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Key trials included SUSTAIN 6, a cardiovascular outcomes trial demonstrating significant reduction in major adverse cardiovascular events (MACE) compared to placebo (HR 0.74

At the end of the trial, fecal samples revealed that the GI tract of all 16 test subjects were colonized with ME-3

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Importantly, many of the earlier concerns were derived from animal models or spontaneous adverse event reporting systems, which are limited by their observational nature and lack of control groups (Miyagawa et al., 2015)