This multi-center trial will be conducted in the United States. The maximum treatment duration in this study is up to 12 months and overall time to participate in the study is approximately up to 40 months. Participants will make 31 visits to the clinic, and will be contacted every 12 weeks for post treatment follow-up. Participants will be followed up for survival until death, loss to follow-up, consent withdrawal, or study termination by the sponsor, whichever occurs first.