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The primary endpoint was steady-state semaglutide exposure, defined as the area under the curve over a dosing interval at steady state (AUC 0168 h,SS )

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(linked study) Urva S, et al

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women

Ultimately, this has made it a challenge for decision-makers at businesses in the U.S