Visit | –1, screening | 0, baseline | 1, start intervention | 2 | 3 | 4 | 5 |
---|---|---|---|---|---|---|---|
Month | −4 (max) | −1 | 0 | 3 | 9 | 15 | 18 |
Informed consent | x | ||||||
Demographics | x | ||||||
Inclusion/exclusion criteria | x | x | x | x | x | x | x |
Case history | x | ||||||
Medication | x | x | x | x | x | x | x |
Vital signs | x | x | x | x | x | ||
Bioelectrical impedance analysis | x | x | x | ||||
Anthropometric data | x | x | x | x | x | x | |
Hand grip strength | x | x | x | ||||
Safety laboratory | x | x | x | x | x | ||
Research laboratory | x | x | x | ||||
Urine sample | x | x | x | x | x | ||
Stool sample | x | x | x | ||||
Multiple Sclerosis Quality of Life-54 | x | x | x | ||||
Questionnaire on activities | x | x | x | ||||
Beck Depression Inventory II | x | x | x | ||||
Fatigue Severity Scale | x | x | x | ||||
Physical examination | x | x | x | ||||
Multiple Sclerosis Functional Composite | x | x | x | ||||
Symbol Digit Modalities Test | x | x | x | ||||
Six-minute walk test | x | x | x | ||||
Expanded Disability Status Scale | x | x | x | ||||
Relapse query | x | x | x | x | x | x | x |
AE/SAE query | x | x | x | x | x | x | |
MRI | x | x | x | ||||
Four-day food record | x | x | x | ||||
Nutritional counseling | x | * | * | * | * |