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Can one component of a composite outcome include infant birth outcomes (e.g., preterm birth (PTB), low birth weight (LBW))?

Primary outcomes should include a maternal health outcome. If proposing composite outcomes, applicants should justify the inclusion of each individual outcome, the combination of outcomes, and any weighting of outcomes, and briefly discuss interpretation of the direction of any effect (increase or decrease). Infant outcomes should not be included in composite outcomes. If preterm birth is included in a composite outcome, applicants should indicate whether they plan to undertake analyses of individual components and whether analyses would be powered for any of the individual components.

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