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A safety review in the Journal of Obesity & Food Metabolism describes six randomized, double-blind, placebo-controlled trials evaluating AOD-9604, including oral dosing studies and longer phase II programs

The approval was backed by the Phase II open-label AGAVE-201 trial, where treatment with a 0.3-mg/kg dose of Niktimvo elicited an overall response rate of 75%, with a median time to response of 1.5 months

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[DOI] [PubMed] [Google Scholar] Wong 2006 Wong SSL, Wilczynski NL, Haynes RB

Testing is the only way to confirm if a deficiency plays a role