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Table 2 Study visits

From: Treatment with PBI-4050 in patients with Alström syndrome: study protocol for a phase 2, single-Centre, single-arm, open-label trial

Visit

Screen

Wk 1

Wk 4

Wk 8

Wk 12

Wk 16

Wk 20

Wk 24

EP 12

EP 24

EP 36

EP 48

EoS

Informed consent

X

      

X

     

Demography and History

X

            

Physical examination

X

X

  

X

  

X

X

X

X

X

X

Vital signs

X

X

X

X

X

X

X

X

X

X

X

X

X

Weight & waist

X

X

X

X

X

X

X

X

X

X

X

X

X

Haematology/Biochemistry

X

X

X

X

X

X

X

X

X

X

X

X

X

Urinalysis

X

X

X

X

X

X

X

X

X

X

X

X

X

12-lead ECG

X

X

  

X

  

X

X

X

X

X

X

IMP accountability

 

X

X

X

X

X

X

X

X

X

X

X

 

Fasting glucose profile

 

X

X

X

X

X

X

X

X

X

X

X

X

Adverse events

 

X

X

X

X

X

X

X

X

X

X

X

X

Concomitant medications

 

X

X

X

X

X

X

X

X

X

X

X

X

FibroScan

 

X

  

X

  

X

X

X

X

X

 

Liver/Cardiac MRI

 

X

     

X

  

X

  

Insulin clamp/Microdialysis

 

X

     

X

     

Adipose tissue biopsy

 

X

     

X

     

Metabolic syndrome parameter

 

X

  

X

  

X

X

X

X

X

 

Biomarkers

 

X

X

X

X

X

X

X

X

X

X

X

 
  1. Screen Screening visit, Wk weeks, EP Extension phase visits