Table 1.
Schedule of enrollment, intervention, and assessments.
| Item | Before Allocation | Allocation | Post Allocation | Closeout | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Examination | Screening | Enrollment | Visit | |||||||
| 1 | 2 | 3 | 4 | 5 | ||||||
| Time Point (Weeks) | −1 to −4 | −1 | 0 W | 4 W | 8 W | 12 W | 16 W | |||
| Enrollment: | ||||||||||
| Eligibility screen | X | X | ||||||||
| Informed consent | X | |||||||||
| Allocation | X | |||||||||
| Interventions: | ||||||||||
| Placebo group |
|
|||||||||
| LH2171 group |
|
|||||||||
| Assessments: | ||||||||||
| Primary outcome | X | X | X | X | X | X | X | |||
| Secondary outcome | X | X | X | X | X | X | X | |||
| Physical measurements | X | X | X | X | X | X | X | |||
| Physical examination | X | X | X | X | X | X | X | |||
| Urinalysis | X | X | X | X | X | X | X | |||
| blood test | X | X | X | X | X | X | X | |||
| Dietary survey | X | X | X | X | X | X | ||||
| Dairy record |
|
|||||||||
X indicates the timing of each item.