Funding for this research was provided by:
FP7 Health (279093)
Received: 9 July 2019
Accepted: 23 March 2020
First Online: 30 March 2020
Ethics approval and consent to participate
: Ethical approval for the trial was granted from the appropriate National Competent Authorities, Independent Ethics Committees and Institutional Review Boards for all study sites. Ethical Approval for the study also included secondary analysis of NILVAD study data. Written consent was obtained from each participant/caregiver. Individual ethics committees that approved the original trial protocol are as follows: Comite de Protection des Personnes Nord Ouest III, Scientific Council of Papanikolaou Hospital Thessaloniki, Radbound Universitar Medisch Centrum, Concernstaf Kwaliteit en Veiligheid Comissie Mensgebonden Onderzoek Regio Arnhem-Nijmegen, Medical Research Council Ethics Committee for Clinical Pharmacology (KFEB), Comitato Etico Istituzioni Ospedaliere Cattoliche (CEIOC), Comitato Etico IRCCS MultiMedica, Camitato Ethico dell’Aienda Ospedalier a Universitaria S Martino di Genova, Comitato Etico Regione Liguria, Comitato Etico Fondaione Don Carlo Gnocchi.
: Not applicable.
: The authors declare that they have no competing interests.