This flow diagram summarizes the process of enrolling, allocating, and following participants in a clinical trial. It shows the number of participants assessed for eligibility, excluded based on inclusion criteria or declining participation. It then displays the number randomized into each study group, receiving the allocated intervention, lost to follow up, discontinuing the intervention, and finally analyzed.

1. CONSORT Flow Diagram
Enrollment Assessed for eligibility (n= )
Excluded (n= )
¨ Not meeting inclusion criteria (n= )
¨ Declined to participate (n= )
¨ Other reasons (n= )
Randomized (n= )
Allocation
Allocated to intervention (n= ) Allocated to intervention (n= )
¨ Received allocated intervention (n= ) ¨ Received allocated intervention (n= )
¨ Did not receive allocated intervention ¨ Did not receive allocated intervention
(give reasons) (n= ) (give reasons) (n= )
Follow-Up
Lost to follow-up (give reasons) (n= ) Lost to follow-up (give reasons) (n= )
Discontinued intervention (give Discontinued intervention (give
reasons) (n= ) reasons) (n= )
Analysis
Analysed (n= ) Analysed (n= )
¨ Excluded from analysis (give ¨ Excluded from analysis (give
reasons) (n= ) reasons) (n= )