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Thirty-two participants completed Phase I, of whom 29 (90.6%) were classified as high-TMAO producers ( 5 mol/L and 50% increase from baseline to 24-h follow-up)

It has been supplied in non-commercial glass brownish bottle containing 10-gm yellow powder and was freshly dissolved in drinking water prior to administration

In the evaluation, the UK authorities did not use an uncertainty factor of two for inter-individual differences in sensitivity as EFSA did

Furthermore, evidence shows that most (up to 95%) pharmaceutical drugs found effective and safe in animal studies fail in subsequent clinical phases in human populations, mainly due to insufficient efficacy, toxicity, and the emergence of unacceptable adverse drug reactions, raising significant concerns for ethical and economic reasons (204211)