Schedules of study procedures
| Procedure | Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 |
| Time window, days | Day −14 to −1 | Day 1 | Day 30±7 | Day 90±14 | Day 180±14 | Day 270±30 |
| Informed consent form | X* | |||||
| Inclusion/exclusion criteria assessment | Х | |||||
| Medical history | X | Х† | ||||
| Prior/concomitant medication review | X | Х† | X | X | X | X |
| Pregnancy test | X | X | ||||
| Demographic data (age, race) | Х | |||||
| Height, weight, BMI calculation‡ | X | |||||
| Collection of baseline characteristics (including social information) | X | |||||
| Date/time of TBI and injury characteristics including worst recorded GCS score | Х | |||||
| Cognitive Failures Questionnaire (CFQ) | X | |||||
| Randomisation | X§ | |||||
| CNS-Vital Signs (cognitive assessment) | Х | Х | Х | Х | Х | |
| Quality of life assessment (QOLIBRI) | X | X | X | X | X | |
| Mood assessment (HADS) | X | X | X | X | X | |
| Postconcussion symptoms (RPQ) | X | X | X | X | X | |
| Physical examination | Х | Х | X | X | X | X |
| 12-Lead ECG | X | X | ||||
| Vital signs | X | X | X | X | X | X |
| Clinical laboratory tests (Haematology, blood chemistry, urine) | X | X | ||||
| Compliance assessment | X | X | X | X | ||
| Adverse event monitoring | X | X | X | X | X | |
| Investigational product supply | X | X | X | |||
| Study drug administration | Day 1–Day 180±14 days | |||||
*Informed consent form must be obtained prior to performing any study-related procedures.
†Not necessary if complete information was obtained on screening.
‡Body weight and height will be obtained without outerwear and shoes; BMI=weight (kg)/height (m2).
§Subjects will be randomised just prior to dosing. Further drug intake will be done according to the randomisation scheme.
BMI, body mass index; GCS, Glasgow Coma Score; HADS, Hospital Anxiety and Depression Scale; RPQ, Rivermead Post Concussion Symptoms Questionnaire; TBI, traumatic brain injury.