The subjects adhered to a total of four visit intervals for screening (visit 1 week 1 to week 2)recording of measurements at baseline (visit 2 day 0)at week 6 (visit 3 day 42
3 day) and end of study at week 12 (visit 4 day 84
3 day) followed by a follow-up visit (visit 5 week 14 viatelephone or face)