 Although every effort will be made to encourage subjects to keep regularly scheduled appointments, in the event that a subject is unable to come into the office within a reasonable timeframe of a scheduled visit, and the treating research clinician feels that subject safety will not be jeopardized by doing so, the clinician can conduct the visit with the subject over the telephone. However, study evaluation visit pre-baseline, baseline visit, mid-point visit week 3, or the final study visit may not be conducted over the phone. Additionally, phone visits may not occur for two consecutive visits. 