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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