Apart from these cardiovascular mechanisms, increased BMI independently correlates with mortality risk

In a briefing document released prior to the panel discussion, the FDAs internal reviewers said that Ocaliva had failed to demonstrate efficacy in one of its confirmatory trials

In recent GLP-1RA trials focusing on patients with obesity, favourable effect on worsening heart failure in HFpEF patients was indicated to be modulated by baseline BMI [32], although the underlying mechanisms that explain the cardiovascular and renal benefits may not necessarily be due to weight loss alone

Cases involving diagnosed gastroparesis, bowel obstruction, gallbladder surgery, or documented NAION-related vision loss are generally expected to carry higher projected values than cases involving temporary or less severe complications

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