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Dig Dis Sci

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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

[3] Drucker DJ

A plausible mechanism does not establish an effective ratio, compatibility, long-term safety or a clinically meaningful result