Study Design and Oversight Between November 2010 and December 2012,69 patients fulfilling inclusion criteria were enrolled from 12 recruiting centers in Spain (Figure 1). The study protocol was approved by institutional review board of each participating center and conducted in accordance with the principles of the Declaration of Helsinki (1996), International Conference on Harmonization Good Clinical Practice, and local and national regulations. All enrolled patients provided written informed consentbefore any study-related procedure was undertaken. The study was registered on the website www.ClinicalTrials.gov (unique identifier: NCT01536132) and the EudraCT database (2009-014242-28). The trial was designed, implemented and overseen by the Steering Committee. On-site monitoring of the study, data collection and data management was performed by a Clinical Research Organization (CRO, 3DHealth). The manuscript was written and submitted by the Steering Committee members. All contributing authors had full access to study data and analyses.