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The filing relies heavily on prior regulatory action against Empower, including an FDA warning letter issued after inspectors found that drugs were not stored under sterile conditions

Studies published within the last 10 years to reflect current clinical practices and drug development

A real-world study suggested that over a 5-year period, GLP-1RAs were associated with a reduced risk of prostate, lung and colon cancer compared with metformin, but might be linked to an elevated risk of thyroid cancer (203)

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To our knowledge, this is the first study of the effects of a polyphenol-rich extract on the TMAO response to an OCC