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Finally, outcomes that occurred outside participating institutions may not have been captured, potentially leading to under-ascertainment of pregnancy or delivery events

Whether the FDA extends the same designation to retatrutide depends on whether the agency considers the Phase 3 data to represent a substantial improvement over existing therapies

All animal studies were conducted in accordance with the principles and procedures outlined in the Guide for the Care and Use of Laboratory Animals and approved by the Institutional Animal Care and Use Committee (IACUC) of the Clinical Center, National Institutes of Health (the approved number is NIBIB 1501)

2 Data show that more than 50% of patients started on monotherapy will require a second medication to control diabetes after three years