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J Pharm Pharmacol 2002

"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

Serrapeptase, nattokinase, N-acetylcysteine (NAC), and EDTA-based formulations degrade the biofilm scaffold, exposing the embedded yeast cells to antifungal agents that would otherwise be ineffective

K23 DK116720-01), in addition to research support by Juvenile Diabetes Research Foundation (JDRF), NIDDK/DiaComp, NIDDK/KPMP, Thrasher Research Fund, International Society of Pediatric and Adolescent Diabetes (ISPAD), Colorado Clinical & Translational Sciences Institute (CCTSI) and Center for Womens Health Research at University of Colorado