Institutional Review Board Statement
PSH
SECONDARY, DISEASE
This study was conducted at PennStateHealth (PSH) in compliance with the Declaration of Helsinki and guidelines for Good Clinical Practice issued by the International Conference on Harmonization. The protocol was reviewed and approved by the Institutional Review Board of the Penn State College of Medicine (protocol code 9437, approved 07/16/2018). The study’s IND was approved by the US Food and Drug Administration and registered in clinicaltrials.gov (PF 06412562 in Subjects With Advanced Stage Parkinson’s Disease), where the primary and secondary outcomes noted above were listed.