STEM-PD Open Label Extension (OLE)
STEM-PD Open Label Extension (OLE)
This study seeks to establish the safety and efficacy of extended twice daily treatments for
 treating symptoms associated with PD. Only participants who completed the STEM-PD RCT trial
 are eligible for the OLE.
Up to 220 participants will enter an open label extension (OLE) study during which all study
 participants will receive treatment for 12 weeks (84 days). Study participants will be
 followed for 16 weeks (112 days) post treatment-cessation and then the twice daily treatments
 will be re-introduced for the final 8 weeks (56 days).
Inclusion Criteria:

 -  Completion of the study activities in the STEM-PD RCT trial. l.

 -  Participants must be willing and able to give consent to participate in the study
 trial.

 Exclusion Criteria:

 -  Participant anticipates being unable to attend all visits and complete all study
 activities in both the RCT and OLE study trial.

 -  Women of child-bearing potential who are pregnant or plan to become pregnant during
 the course of the RCT or OLE study trial.