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Table 2 Schedule of assessments

From: Dipeptidyl peptidase-4 inhibition and narrow-band ultraviolet-B light in psoriasis (DINUP): study protocol for a randomised controlled trial

 

Screening visit (week 3)

Baseline visit (day 0)

First treatment visit (week 3 ± 7 days)

Second treatment visit (week 6 ± 7 days)

Third treatment visit (week 12 ± 7 days)

Fourth treatment visit (week 24 ± 7 days)

First follow-up visit (week 30 ± 7 days))

End of study visit (week 36 ± 7 days)

Early withdrawal visit

Visit number

1

2

3

4

5

6

7

8

 

Informed consent

X

        

Inclusion/exclusion criteria

X

        

Demographic data

X

        

Medical history

X

        

Quality of life assessments

 

X

X

X

X

X

X

X

X

Concomitant medication

X

X

X

X

X

X

X

X

X

Height

 

X

       

Weight

X

X

X

X

X

X

X

X

X

Blood pressure and heart rate

X

X

X

X

X

X

X

X

X

PASI assessment

X

X

X

X

X

X

X

X

X

Blood samplesb

X

X

X

X

X

X

X

X

X

Urinary pregnancy test (women of child-bearing potential only)

X

X

     

X

X

Adverse event assessment

 

X

X

X

X

X

X

X

X

IMP dispensing (arm A)

 

X

       

IMP accountability return and compliance check

  

X

X

X

X

  

Xa

  1. aif applicable
  2. bsafety and efficacy variables
  3. IMP Investigational Medicinal Product, PASI Psorasis Area and Severity Index
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Trials

ISSN: 1745-6215