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However, neither the innate nor the adaptive immune response is affected by the DPP-4 inhibitors being used clinically (128), and reassuringly, there is no evidence for any increased risk of infections in the pooled safety analyses (119123) or in the CV safety outcome trials (125127), in line with the view that the catalytic activity of DPP-4 is not necessary for the co-stimulatory role of CD26 in T-cell activation

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If the brand files a patent infringement lawsuit within those 45 days, FDA approval of the ANDA is automatically stayed for up to 30 months [5]