Fig. 2.

Patient disposition. ^aThe safety population comprised all enrolled participants who received at least one dose of LDX during the study. ^bThe FAS comprised all participants who received one dose of LDX and had at least one on-treatment post-baseline efficacy assessment; all 14 participants from a single study site were excluded from the efficacy analyses because of a serious violation of Good Clinical Practice. ^cThe number of participants refers to individuals in the enrolled population who completed the study. A total of 191 participants who were included in the FAS completed the study. ^dAccording to the protocol, lack of efficacy (in the opinion of the investigator) was to be reported as an adverse event. Five additional patients discontinued because of investigator-perceived lack of efficacy; according to the protocol, these should have been recorded as treatment-emergent adverse events. FAS full analysis set, LDX lisdexamfetamine dimesylate