If eligible they will return for a History and Physical visit not less than 13 and not more than 28 days from screening visit. Enrollment will occur 2 weeks after the History and Physical visit. The first 10 daysof study will be as an inpatient followed by weekly visits for 16 weeks, then monthly visits for 14 months. In unusual circumstances, the inpatient period can be arranged as outpatient monitoring. During the first 10 days after enrollment the patient may undergo optional semen or genital secretion collection.
Remuneration is provided for optional procedures.