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. 2023 Aug 16;33(6):232–242. doi: 10.1089/cap.2022.0097

Table 3.

Summary of Dosing and Up-Titration Schedules for Cohorts 1 to 4 (Pediatric Participants with Autism Spectrum Disorder)

Intervention/postintervention day 10–17 years
5–9 years
Cohort 1
Cohort 2
Cohort 3
Cohort 4
10–12 years, 0.75 mg/day
13–17 years, 1.5 mg/day
10–12 years, 1.5 mg/day
13–17 years, 3.0 mg/day
0.5 mg/day
1.5 mg/day
N = 6 N = 6 N = 6 N = 6
Day 1, mg (mL) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1)
Day 2, mg (mL) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1)
Day 3, mg (mL) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1) 0.5 (1)
Day 4, mg (mL) 0.75 (1.5) 1.5 (3) 1.5 (3) 1.5 (3) 0.5 (1) 1.5 (3)
Day 5, mg (mL) 0.75 (1.5) 1.5 (3) 1.5 (3) 1.5 (3) 0.5 (1) 1.5 (3)
Day 6, mg (mL) 0.75 (1.5) 1.5 (3) 1.5 (3) 1.5 (3) 0.5 (1) 1.5 (3)
Days 7–42 0.75 (1.5) 1.5 (3) 1.5 (3) 3.0 (6) 0.5 (1) 1.5 (3)
Days 43–84 PK follow-up PK follow-up PK follow-up PK follow-up PK follow-up PK follow-up

PK, pharmacokinetics.