Ethics and regulatory issues
This study was registered at clinicaltrials.gov (identifier: NCT01730690) and received ethics approval by the “Comité de Protection des Personnes Ile de France CPP 4” (IRB 00003835) (2012-16NI), and the “Commission Nationale de l’Informatique et des Libertés” (CNIL) (EGY/FLR/AR128794).