L-arginine and aged garlic extract for the prevention of migraine: a study protocol for a randomised, double-blind, placebo-controlled, phase-II trial (LARGE trial)

Table 2 LARGE trial schedule of assessments

	STUDY PERIOD
Visit	Screening /enrolment	Visit 1 (informed consent)		Visit 2		Visit 3 (EoS)
TIMEPOINT	-t₁ (1 day)	0 (1 day)	t₁ (2 weeks)	t₂ (1 day)	t₃ (12 weeks)	t₄ (1 day)
ENROLMENT:
Eligibility screen	X
Informed consent		X
Participant demographics		X
Participant anthropometric measures		X
Group allocation		X
INTERVENTIONS:
Placebo			X		X
L-arg					X
AGE					X
L-arg + AGE					X
ASSESSMENTS:
Daily and weekly migraine diaries			X		X
MSQ		X				X
SF-MPQ		X				X
L-VISS		X				X
VLSQ-8		X				X
OCTA				X		X
Acute light challenge				X		X
Blood markers				X		X

L-arg = l-arginine; AGE = aged garlic extract; t = timepoint; MSQ = Migraine-Specific Quality-of-life Questionnaire; SF-MPQ = Short-Form McGill Pain Questionnaire; L-VISS = Leiden Visual Sensitivity Scale; VLSQ-8 = Visual Light Sensitivity Questionnaire – 8; OCTA = optical coherence tomography angiography

ISSN: 1471-2377