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All information is likely to be kept private. Peer-reviewed publications and presentations will target researchers and health care professionals. TEST REGISTRATION NUMBER The ClinicalTrials.gov registry (NCT03973216). © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Posted by BMJ.OBJECTIVES Orofacial clefts are typical delivery flaws with too little powerful evidence regarding their association