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Table 3 Study schedule

From: The facial nerve palsy and cortisone evaluation (FACE) study in children: protocol for a randomized, placebo-controlled, multicenter trial, in a Borrelia burgdorferi endemic area

 

Baseline/Inclusion

Telephone call 1 week

± 3 days

Telephone call 2 weeks

± 3 days

Visit 1 month

± 5 days

Visit 12 months

± 2 weeks

Written informed consent

X

    

Inclusion /Exclusion criteria

X

    

Allocation of code number

X

    

Medical history

X

    

Demographics

X

    

Weight/length/BMI

X

    

Physical examination

X

    

NeBoP score

X

    

House-Brackmann grading scale (HBGS)

X

  

X

X

Sunnybrook grading system (SFGS)

X

  

X

X

Concomitant medication

X

  

X

X

Initiation of study treatment

X

    

Compliance with study drug

 

X

X

  

Reporting of Adverse Events (AE)

 

X

X

X

X

Return of bottles of study drug

   

X

 

Facial disability index (FDI)

   

X

X

Facial Clinimetric Evaluation (FaCE) Scale

   

X

X

Synkinesis Assessment Questionnaire (SAQ)

    

X