Author contributions
The study was sponsored and designed by Novartis Pharmaceuticals Corporation and Novartis Pharma KK and was approved by the Institutional Review Board at each participating institution. NF, KK, HG, KA, TT, HH enrolled and treated patients, and compiled the data. Data were analyzed and interpreted by the sponsor and all the authors. All authors interpreted the data, participated in writing the article, provided feedback throughout the development process, and approved the final submitted version.