Study design
The study design included a 30-day screening phase, a 3-week DO phase, a 360-day treatment phase, and a follow-up visit. Only new subjects underwent screening and DO. During the DO phase, new subjects were titrated to their optimized dose based on the best dose response and individual tolerability to the treatment (Childress et al. New subjects started treatment with the 39.2/7.8 mg dose of SDX/d-MPH daily, which is a molar equivalent to 30 mg of total d-MPH HCl, for 7 days. If needed, dose adjustments were performed based on the investigator's assessment of the subject at weekly intervals. The SDX/d-MPH dose could be increased to 52.3/10.4 mg (40 mg molar equivalent of total d-MPH HCl), decreased to 26.1/5.2 mg (20 mg molar equivalent of total d-MPH HCl), or maintained at the same dose for the next week of dosing.The dose at the end of the third week was assigned as the optimized dose. Subjects who rolled over from the pivotal study remained on their optimized dose from that study. The optimized SDX/d-MPH dose was used during the treatment phase. All subjects were administered 1 capsule daily of their optimized dose of SDX/d-MPH. Weight and height analyses were conducted in the treatment phase safety population of enrolled subjects. This population included those who received at least 1 dose of study medication and had at least 1 postdose safety assessment in the treatment phase. Completers are those subjects that completed 12 months of treatment.