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Table 1 Study schedule

From: The TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis) trial: study protocol for a randomized, double-blind, placebo-controlled trial

 

Enrolment

Baseline

Treatment period

End of study

Day - 60

Day - 30

0

Week 6

Week 18

Week 30

Week 42

Week 54

Week 66

Informed consent

X

        

Eligibility screen

X

X

X

      

Tysabri® (routine care)

X

X

X

 

X

X

X

X

X

Clinical examination

X

 

X

X

X

X

X

X

X

Medical history

X

        

Prostate examination by a urologist

 

X

      

X

Prostate-specific antigen

 

X

 

X

 

X

  

X

Blood test (*fasting)

X

X

X*

X*

X*

X*

X*

X*

X*

Hormonal dosage

X

 

X

 

X

X

X

X

X

MRI

  

X

  

X

  

X

Nebido®/Placebo

  

X

X

X

X

X

X

X

Scales and cognitive tests

  

X

  

X

  

X

AE/concomitant treatments

X

X

X

X

X

X

X

X

X