Trial Features:
* Medical device (Non-drug option)
* Most patients can remain on current treatment regimen throughout the study
Components of the Study:
* Study length is 24 weeks, which includes a screening visit, ten treatment visits over nine weeks and 4 follow-up appointments
* Physical exams, laboratory tests and disease assessments conducted at no charge to the patient
* 2:1 Randomization (treatment:sham)
* Open-Label extension offered to eligible patients
