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Table 1 Treatment period and evaluation schedule

From: An open-label, multicenter study to evaluate the safe and effective use of the single-use autoinjector with an Avonex® prefilled syringe in multiple sclerosis subjects

  Screening visit Injection using the prefilled syringe Injections using the prefilled
pen
EOS or
EW
  Clinic Clinic Clinic Clinic Clinic Clinic Clinic Home Clinic Clinic
  14-day period Day 1 Day 2 Day 3 Day 8 Day 9 Day 10 Day 15 Day 22 Day 23
Treatment and evaluations   Injection 1    Injection 2    Injection 3 Injection 4  
Study enrollment   x         
Injection using the prefilled syringe   x         
Neopterin serum sample collection   xa xb xc xa xb xc    
Prefilled pen training      x      
Injection using the prefilled pen      x    x x  
Patient assessment of the prefilled pen training materials      x    x x  
Patient assessment of injection site pain   xd    xd    xd xd  
Patient assessment of ease of use   x    x    x x  
Patient assessment of injection procedure   x    x    x x  
Clinician assessment of injection site   xe x   xe x    xe x
Observation form          x  
Preference questionnaire           x
Patient assessment and dosing information forms dispensed      x      
Concomitant therapy and adverse events Monitor and record throughout study
  1. EOS, end of study; EW, early withdrawal.
  2. aNeopterin samples were to be obtained 1 hour pre-injection.
  3. bNeopterin serum samples were to be obtained 24 hours ± 2 hours post-injection.
  4. cNeopterin serum samples were to be obtained 48 hours ± 2 hours post-injection.
  5. dTo be completed within 1 hour before injection and also immediately after injection.
  6. eClinician injection site assessment was to be performed within 1 hour before injection.