Assessments
Assessments were performed at baseline and at 6 and 12 months. Body weight was also measured after 3 months to detect short-term changes. Laboratory assessments were only performed at baseline and 12 months. Participants received €30 (US $32.9) compensation for their participation in the study at baseline and at 6 and 12 months in €10 (US $11.0) vouchers at each time point. Assessments were conducted by trained FACT team staff. Research staff helped to conduct assessments when there was a shortage of FACT staff.