Table 1.

Study timeline

Year 1
Task	M1	M2	M3	M4	M5	M6	M7	M8	M9	M10	M11	M12
Finalise protocol, IRB, training, DSMB			XX	XX	XX
Participant recruitment (n=500)					XX	XX	XX	XX	XX	XX	XX	XX
Participant follow-up					XX	XX	XX	XX	XX	XX	XX	XX
Progress report, DSMB												XX
Year 2
Participant recruitment (n=500)	XX	XX	XX	XX	XX	XX	XX	XX	XX	XX	XX	XX
Participant follow-up	XX	XX	XX	XX	XX	XX	XX	XX	XX	XX	XX	XX
Progress report, DSMB												XX
Year 3
Participant follow-up	XX	XX	XX
Data analysis				XX	XX	XX	XX	XX
DSMB				XX
Progress/final report									XX	XX	XX	XX

DSMB, Data and Safety Monitoring Board; IRB, Institutional Review Board.