Patientswere randomized (1:1) to fixed-dose cariprazine or placebo
for double-blind treatment of variable duration (26–72 weeks or until early termination including a relapse event) (Fig. 1). Per protocol, double-blind treatment for all active patients was stopped when the last
randomized patient completed 26 weeks of treatment regardless of
the number of relapse events. Investigators and patients were blinded to the double-blind treatment assignment through an interactive web response system; identically appearing treatments were used. Breaking the randomization code disqualified the patient from further participation.