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.10.1177_2055102914567972 [DOI] [PMC free article] [PubMed] [Google Scholar] 34.Timpel P, Cesena FHY, da Silva Costa C, Soldatelli MD, Gois E, Castrillon E, Daz LJJ, Repetto GM, Hagos F, Castillo Yermenos RE, Pacheco-Barrios K, Musallam W, Braid Z, Khidir N, Romo Guardado M, Roepke RML

Regulatory approval requires extensive human testing to establish safety, dosing, and therapeutic benefit

Dietary supplementation of mice with BB was shown to produce both TMA and TMAO, and to accelerate atherosclerosis, but only in the presence of gut microbiota (26)

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These include early pharmacokinetic limitations, inadequate receptor selectivity, poorly chosen clinical endpoints, or the absence of enabling technologies at the time of initial evaluation