Ethics approval
No Independent Ethics Committee or Institutional Review Board approval was obtained because of the study’s observational design in accordance with the requirements of local law and regulations in France. The protocol was reviewed and approved by a French data privacy committee: Comité Consultatif sur le Traitement de l’Information en Matière de Recherche dans le Domaine de la Santé (CCTIRS) and Commission Nationale de l’Informatique et des Libertés (CNIL). Bayer France received a positive statement from the CCTIRS on June 18, 2014, and an authorization from the CNIL on October 14, 2014, for the RAINBOW study. All patients provided written informed consent for participation in this study.