Funding for this research was provided by:
Received: 12 July 2018
Accepted: 4 June 2019
First Online: 13 June 2019
Ethics approval and consent to participate
: The study was approved by the IRB in the participating centers as follows:IRB at King Abdullah International Medical Research Center (KAIMRC): RC13/116.IRB at King Fahad Medical City (KFMC) (14–165).All the patients were given an approved consent form to participate which was discussed and signed by the patients’ legal guardians before the enrolment.
: The clinical trial and the study medication are funded by Orphan Europe. The scientific design, data management, and data analysis are independent of the funding party.