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As part of the consent form, patients\/parents were informed that the data collected would be used to provide valuable information about long-term outcomes of BPBI in order to inform better treatment options for patients in the future. For this reason the Institutional Review Board at Boston Children\u2019s Hospital determined that the present study using data from the TOBI registry met the regulatory requirements necessary in order to obtain a waiver of informed consent\/authorization.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"This study protocol was reviewed and approved by the Institutional Review Board at Boston Children\u2019s Hospital, protocol number IRB-P00034806.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Study approval statement"}}]}}