Methods
Cancer
CANCER
The study was conducted at two centers in the United States: The University of Texas MD Anderson Cancer Center and The Ohio State University Comprehensive Cancer Center. All patients provided written informed consent at the time of enrollment stating that they were aware of the investigational nature of the study. The study was approved by the institutional review boards of both institutions and conducted in accordance with the ethical principles of the International Council for Harmonization Guideline for Good Clinical Practice, the Declaration of Helsinki, and applicable local regulations. The study was registered at 