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Article History

Received: 25 March 2022

Accepted: 21 November 2022

First Online: 14 December 2022

Declarations

:

: This study was conducted in accordance with the World Medical Association Declaration of Helsinki. The study was approved by the ethical committees of Ain Shams University (REF: FWA 00017585 / FMASU P93/2018), Cairo University (REF: N-106–2018), Alexandria University (IRB #: 0000–7555), Zagazig University (IRB #: 4872), Tanta University (REF: 32541/09/18) and Assiut University (IRB #: 17400010) all in Egypt; the Children Hospital Lahore (IERB #: 02/2019), the National Bioethics Committee Pakistan (REF: No.4–87/NBC-385/19/924), the National Institute of Child Health (IERB #: 02/2019), Rawalpindi Medical University (REF#: R-12/RM-1) and the Pakistan Institute of Medical Sciences, Children Hospital (REF #: 390) all in Pakistan; St. Luke’s Medical Center College of Medicine (REF: RP 18–12) in the Philippines; Gadjah Mada University (REF: KE/FK/0480/EC/2018) in Indonesia; University of Malaya (REF: MREC ID NO: 201892–6636) and the Ministry of Health Malaysia (REF: KKM/NIHSEC/P18-1756) in Malaysia; the Dr L H Hiranandani Hospital (REF: IECM/Res./October-2018/0001), the Institute of Child Health (REF: IEC/168/2018) and the Apollo Hospital (REF: IEC-CS App. No.: ACH-005/08–18) all in India. Parents or legally authorized representatives of all infants in this study provided written informed consent prior to enrollment.

: Not applicable.

: LL, NS, CIC, DE and IJ are or were current employees of Société des Produits Nestlé S.A., Vevey, Switzerland. YV has participated as a clinical investigator, and/or advisory board member, and/or consultant, and/or speaker for Abbott Nutrition, Ausnutria, Biogaia, By Heart, CHR Hansen, Danone, ELSE Nutrition, Friesland Campina, Nestle Health Science, Nestle Nutrition Institute, Nutricia, Mead Johnson Nutrition, Pileje, United Pharmaceuticals (Novalac), Yakult, Wyeth.