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Approval to enroll patients in the ENIO main study was obtained from the institutional review board of the promoter center (Groupe Nantais d\u2019\u00c9thique dans le Domaine de la Sant\u00e9, IRB No. 7\/11\/2017) and of each participating center. Informed consent was generally waived in accordance with the observational nature of the ENIO study but if necessary was collected in accordance with the local regulations of each involved institutional review board. Informed consent was obtained from the patient or from the patient\u2019s next of kin in case the patient was unable to give the consent at the time of enrollment.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval\/Informed Consent"}}]}}