Protocol CVT-301-005, Version 1.0 was never activated nor implemented at any study sites in the US or outside of the US except for Spain and the UK. Protocol CVT-301-005, Version 2.0 was submitted to the US Food and Drug Administration (FDA) and to Health Authorities outside of the US and was implemented at all study sites. Protocol Version 2.0 incorporated changes that clarified spirometry inclusion criteria, excluded patients treated with an investigational drug within 4 weeks or 5 half-lives before Screening, and removed the requirement that the onset time of dyskinesia be recorded during the 60-minute post-dose period. Protocol Version 2.1 reflected the local regulatory requirements in Belgium and Germany to include more stringent pregnancy contraception inclusion criteria and to require at-home monthly pregnancy tests for women of childbearing age in the CVT-301 treatment group. Protocol CVT-301-005, Version 3.0 was submitted to the US FDA and to Health Authorities outside of the US and was implemented at all study sites. Protocol Version 3.0 and Version 3.1 incorporated changes to allow an unscheduled visit to occur between SV1 and SV2 for the purpose of repeating concordance testing, the reordering of secondary and exploratory endpoints, and administrative clarifications. Additional changes, including those made to the inclusion and exclusion criteria, are documented in the summary of changes in Protocol CVT-301-005, Version 4.0 was submitted to the US FDA but not to Health Authorities outside of the US and was not implemented at any study sites because enrollment of additional patients was deemed unnecessary. A summary of the protocols and protocol amendments that were implemented at sites in the US, 11 countries in Europe (Austria, Belgium, Czech Republic, France, Germany, Hungary, Poland, Romania, Serbia, Spain, and the UK), and Israel. Only the protocols and protocol amendments (including summaries of changes between protocol versions that were