Received: 28 August 2019
Accepted: 27 April 2020
First Online: 14 May 2020
Ethics approval and consent to participate
: The study was approved by the BioMedical Research Institute of America, P.O. Box 600870, San Diego, CA 92160, on 12/8/16 (there is no approval number). All subjects or caregivers, where the participant was under 18 years of age, gave their verbal agreement after a detailed explanation of the objectives and necessary procedures for the study, and all subjects or their caregivers where the subject was under 18 years of age signed a written informed consent for the study, and minors signed an assent from, after being given adequate time to read these.
: There is no individual patient data so consent for publication was not requested.
: PES is a paid consultant for Spirosure Inc. and holds stock options in the company.MS is a paid contractor for Spirosure and provided the contract research organization (CRO) services to run the study.All the remaining authors are full-time employees of Spirosure and hold stock options in the company.