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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