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The study was approved by the University Hospitals of Cleveland Medical Center Institutional Review Board, approval # 04-16-26, and an Observational and Safety Monitoring Board appointed by the NHLBI and performed in accordance with the Declaration of Helsinki. This study included infants previously enrolled in the Pre-Vent CWRU site study with informed parental consent and whose parents consented to any follow-up.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}}]}}