Fig. 3.

Summary schedule of study assessments. 1, 2: Urinalysis and Pregnancy test can be repeated in other visits as clinically indicated. 3: If subjects do not have a chest x-ray or hands/ft x-ray performed within 3 months of screening, an x-ray should be performed after it is certain the subject meets the inclusion/exclusion criteria in order to minimize exposure to ionising radiation. 4, 5: Whole-body magnetic resonance imaging (WB-MRI) and ultrasound (US) scans should be performed within 10 days before or after the scheduled visit attendance. Baseline assessment can take place 10 days before, but not after, the scheduled visit attendance. 6, 7: No imaging (WB-MRI and/or US) to be performed if withdrawal visit occurs after week 36 or if within 6 weeks of last imaging. 8. Investigational Medicinal Product (IMP) administration should be every 4 weeks. In the case of a missed dose of IMP, the IMP can be administered up to 2 weeks after the scheduled visit. If a dose of IMP is delayed for more than 2 weeks, the IMP should not be administered until the next scheduled visit. Exposure to IMP should be captured in the medication workbook. * Study week X: withdrawal or early discontinuation. Subjects who discontinue prematurely during Period 1 should return for the same assessments associated with Week 24 visit