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The available human data from published literature and ongoing pregnancy registry studies on use of oxcarbazepine during pregnancy have not demonstrated an increased prevalence of major congenital malformations with first trimester exposure, though they acknowledge that the published studies do have limitations

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Further, the review process was organized using the PICO (Participant, Intervention, Comparison, and Outcomes) framework, as described below: Participants: studies involving male patients or animals with reproductive system diseases or dysfunction