Table 2.

Time schedule of participant enrolment, interventions, assessments and visits

	Activity/assessment	Study period
		−1	0	T1	T2	T3
		Prestudy screening/consent (day −1)	Prestudy baseline/randomisation (day 0)	Study visit 1 (day 3)	Study visit 2 (day 7)	Study visit 3 (day 14)
Enrolment	Eligibility screen	X
	Informed consent	X
	Randomisation		X
	Characteristic		X
Intervention	Mupirocin plus aFGF		☆————————————☆
	Mupirocin plus placebo		★————————————★
Assessment	VAS for measuring nipple pain		X	X	X	X
	NTS		X	X	X	X
	MAPP-QOL		X	X	X	X
	Time to complete nipple pain relief			X	X	X
	Time to complete healing of nipple trauma			X	X	X
	Outcomes associated with the infant feeding			X	X	X
	Adverse events			X	X	X

☆Experimental group; ★ Control group.

aFGF, acidic fibroblast growth factor; MAPP-QOL, Maternal Postpartum Quality Of Life; NTS, Nipple Trauma Score; VAS, Visual Analogue Scale