Table 2.

The schedule for enrollment, the interventions, and the assessments

Time points	T0a	Follow-ups for data on the key study variables and indicators						Follow-ups for anthropometric measurements	Study endpoint
		Days 1–13b	Days 14–25	Days 26–38	Days 39–44d	Days 45–52	Day 53-179	Day 27, 56, 85, 114, and 143
		Daily visitsc	48 hourly visits	72 hourly visits	Daily visits	72 hourly visits	Weekly	Monthly	Day 179
Enrollment
Eligibility assessment	Χ
Written informed consent	Χ
Randomization and allocation	Χ
Baseline data	Χ
Intervention
Nutrition and breastfeed counseling		Χ	Χ	Χ	Χ	Χ	Χ
BEP distribution and compliance assessmente		Χ	Χ	Χ	Χ	Χ	Χ
Oral azithromycin administration at day 42 and daily follow-ups for SAE monitoring after dose administrationf					Χ
Follow-ups
24-h breastfeeding recall		Χ	Χ	Χ	Χ	Χ	Χ
Infant assessment for danger signs		Χ	Χ	Χ	Χ	Χ	Χ
24-h maternal food intake recallg							Χ
Monthly maternal and infant anthropometry measurements performed by a separate team (blinded from intervention details)								Χ	Χ
Specimen collection at two time points only (mother and infants)h						X	X

^aWindow period for eligibility assessment and enrollment is 0–6 days of infant’s life

^bAge of the infant

^cFollow-up start day is depending on the age of the infant at the time of enrollment

^dPre- and post-azithromycin administration

^eOnly in the intervention arms 1 and 2

^fOnly in intervention arm 2 and window period of 7 days

^gOnly monthly basis

^hTwo time points only—first at day 41 and second at day 56 (window period of 7 days)