Please submit this form if the subject has (at least one of the following): 1) completed the post treatment follow-up period per protocol 2) been lost to follow-up 3) has refused follow-up 4) withdrew consent 5) has died. (Note: If all follow-up for a subject has been completed, all subjects (except those never initiating protocol therapy) must have both an Off Protocol Treatment Summary form and Off Study Summary form submitted.)