| Interventions/Assessment domains | Tests/Evaluations | Screening | Baseline & treatment start | Active treatment phase | Treatment-free follow-up period |
---|---|---|---|---|---|---|
 |  |  |  | Week 1 | (Week 2-8) | (Week 9-14) |
Treatment | Investigational drug | EPO (40,000 IU)/Placebo | - | 1× | 7× (weekly) | - |
Efficacy | Neurocognitive functions | Neuropsychological testing (120 min) | - | 1× | - | 2× (week 9,14) |
 |  | MRI, fMRI and cognitive tests | 1× | - | - | 1× (week 14) |
 | Psychopathology | Clinical Rating | - | 1× | 1× (week 5) | 2× (week 9,14) |
 |  | Questionnaires | - | 1× | 1× (week 5) | 2× (week 9,14) |
 | Quality of life questionnaires |  | - | 1× | 1× (week 5) | 2× (week 9,14) |
 | DXA scan |  | - | 1× | - | 1× (week 9) |
Safety | Physical exam |  | 1× | 1× | 7× (weekly) | 3× (week 9,10,14) |
 | Vital signs |  | 1× | 1× | 7× (weekly) | 3× (week 9,10,14) |
 | Urine pregnancy test |  | 1× | 1× | 3× (week 3,5,7) | - |
 | ECG |  | 1× | - | 2× (week 3,5) | - |
 | Adverse event monitoring |  | - | Continuously until week 10 | ||
 | Blood analysis | Haematology | 1× | 1× | 7× (weekly) | 3× (week 9,10,14) |
 |  | Blood chemistry | 1× | 1× | 7× (weekly) | 3× (week 9,10,14) |
 |  | BDNF, inflammatory and metabolic markers | - | 1× | 1× (week 5) | 2× (week 9,14) |