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This study was approved by the Ethics Committee (Ile de France Research Subjects Protection Committee VI—ID RCB: 2018-A02434-51, November 21st, 2018). This study was registered on Clinicaltrials.gov: NCT03761654.
Consent for publicationThe manuscript has been read and its submission approved by all co-authors. According to the French law, the patients and/or next of kin were informed about the inclusion of their anonymized data in the database, and none declined participation.
Competing interestsM.B received honoraria from Edwards Lifesciences and Pulsion Medical System as a lecturer. The other authors have no competing interests.
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