Methods
ADHD
This was a DO, open-label safety study with SDX/d-MPH administered orally in children aged 6–12 years with ADHD (NCT03460652). The study was conducted at 18 sites in the United States. The study protocol and amendments were approved by an institutional review board before each center's study initiation. Written informed consent was obtained from all subjects before enrollment in the study. The first subject was screened on February 21, 2018, and the last follow-up visit was on June 27, 2019. This study included new subjects and those who completed the pivotal DB, placebo-controlled laboratory classroom study and were rolled over into the current study (rollover subjects).