Funding for this research was provided by:
Mead Johnson Nutrition (study sponsor)
Received: 11 August 2020
Accepted: 18 March 2021
First Online: 21 July 2021
: Parents or legally authorized representatives provided written informed consent prior to enrollment. The research protocol and informed consent forms observing the Declaration of Helsinki (including October 1996 amendment) were approved by: the University of Louisville Institutional Review Board (IRB; Louisville, KY); the University of Nebraska Medical Center IRB (Omaha, NE); Western IRB (Olympia, WA); and Schulman IRB (now known as Advarra, Columbia, MD). The study complied with good clinical practices.
: Not applicable.
: CBA, WHJ, HD, JL, RR and MY have received support for study site coordination and data collection from Mead Johnson Nutrition. CLH and JLW work in the Department of Medical Affairs and RH works in Nutrition Science at Mead Johnson Nutrition. TC was previously employed by Mead Johnson Nutrition.