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724804.e2, doi:10.1016/b978-0-323-35775-3.00013-8, ISBN 978-0-323-35775-3, PMC 7158316 Histopathology of Preclinical Toxicity Studies (Fourth Edition) , Boston: Academic Press, pp

This condition is known as acid reflux

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If the answer is yes, has the applicant demonstrated that the reductions in exposure are reasonably likely to translate to a measurable and substantial reduction in morbidity and/or mortality