Randomization
SECONDARY
Participants were randomized using a web-based randomization system and assigned a randomization number. A computer-generated randomization list was prepared by the Ottawa Methods Centre at the Ottawa Hospital Research Institute. Patients were randomized 2:1 using random variable block sizes (2–4 patients/block). A 2:1 randomization (high dose: placebo) schema was employed because the control group is not directly pertinent for our primary objective of dose evaluation but required to assess our secondary objectives. Randomization was stratified by patient age (above or below 30 days of age) and by site to account for site-specific practice variation. All study personnel, members of the health care team and patients/families were blinded to study group assignment. To help maintain blinding, the active drug and placebo were identical in appearance, consistency, volume, taste and smell. The randomization number was provided to the site pharmacist and matched to a hard-copy randomization list to determine treatment allocation. The hard-copy randomization list was only accessible to the Ottawa Methods Centre and to the site pharmacist.