Kim Annink

201 Pharmacokinetics of allopurinol in the ALBINO trial ≥10.8 points, corresponding to a p-value of <0.001, was considered statistically significant (χ 2 -distribution with 1 degree of freedom (df)). Individual PK parameter estimates were obtained as MAP Bayesian estimates using the POSTHOC option of NONMEM. From these estimates the total exposure expressed as AUC value were calculated. The analytical and modelling facilities will be unblinded to treatment allocation (after signing an appropriate confidentiality agreement), while maintaining blinding of treatment allocation in all clinical centers. The analytical and modelling facilities are not otherwise involved in the ALBINO. RESULTS In total, 15 patients received allopurinol, 9 of them were treated with hypothermia. The mean number of samples per patient was 5. Plasma concentrations of allopurinol varied between 0.706 mg/L and 24.4 mg/L, and 10 (14.7%) samples were below LLOQ. Oxypurinol concentrations ranged from 0.146 mg/L to 8.84 mg/L, and 4 (5.9%) samples were below LLOQ. See Table 2 for baseline characteristics. Table 2: Baseline characteristics Characteristic Therapeutic hypothermia (n=9) No therapeutic hypothermia (n=6) Gestational age (weeks), median (IQR) 39 (2.0) 40 (1.5) Birth weight (gram), median (IQR) 3150 (690) 3760 (470) Male, n (%) 6 (66.7) 1 (16.7) Lactate level at 12 hours after birth, median (IQR) 16.4 (13.4) 2.8 (3.4) Thompson score at 2-6 h after birth (before start of therapeutic hypothermia if applicable), median (IQR) 9 (10.00) 5 (0.75) IQR = interquartile range 9