Procedures
PD
The study consisted of open-label dose-optimization and open-label treatment phases (Study design. SL-APO (Dose optimization of SC-APO (Initially, use of the antiemetic domperidone was optional if clinically warranted and was not to be used prophylactically. After a protocol amendment, domperidone use remained optional but could also be used prophylactically or if clinically warranted at the discretion of the investigator. If initiated, antiemetic therapy was discontinued when judged clinically appropriate.After a 3- to 7-day washout, patients entered the treatment phase and were randomized in a 1 : 1 ratio to 4 weeks of treatment with the optimized dose of SL-APO or SC-APO, followed by a washout and 4 weeks of crossover treatment. Patients continued their regular PD medication regimen and could self-administer study treatment for ≤5 OFF episodes per day when needed. Clinic visits occurred every 2 weeks, with the patient presenting in a practically defined OFF episode.