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Table 4 Study procedures

From: Stop of proton-pump inhibitor treatment in patients with liver cirrhosis (STOPPIT): study protocol for a prospective, multicentre, controlled, randomized, double-blind trial

Procedure

Screening

Baseline visit

Visits 2–6

Telephone interviews

Informed consent

X

   

In-/exclusion criteria

X

   

Randomization

 

X

  

Medical history/demographics

X

X

  

Adverse events/concomitant medication/endpoint assessment

 

X

X

X

Physical examination/height and weight

 

X

X

 

Vital sign assessment

X

X

X

 

Laboratory (haematology, biochemistry)

 

X

X

 

Pregnancy test

X

   

Stool samples & biobanking

 

X

X (visit 3)

 

Ultrasound

 

X

X (visit 4, 6)

 

Distribution and/or return of study medication and patients diaries

 

X

X

 
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Trials

ISSN: 1745-6215