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The study was registered with ClinicalTrials.gov under the number NCT02867644, and was approved by the Ethics Committee CPP (Comité de Protection des Personnes) Est III on 3 May 2016 under the number ID-RCB: 2016-A00232-49, and by the French Agency for Health Products Safety (ANSM) on 22 April 2016 under the number 160225B-31. All patients were informed about the study and all provided written informed consent. The study was financed by the national hospital nurse & paramedical research programme (Programme Hospitalier de Recherche Infirmière et Paramédicale – PHRIP; grant obtained in 2015).
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