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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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Instead, re-esterification of FAs is reduced by 25% in T2D adipocytes leading to increased FA levels (190), suggesting the primary defect may be in sequestration of FAs and not lipolysis per se