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Table 2 Time schedule of regular study visits

From: Trichuris suis ova in relapsing-remitting multiple sclerosis and clinically isolated syndrome (TRIOMS): study protocol for a randomized controlled trial

 

Screening

Random (month 0)

Tel.V1 -6 (week 0, 2, 4, 6, 8, 10, 16, 20, 28, 32, 40, 44) ± 3 days

V1 (month 3) ± 10 days

V2 (month 6) ± 10 days

V3 (month 9) ± 10 days

V4 (month 12) ± 10 days

V5 (month 15) ± 10 days (optional)

V6 (month 18) ± 10 days (optional)

Informed consent

x

        

In/exclusion criteria

x

x

       

Randomization

 

x

       

Demographic data

x

        

Pregnancy test

x

        

Confirmation of MS diagnosis

x

        

Relapse history

x

x

 

x

x

x

x

x

x

Medical history

x

x

 

x

x

x

x

x

x

Physical examination

x

  

x

x

x

x

 

x

Vital signs

x

x

 

x

x

x

x

 

x

Weight

x

     

x

 

x

MSFC

x

     

x

 

x

EDSS

x

 

x

x

x

x

x

 

x

Safety lab

x

  

x

x

x

x

 

x

Immunological sampling

 

x

 

x

x

x

x

 

x

MRI

x

   

x

x

x

optional

optional

AE/SAE

   

x

x

x

x

x

x

Questionnaires (fatigue, depression)

x

x

  

x

x

x

x

x

Drug supply

 

x

x

x

x

x

   

Drug account

    

x

 

x