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Table 2 Details of study flow

From: Study of montelukast in children with sickle cell disease (SMILES): a study protocol for a randomised controlled trial

Procedures

Recruitment VA/B

Baseline V1 (week 0)

Phone call (week 2)

Phone call (week 6)

Follow-up V2 (week 12)

Phone call (week 14)

Informed consent

X

     

Recent labs

X

     

Medical history

X

     

Eligibility assessment

X

     

Demographics

 

X

    

Family functioning questionnaires

 

X

    

Concomitant medications

 

X

  

X

 

Questionnaires

 

X

  

X

 

Cognitive testing

 

X

  

X

 

MRI if consenting and feasible

 

(X)

  

(X)

 

Home oximetry if consenting and feasible

 

(X)

  

(X)

 

Randomisation

 

X

    

Dispensing of trial drugs

 

X

    

Drug accountability

    

X

 

Adverse event assessments

  

X

X

X

X