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Carlsson 2018 - body-weight exposure covariate

The pivotal trial supporting its 2010 FDA approval enrolled 816 HIV-infected adults with clinically defined lipodystrophy, and Phase 3 data documented visceral fat reductions of roughly 15-18% over 26 weeks of treatment a result robust enough to clear FDA review for a defined medical indication

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8 A case-control study that compared 25,956 patients who had vitamin B 12 deficiency with 184,199 control patients found a significantly increased risk of vitamin B 12 deficiency in patients who had taken proton pump inhibitors (odds ratio = 1.65) or histamine H 2 blockers (odds ratio = 1.25) for at least two years

This side effect deserves attention because it can significantly impact quality of life and exercise capacity