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Sample Trial: During the Study
The study will last 12 months. You will be asked to visit the study researcher about six times during that year. The first visit will last about three to four hours. The other visits will last about one to two hours. These visits will occur at the following times:
- Visit 1 -- At the beginning of the study
- Visit 2 -- After one month
- Visit 3 -- After three months
- Visit 4 -- After six months
- Visit 5 -- After nine months
- Visit 6 -- After 12 months (the final visit)
At each visit, the study researcher or staff may do any or all of the following:
- Medical history, review of eligibility criteria (visit 1)
- Urine pregnancy test (visit 1 and any time pregnancy is suspected for women of childbearing potential)
- Height (visit 1)
- Physical examination, vital signs, weight (all six visits)
- Blood draw (all six visits)
- Urine tests (visits 1 and 6)
- Complete a questionnaire about possible side effects (all six visits)
In addition, the study researcher or staff will contact you by telephone to ask how you are doing during months two, four, dive, seven, eight, 10, and 11 of your participation in the study. If you drop out of the study before it is completed, you will be contacted (unless you choose otherwise) on what would have been your 12-month visit to ask how you are doing.
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