Table 1 Overview on clinical assessments for each study visit
| time (months) | visit | clinical assessments |
|---|---|---|
| −3-0 | screening |
MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA informed consent check of inclusion/exclusion criteria |
| 0 | start visit |
MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA MRI/MRSI |
| 1 | phone call 1 | interview on AEs/SAEs, inquiry on self-ratings (diary cards) |
| 2 | phone call 2 | interview on AEs/SAEs, inquiry on self-ratings (diary cards) |
| 3 | visit 1 |
MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA |
| 4 | phone call 3 | interview on AEs/SAEs, inquiry on self-ratings (diary cards) |
| 5 | phone call 4 | interview on AEs/SAEs, inquiry on self-ratings (diary cards) |
| 6 | visit 2 (end of study treatment) |
MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA MRI/MRSI |
| 9 | follow-up visit |
MDS-UPDRS III Timed up and go test 10-m-walk test vital signs (safety) blood analyses MDS-UPDRS I, II, and IV PDQ39, BDI II, FSS, ESS, PDSS2, MoCA MRI/MRSI |