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Am J Gastroenterol 92:5S-11S Savilahti E, Orml T, Saukkonen T et al (1999) Jejuna of patients with insulin-dependent diabetes mellitus (IDDM) show signs of immune activation

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Concerned that the positive trials might have occurred by chance and the amount of countervailing evidence, the FDA rejected the New Drug Application from the sponsor 4 times (Organon in 1999, 2002, and 2004, and Fabre-Kramer Pharmaceuticals, Inc in 2007)

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