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We previously produced transgenic cattle that were resistant to mastitis by using gene manipulation technology.The resulting uncertainties regarding the safety of milk derived from cloned cattle have to be addressed to obtain the governmental approval and public understanding and support.In this study, an improved safety assessment mice model using a subchronic toxicity experiment was performed to investigate the effects of genetically modified (GM) milk containing human beta-defensin-3 (HBD3) in milk.The mice were divided into control group, GM groups, and non-GM group, and the mice in these groups were respectively fed AIN93G diet, AIN93G diets with addition of 10% or 30% (w/w) GM milk, or AIN93G diets with addition of 10% or 30% (w/w) conventional milk.