This registry study will continue until such time as the sponsor, Coram Clinical Trials, makes the decision to terminate data collection. At such time all submitting investigators, subjects and the IRB will be notified of study termination. Subject participation will begin from the date they sign informed consent and will continue until the sponsor, Principal Investigator, submitting investigator, or subject decides to terminate their participation or the registry itself is terminated. The authorization by a subject for use of their Protected Health Information (PHI) for the AL1TER Registry has no expiration date.