• Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\]), if applicable)

• Infant gestational age ≥ 37 completed weeks

• Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg

• Singleton birth

• Infant age ≤ 8 months

• Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk

• Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:

‣ Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria/angioedema or vomiting, bloody streaks in stool, or respiratory symptoms

⁃ For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present

• Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study

• Infant's parent(s)/LAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol