The patients recruitment is close to start in France and in the Netherlands, where the 6 clinical sites (Hopital Robert Debré in Paris, Hopital Necker in Paris, Hopital La Timone in Marseille, Hopital Roger Salengro in Lille, Erasmus Universitair Medisch Centrum Rotterdam-Sophia Kinderziekenhuis in Rotterdam and University Medical Center Utrecht, Wilhelmina Kinderziekenhuis in Utrecht) will receive the SIV (Site Initiation Visit) in September 2016. The other 6 participating sites in Albania (Qendra Spitalore Universitare Nene Tereza), in Germany (Universitaetsklinikum Erlangen), in Greece (Geniko Nosokomeido Paidon I Agia Sofia) and in Italy (Azienda Ospedaliero – Universitaria Consorziale Policlinico di Bari, Azienda Ospedaliera di Padova and Istituto Giannina Gaslini) will receive the SIV in October 2016.
The site initiation visit (SIV) will be attended by the site principle investigator and his/her team of co-investigators and study nurses. During the SIV, the study staff will be trained in study conduct in accordance with Good Clinical Practice (GCP). With the release of the Investigational Medicinal Product (IMP), expected in August 2016, all the sites will be able to start recruitment of first eligible patients.