Study Oversight and Data Availability
The study was performed in accordance with the Declaration of Helsinki statement on ethical biomedical research and with the International Conference on Harmonization Guidelines for Good Clinical Practice. The study was approved by the local Institutional Review Boards for each study site. All patients provided written informed consent. The trial is registered at ClinicalTrials.gov (NCT03422679) and the full protocol is provided in the Supplementary Materials and Methods. The data generated in the study are available within the article and from the corresponding author upon request.