Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
Assessment time points
| Visit (V) | Assessment time points | |||
| Screening | V1 | V2 | V3 | |
| Time per study site session | ||||
| Week | Week 0 | Week 16 | Week 20 | |
| Enrolment and randomisation | ||||
| Eligibility assessment | X | |||
| Randomisation | X | |||
| Implementation | ||||
| Questionnaire | X | |||
| Blood collection | X | X | X | |
| Adverse event reporting | X | X | ||
| Supplementation | ||||
| Tablet distribution | X | |||
| Tablet count | X | |||
