Samples were divided between 2 groups for each dose: Group A at baseline, 2, 8, 18 hours; Group B at baseline, 1, 4, 12 hours to reduce the number of blood draws per infant. The variance of oral bioavailability was assessed to determine if further PK assessment was appropriate. It would be considered highly variable if the square root of the sum of the standard deviation squares of the area under the concentration-time curves from time zero to the time of the last quantifiable concentration (AUCT) for group A and Group B divided by the sum of the mean AUCT for group A and Group B was >1.2.

Single dose PK Valid-For Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and taken the test article on the date the PK samples were taken). 2 poor metabolizers were excluded from this analysis.

AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption. AUC was estimated from population pharmacokinetic (PK) modeling.

Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling.

Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.

Half life is the time required for half the quantity of absorbed drug to be metabolized or eliminated by normal biological processes. Half life was estimated from population pharmacokinetic (PK) modeling.

Single dose PK Valid-For-Efficacy patients (defined as those without any major protocol violations who completed the single-dose PK determinations and took the test article on the date the PK samples were taken) who also had measurable concentrations over the period of observation. 2 poor metabolizers were excluded from this analysis.