Acknowledgements
We thank the participating patients and their families, the investigators and all study centers staff for their contributions to the study, the members of the steering committee, and the members of the data monitoring committee. We thank Sanofi employees, Cartot-Cotton Sylvaine, Christopher Soria, Corona Gainford, Hazel D. Hill, Karen Lam, Nami Tagami, Patrick Cohen and Shinobu Ohshima for their support and contributions. Editorial support was provided in compliance with international guidelines for Good Publication Practice, by Veena Ekbote and Matt Joynson (on behalf of MIMS Ltd), and funded by Sanofi.