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. 2022 Mar 21;18(3):187–197. doi: 10.1007/s13181-021-00873-0

Table 2.

Demographic and baseline physical characteristics by dosing sequence population: safety.

Dosing sequence A
N = 5
Dosing sequence B
N = 5
Dosing Sequence C
N = 5
Overall total
N = 15
Characteristics
Sex, n (%)
Male 5 (100.0%) 1 (20.0%) 2 (40.0%) 8 (53.3%)
Female 0 4 (80.0%) 3 (60.0%) 7 (46.7%)
Age (years)
Mean 37.2 29.2 35.0 33.8
SD 7.5 5.8 3.9 6.5
Race, n (%)
American Indian or Alaska Native 0 0 0 0
Black or African American 2 (40.0%) 3 (60.0%) 3 (60.0%) 8 (53.3%)
Asian 0 0 0 0
Native Hawaiian or other Pacific Islander 0 0 0 0
White 1 (20.0%) 2 (40.0%) 2 (40.0%) 5 (33.3%)
More than one race 1 (20.0%) 0 0 1 ( 6.7%)
Missing 1 (20.0%) 0 0 1 ( 6.7%)
Ethnicity, n (%)
Hispanic or Latino 1 (20.0%) 0 1 (20.0%) 2 (13.3%)
Not Hispanic or Latino 4 (80.0%) 5(100.0%) 4 (80.0%) 13 (86.7%)
Not reported 0 0 0 0
Baseline Weight (kg)
Mean 72.8 77.7 89.1 79.8
SD 13.7 13.9 14.7 14.8
Baseline Height (cm)
Mean 169.5 169.1 161.9 166.9
SD 5.7 5.7 10.1 7.8
BMI (kg/m2)
Mean 25.3 27.4 34.0 28.9
SD 4.2 6.3 4.6 6.1
Screening xerostomia assessment—difficulty swallowing (0–10)
Mean 0.0 0.0 0.0 0.0
SD 0.0 0.0 0.0 0.0
Screening xerostomia assessment—dryness of lips(0–10)
Mean 0.4 1.6 0.2 0.7
SD 0.5 2.1 0.4 1.3
Screening xerostomia assessment—dryness of tongue (0–10)
Mean 0.0 0.0 0.0 0.0
SD 0.0 0.0 0.0 0.0

BMI, body mass index; SD, standard deviation

Note: Dosing sequence A: Period 1, low-dose sublingual; Period 2, high-dose sublingual; Period 3, intravenous. Dosing sequence B: Period 1, high-dose sublingual; Period 2, intravenous; Period 3, low-dose sublingual. Dosing sequence C: Period 1, intravenous; Period 2, low-dose sublingual; Period 3, high-dose sublingual

Note: Percentages were based on the number of subjects (N) in the dosing sequence. Body mass index was calculated as weight (kg)/[height (m)2]

Note: Xerostomia scores were subject reported and based on a scale of 0 to 10, with 0 being not difficult/dry at all and 10 being very difficult/dry