The study aims to initially enroll 1500 patients from 3-15 sites in the United States, identified by Genelex. The study may be expanded up to 10,000 patients at additional sites in the United States. The study duration is estimated to be at least 15 months, including 3 months for study set-up, 6 months or longer for patient enrollment depending on the rate of accrual at each site, 4 months of per-patient follow-up and 2 months for study closeout.