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•Clinic visits during screening, randomization, week 1 and month 2 & every 6 months •Laboratory assessments at visits •participation is between 3 and 5 years
Lab testa while in hospital & at home (phlebotomist will visit your home (day 2,3,& 7). Lab testing at 90-day clinic visit Other phone calls & clinic visits
Data collection will occur from the procedure notes, at 30 days, 6 months, 12 months, 24 months and 36 months.
•Screening visits & Clinic visit at 3m, 6m and 12m. After 1 year Clinic visits every 6m and telephone follow-ups every 6m •participation: up to 5 years
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