ETHICS STATEMENT
This study was performed in accordance with the Declaration of Helsinki and was consistent with the International Conference on Harmonization Good Clinical Practice Guidelines, applicable regulatory requirements and the sponsor's policy on Bioethics and Human Biological Samples. The study protocol, its amendments, the informed consent form, and any information provided to the patients were approved by an independent ethical committee or institutional review board at each study center. The approval numbers for each study center are listed in Table 