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But human observational evidence is increasingly reassuring on major malformations when confounding is handled carefullyfor example, large datasets show no substantial increased risk of major congenital malformations with early exposure, and a European teratology cohort reported no increase in major birth defects vs diabetes/high-BMI comparators

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Trial registration ClinicalTrials.gov Identifier: NCT05053841/Registered September 23, 2021 - Retrospectively.

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