Study Visits. Upon signing of the informed consent, patients will enter a 1-4 week period of screening and prestudy training. Patients will be trained on self-administration of study drug and on recording of medication usage and local tolerance. After eligibility is assessed during the Screening period, a one week Pretreatment period is used to collect baseline data. Once enrolled, patients will return to their study center for safety and efficacy assessments at baseline (Day 1) and 1, 3, 6, 9, 12, and 18 months, and at any other time as warranted by safety, efficacy or compliance concerns. A final study visit is planned one month after the last dose of study drug. The study periods and number of clinic visits are summarized below:
Appears in 3 contracts
Sources: Work Statement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)