Analysis of All Patients Sample Clauses

Analysis of All Patients. ‌ The demographic characteristics of the 53 patients evaluated are presented in Table 6-1. At baseline, the definitive responders were prescribed more dietary phenylalanine, but similar amounts of medical food when compared to both the provisional and non- responder groups. Baseline plasma phenylalanine concentrations were lower in the definitive responders compared to the non-responders, and month one plasma phenylalanine concentrations segregated the non-responders from both the definitive and the provisional responder groups. A total of 705 days of diet records were collected, with a mean of 13.3 ± 2.8 days of diet records (range: 4-18 days) received from each participant. The mean number of diet record days collected during the first month did not differ between the BH4 response groups [F(2,49)=1.96, p=0.151]. Table 6-2 summarizes dietary intake and trends of all patients during the first month of BH4 therapy. The interaction term did not reached statistical significance in any of the models, thus identified changes in intake were collective rather than group-specific. There was an estimated 2.2 gram decrease in total protein intake from baseline to the month one study visit. This change appears to be primarily driven by a decrease in medical food intake, with a slight decrease in medical food prescription compliance emerging over time. Changes in reported intake of energy, phenylalanine, and phenylalanine prescription compliance over the course of the first month of BH4 therapy were not statistically significant. Typical intake of energy, total protein, and medical food along with medical food compliance during the first month of BH4 therapy did not differ between the three response groups. Typical phenylalanine intake, on the other hand, was significantly higher in the definitive responders compared to the provisional responders; the non- responders did not differ from either group. While the difference in typical dietary phenylalanine intake would be expected due to the greater baseline dietary phenylalanine prescription, it appears to be slightly exaggerated by greater prescription non-compliance in the definitive responder group. However, group differences in percent of phenylalanine prescription typically consumed did not reach statistical significance.
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