Ethics approval and consent to participate {24}
The HOPEext study protocol was approved by a human research ethics committee (Comité de Protection des Personnes Ile de France III) on June 5, 2019, under the reference number 3688-I. The trial also received approval from the French regulatory agency (Agence National de Sécurité du Médicament) on June 20, 2019 (190004B-13). Written informed consent will be obtained from all participants.