Table 1.

Schedule of enrolment, interventions and assessments

Time point		Enrolment	Allocation	Operation	Check-out
Enrolment	Eligibility screening	X
	Informed consent	X
	Allocation		X
Intervention	Test group			X
	Control group			X
Assessment	Laboratory tests	X		X	X
	Vital signs	X		X	X
	Primary efficacies			X
	Safety indicators			X