Ethical Considerations
The trial was conducted in accordance with the Declaration of Helsinki of 1975, as revised in 2008, and the International Conference on Harmonization Good Clinical Practice guidelines for biomedical research. The “Sud-Méditerranéen I” Regional Ethics Committee approved the study on February 14, 2018 (2017-A02701-52), and the Agence Nationale de Sécurité du Médicament approved it on March 9, 2018. All patients provided written informed consent.