Abstract

a Novartis Institutes for BioMedical Research, Preclinical Safety, 4002 Basel, Switzerland b Public Interest Incorporated Foundation BioSafety Research Center, Iwata, Japan c National Institute of Health Sciences, Division of Genetics & Mutagenesis, 1-18-1 Kamiyoga, Setagaya-ku, Tokyo 158-8501, Japan d Federal Institute for Drugs and Medical Devices (BfArM), Bonn, Germany e Exponent, Inc., Center for Toxicology & Mechanistic Biology, Midland, MI 48640, USA f Pharmaceutical Sciences, Roche Innovation Center, F Hoffmann-La Roche AG, CH 4070 Basel, Switzerland g Office of Science Policy, Office of Research and Development, U.S. Environmental Protection Agency, Room 51134 RRB, 1200 Pennsylvania Avenue NW (8104R), Washington DC 20460-0001, USA h Safety Research Laboratories, Mitsubishi Tanabe Pharma Co., Chiba 292-0818, Japan i Kirkland Consulting, PO Box 79, Tadcaster LS24 0AS, UK

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