Table 2. Schedule of assessments.
Period (duration) |
Open Label Treatment Period (10 Weeks) |
Double-Blind Period (4 Weeks) |
|||||
---|---|---|---|---|---|---|---|
Week | 0 (Baseline) | 2 | 4 | 6 | 8 | 10 | 14 |
DEXA | X | X | |||||
Behavioral questionnaire | X | X | |||||
Fasting glucose | X | X | X | X | X | X | X |
Ghrelin, leptin, triglycerides, Total C, LDL-C, HDL-C, non-HDL-C, comprehensive metabolic panel | X | X | X | ||||
Hyperphagia questionnaire | X | X | X | X | X | X | X |
Resting energy expenditure, respiratory quotient | X | X | X | X | X | ||
Pharmacokinetic blood sampling | X | X |