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Table 2 Schedule of enrolment, interventions and assessments

From: Apremilast for genital erosive lichen planus in women (the AP-GELP Study): study protocol for a randomised placebo-controlled clinical trial

Procedure

Participant contact

Screening

Baseline inclusion

Visit 2

Telephone interview

Telephone interview

Visit 3

Telephone interview

End of treatment visit

Withdrawal visit

Week ± 7 days

Max − 90 days

0

4

8

12

16

20

24

Max 14 days after

Informed consent

x

        

Eligibility assessment

x

        

Randomisation

 

x

       

Study treatment

 

x

x

x

x

x

x

x

 

Compliance

  

x

x

x

x

x

x

x

Medical history

x

x

x

  

x

 

x

x

Safety evaluation

x

x

x

x

x

x

x

x

x

Clinical examination

x

x

x

  

x

 

x

x

Weight

x

x

x

  

x

 

x

x

PGA

 

x

   

x

 

x

x

PtGA

 

x

   

x

 

x

x

DLQI

 

x

   

x

 

x

x

FSDS-R

 

x

   

x

 

x

x

GHQ-28

x

x

x

  

x

 

x

x

GELP score

x

x

x

  

x

 

x

x

Vulval/vaginal biopsy

 

x

     

x

 

HCG1

x

x

x

x

x

x

x

x

x

GFR1

x

        

IGRA1

x

        

Collect patient diary

     

x

 

x

 

Clinical photo

 

x

     

x

 
  1. 1Blood or urine (HCG) sample