Table 1.

Study time points

Study period
Stages ➔	Enrolment	Pre-allocation	Allocation	Post-allocation			Follow-up
Weeks	W0	W0	W0	W1	W2	W3	W15
Time points	T0			T1			T2
Eligibility Screening	X
Informed Consent	X
Allocation			X
Treatment				X	X
Assessments		X				X	X