The reply submission includes results from the recently completed thorough QT (tQT) study, which showed that exenatide, at and above therapeutic levels, did not prolong the corrected QT interval in healthy individuals as defined by the FDA's published guidance. The reply also contains results from the DURATION-5 study, which compared the commercial formulation of BYDUREON to BYETTA® (exenatide) injection. Additionally, it includes an update of safety information from studies ongoing or completed since the last submission, as is standard practice in a complete response scenario.
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