Table 2.
Variable | Matrix | Screening | Confinement period | Ambulatory period | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Day −30 to −3 | −2 | −1 | 0 | 1 | 2 | 3 | 4 | 5 | 6 | 30 | 31 | 60 | 61 | 90 | 91 | ||
Safety-related variables | |||||||||||||||||
Vital signs | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ||||
Body height and weight | ● | ● | ● | ● | ● | ● | |||||||||||
Waist circumference | ● | ● | |||||||||||||||
Hematology, clinical chemistry, urinalysis | Blood/urine | ● | ● | ● | ● | ● | ● | ||||||||||
Biomarkers of exposure | |||||||||||||||||
COHb | Blood | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ||||||
Urinary biomarkers of exposure | Urine | ● | ● | ● | ● | ● | ● | ● | ● | ● | ● | ||||||
Risk markers and other clinical markers | |||||||||||||||||
hs-CRP, fibrinogen, homocysteine, LDL cholesterol, HDL cholesterol | Blood | ● | ● | ● | ● | ||||||||||||
sICAM-1 | Blood | ● | ● | ● | ● | ● | |||||||||||
HbA1c | Blood | ● | ● | ||||||||||||||
8-epi-PGF2α and 11-DTX-B2 | Urine | ● | ● | ● | ● | ● |
COHb = carboxyhemoglobin; HbA1c = hemoglobin A1c; HDL = high-density lipoprotein; hs-CRP = high-sensitivity C-reactive protein; LDL = low-density lipoprotein; sICAM-1 = soluble intercellular adhesion molecule-1; 8-epi-PGF2α = 8-epi-prostaglandin F2α; 11-DTX-B2 = 11-dehydro-thromboxane B2. The other variables assessed in this study are listed in the accompanying publication. Only results at baseline (Day 0) and Day 90/91 are reported here.