Received: 14 September 2021
Accepted: 11 January 2022
First Online: 27 February 2022
: The HIGH Randomized Clinical Trial protocol was approved by the CPP Ile de France IV St-Louis ethics committee(March3, 2016, <i>#</i>NIRB00003835/2016/08) and French health authorities(Agence Nationale de Sécurité du Médicament et des Produits de Santé, EudraCT2016-A00220-51). Informed consent was obtained from all subjects or their legal guardian. All methods were carried out in accordance with relevant guidelines and regulations.
: Not applicable.
: The authors declare that they have no competing interests.