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Table 3 Visit schedule

From: Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II superiority clinical trial

 

Selection visit

(from − 3 months to day 0)

Baseline visit

(day 0)

Treatment visit

(day 7 ± 2)

Treatment visit

(day 15 ± 3)

Treatment visit

(day 28 ± 4)

End of treatment visit

(day 60 ± 7)

Side effect visit

(not scheduled)

Follow-up visit

(months 4, 6, and 8)

Final visit

(month 12)

Informed consent

x

        

Demographic data

x

        

Pathological background

x

        

Toxic habits

x

        

Chagas disease history

x

        

Concomitant medication

x

x

x

x

x

x

x

x

x

Directed anamnesis

x

x

x

x

x

x

x

x

x

Physical examination

x

x

x

x

x

x

x

x

x

Pregnancy test

 

x

       

Hematology

x

 

x

x

x

x

x

  

Biochemistry

x

 

x

x

x

x

x

  

HLA

x

        

Chest x-ray

x

        

EKG

x

        

PK

   

x

 

x

x

  

Serology

x

       

x

PCR

x

 

x

x

x

x

 

x

x

Other complementary tests

x

        

Adverse events

 

x

x

x

x

x

x

  

Randomization

x

        

Study medication

 

x

x

x

x

x

   
  1. Abbreviations: EKG Electrocardiogram, HLA Human leukocyte antigen, PCR Polymerase chain reaction, PK Pharmacokinetics
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ISSN: 1745-6215