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. 2020 Jul 29;9(7):e16162. doi: 10.2196/16162

Table 1.

Schedule of visits and assessments.

Assessment Screening visit: Day –28 to 0a Baseline visit: Day –7 to 0a Visit at 3 months Visit at 12 months Visit at 24 months Unscheduled visit (<10 days of relapse)
Informed consent Xb          
Inclusion and exclusion criteria check X X        
Demography Yc          
Medical history Y          
Height Y          
Weight Y

Y
 
Vital signs Y X Y Y Y  
Bristol Stool Scale
X X X X
Disease assessment: Expanded Disability Status Scale (EDSS) X
X X X X
Magnetic resonance imaging (MRI): brain Y      Y X  
Oral swab
X X X X
Stool sample collection for microbiota assessment   X X X X  
Blood sampling for immunological assessment   X X X X  
Concomitant medication Y
Y Y Y Y
Adverse events   Y Y Y Y Y
Food registration by patient   X X X X  

aScreening and baseline visit activities can be performed on the same day.

bX: study-specific assessment.

cY: routine assessment.