Table 3 Study visits and procedures

Time

0 weeks, baseline

2 weeks (± 5 days) after V1

3–6 months after V1 ± 14 days

Informed consent

x

Check eligibility

x

Randomization

x

Demographics/subject characteristics

x

x

Family characteristics

x

x

Medical history

x

x

Review adverse events (AEs)

x

x

Review concomitant medication

x

x

x

Nutritional characteristics

x

x

Physical examination

x

x

SCORAD, EASIscore (in case of eczema)

x

x

Transepidermal water loss measurement (TEWL)

x

x

Palmar hyperlinearity

X

Skin prick testing

(x)^a

x

Skin swabs

x

x

Saliva sampling

x

x

Stool sampling

x

x

Dust sampling

x

x

Blood sampling

(x)^a

x

Oral food challenge

x

Dispensation of the study product

x

Feeding of the study product at the site

x

Review tolerance study product

x

x