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38 Under the catalysis of LTC4S (leukotriene C4 [LTC4] synthase), which is a -glutamyltransferase and membrane-bound dipeptidase, leukotriene A4 can also produce a series of cysteine-containing leukotrienes (cysLTs), such as LTC4, leukotriene D4, and leukotriene E4

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"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

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