Table 2.
Characteristics of subjects eligible for screening based on protocol and patient-related factors
| Screening | Number(N) | Percentage(%) |
|---|---|---|
| Total screened | 216 | |
| Protocol-related | ||
| Abnormal labs at screening (LFTs,other) | 10 | |
| PSA >10 | 3 | |
| Participation in another trial | 9 | |
| Withdrew consent | 5 | |
| After consent, subject found ineligible | 2 | |
| Total not screened due to protocol-related factors | 29 | 14 |
| Subject-related | ||
| Language barrier | 3 | |
| Travel | 12 | |
| Time commitment | 14 | |
| Participation in a randomized trial (did not want to get the placebo) | 7 | |
| Did not want to change current regimen | 13 | |
| Did not want to have additional biopsies | 5 | |
| Financial concern | 1 | |
| Unknown reason | 58 | |
| Total not screened due to patient-related factors | 113 | 52 |
| Total number of subjects consented for screening | 74 | 34 |