Table 1.

Schedule for enrolment, interventions, and assessments.

	Study period
	Enrolment	Allocation	Post-allocation				Closeout
Timepoints	–t1	t0	t1	t2	t3	etc.	tx
Enrolment
Eligibility screen	x
Informed consent	x
Allocation		x
Interventions
Intervention group			x	x	x	x
Control group			x	x	x	x
Assessments
Baseline measures:	x
Socio-demographic/Medical data	x
VAS	x
HADS
Outcome measures
VAS			x	x	x	x	x
HADS					x		x
Vital signs			x	x	x	x	x
Medication usage			x	x	x	x	x