The study (NCT02621931; https://clinicaltrials.gov/ct2/show/NCT02621931) was conducted in accordance with the International Conference for Harmonisation guidelines for Good Clinical Practice, the Declaration of Helsinki, and relevant national and local regulations, and it followed the established study protocol [16]. The protocol was approved by relevant ethics committees and institutional review boards, and written informed consent was obtained from each patient prior to performing any study procedures or assessments [16].