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general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively

If TRIUMPH-3 is not complete by the time of submission, the FDA may require Lilly to submit that data as a post-marketing commitment, which would allow approval to proceed but with conditions

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6.What Is Tirzepatide and How Is It Prepared in a Peptide Solution