1. Assessed for eligibility (N = )
Excluded (n = )
Not meeting inclusion criteria (n = )
Refused to participate (n = )
Other reasons (n = )
Patients randomly assigned (n = )
Allocated to intervention (n = )
Received allocated intervention (n = )
Did not receive allocated intervention (n = )
Allocated to intervention (n = )
Received allocated intervention (n = )
Did not receive allocated intervention (n = )
Lost to follow-up (n = )
Discontinued intervention (n = )
Lost to follow-up (n = )
Discontinued intervention (n = )
Analyzed (n = )
Excluded from analysis (n = )
Analyzed (n = )
Excluded from analysis (n = )