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"We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data." FDA noted that two of the nine randomized subjects who received the investigational product were not eligible under the enrollment criteria
Accessed on 27 September 2023
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Interestingly, Sderholm's group in Sweden showed that the TEER and the paracellular passage of 51 Cr-EDTA and FD4 are not altered in the sigmoid colon of UC patients in remission but they have an increased transepithelial flux of the protein antigen HRP
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