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Abstract Background/Objectives Breast milk contains lutein derived from the mother's diet. This carotenoid is currently not added to infant formula, which has a small and variable lutein content from innate ingredients. This study was conducted to compare the growth of infants fed lutein-fortified infant formula with that of infants fed infant formula without lutein fortification. Subjects/Methods This 16-week study was prospective, randomized, controlled, and double-blind with parallel groups of healthy term infants fed either control formula (Wyeth S-26 Gold, designated as Gold) or experimental formula (Wyeth S-26 Gold fortified with lutein at 200 mcg/l, designated as Gold + Lutein). Two hundred thirty-two (232) infants ≤ 14 days postnatal age were randomized and 220 (94.8%) completed the study. Weight (g), head circumference (cm), and length (cm) were measured at Weeks 4, 8, 12, and 16. The primary endpoint was weight gain (g/day) from baseline to Week 16. Safety was assessed through monitoring of study events (SEs) throughout the study and evaluation of selected blood chemistry tests performed at Week 16. Results Infants in both treatment groups demonstrated appropriate growth. No differences between treatment groups were found in any of the measures of growth at any of the measurement time points. Both study formulas were well tolerated. The mean values of all measured blood chemistry parameters fell within the modified normal ranges for infants, and the values for both groups for any measured parameter were similar. Conclusions Infants fed lutein-fortified S-26 Gold demonstrated growth equivalent to that of infants fed unfortified lutein formula.

Interactions of the mortality models with HCQ efficacy were optimized in a cohort of 49 patients (10.2% of total RCT), with placebo 28-day mortality 46% and HCQ mortality 24% (p=0.1085). Interactions of placebo and HCQ survival models with 28-day mortality HCQ treatment effects determined optimum cutoffs, incrementally excluding from efficacy analysis patients predicted as HCQ non-responders. B Introduction: b Hydroxychloroquine (HCQ) was hoped to be repurposed for treating COVID-19, especially in regions where more expensive regimens were not available. [Extracted from the article]

The maximum modulus test(RE) for simultaneously comparing the means of normal distributions to a known constant is usually presented with the assumption of equal variances. A competing procedure(RI) for use when the unknown variances are not assumed to be equal is presented. Results of simulations are presented to examine various aspects of these procedures, such as comparisons of overall type I error rate and power when the variances are equal and consequences of using RE when the variances are not equal. Both procedures control the overall type I error rate if the variances are equal; however, if the variances are not equal, RI controls the overall type I error rate, but P(type I error) > α using RE for a nominalα-level test. If the variances are equal, the power is higher for RE, but the differences are usually small. If the variances are not equal, the power is usually higher for RE than for RI, but this is associated with the inflated type I error rate. Thus, it is recommended that RI be routinely preferred over RE. [ABSTRACT FROM AUTHOR]