Table 2.
Name | Events | Day | |
---|---|---|---|
Visit 1 | Screening | Inclusion/exclusion criteria reviewed, informed consent obtained, medical history and exam, vital signs and blood safety sample taken, fecal collection kits and diaries provided | −30 to −14 days |
Visit 2 | Baseline | Inclusion/exclusion criteria, dietary supplements and medications, and medical history reviewed, pregnancy test (females only), fecal sample and diaries collected, randomization | Day 0 |
Visit 3 | Week 1 | Fecal sample and diaries collected, unused study products collected, compliance calculated, and product re-dispensed, review medication and dietary supplement history, new fecal collection kits and diaries dispensed | ~Day 8 (+2 day window) |
Visit 4 | Week 4 | Fecal sample and diaries collected, unused study products collected and compliance calculated, review medication and dietary supplement history | ~Day 29 (+3 day window) |
Visit number, corresponding event, and respective day number for the major activities during the trial.