Methods
This research complies with all relevant ethical regulations. The SYNERGY trial was approved by the following ethical committees/authorities: Comité d’éthique hospitalo-facultaire Erasme-ULB and Federal Agency for medicines and health products (Belgium), and Comité de protection des personnes Ile de France and Agence nationale de sécurité du medicament et des produits de santé (France).The study design and conduct complied with all relevant regulations regarding the use of human study participants and was conducted in accordance with the criteria set by the Declaration of Helsinki. All patients signed written informed consent before inclusion.The SYNERGY trial was registered on ClinicalTrials.gov (