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There is no evidence supporting its benefit in non-cholestatic pruritus associated with cirrhosis (4, 20)

Few previous studies have investigated individual compounds as biogenic INPs

The compounds discussed are not approved for human consumption or therapeutic use

"While we acknowledge your response that an abrupt shortening of the enrollment period led to challenges and mistakes, your response is inadequate because, regardless of the length of the enrollment period, you are still responsible for ensuring that subjects meet protocol-specified eligibility criteria before you enroll them into the study," said FDA