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. 2021 Dec 6;11(12):e048290. doi: 10.1136/bmjopen-2020-048290

Table 1.

Inclusion and exclusion criteria of the Toddler Milk Intervention trial

Inclusion criteria Exclusion criteria
Legal guardians signed the written informed consent. Infant who is breastfed at least twice in 24 hours at time of enrolment.
Child was born full term (≥37 + 0 weeks of gestation). Infant who usually does not drink 300 mL of cow’s milk and/or formula milk per day.
Child’s birth weight is between 2.5 and 4.5 kg. Cow’s milk allergy.
Child is born from a singleton pregnancy. Lactose intolerance.
Child’s age at enrolment is between 11.5 and 13.5 months. Institutionalised children.
Child’s legal guardians are of legal age and they have sufficient local language skills to understand the study information, informed consent and study procedure. Diagnosed disorder, which interfere with nutrition or growth (eg, coeliac disease, inflammatory bowel disease).
Child and child’s parents are willing to fulfil the requirements of the study protocol and procedures. Children who participated in any other interventional clinical trial 4 weeks prior to enrolment.
Child’s family is available via phone or e-mail throughout the whole study.