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The reason for this extension is due to Patent Term Adjustments (PTA) and Patent Term Extensions (PTE) that the law provides for any delay in patent examination at the United States Patent and Trademark Office (USPTO) and regulatory approval by the U.S

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The D-Ala substitution provides dual benefits: modest intrinsic potency enhancement (3-fold in vitro) plus substantial protection against dipeptidylpeptidase IV (DPP-IV) degradation, which normally cleaves between positions 2 and 3