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Property:Results after intervention

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Baseline to week 104: Intervention arm sign. Reduction in NTX (more severe neuropathy) compared to placebo arm (mean difference -1.39 points, 95% CI = -2.48, -0.30; p=0.01); particularly strong at week 24 (end of intervention) (-1.68, 95% CI = -3.02, -0.33), week 36 (-1.37, 95% CI = -2.69, -0.04) and week 52 (-1.83, 95% CI = -3.35, -0.32), but no difference at week 104 At 104 weeks, 39.5% on the ALC arm and 34.4% on the placebo arm reported a five-point (10%) decrease from baseline; in both arms, 104-week NTX scores were statistically significantly different compared with baseline (p<0.001) Addition: Predictors: A 5-point reduction on the scale from baseline: Women aged ≥60 had an increased risk of worse neuropathy symptoms compared to those under 60 in year 1 (both arms). In arm A, weight was significantly associated with a 14% increased risk of worsening neuropathy for every 5 kg weight gain in year 1, and a 16% increased risk of worsening neuropathy per 5 kg weight in year 2. No further associations with baseline values were observed.  +
The univariate analysis according to treatment arm at 1 week after radiation showed placebo cream had an increased CSSP effect of 0.61 (p=0.0845) greater than that for powder. Also, aloe cream had an increased CSSP effect of 0.80 greater than that for powder (p=0.0283).  +
No statistically significant differences were found in the symptoms of dryness, itching, or burning among the 3 arms at 1 week after radiotherapy. A statistically significant difference was found in the pain scores, with 9 of the 67 powder arm patients rating pain as high compared with 21 of 72 in the aloe arm and 25 of the 74 in the placebo arm (p=0.0163).  +
No difference between the treatment arms was found among the arms in the Likert scales measuring the change in the symptoms comparedwith the previous week.  +
Overall: There was no difference between patients who received placebo or SRT501 in terms of plasma/serum levels of prostaglandin E2 (PGE-2) and vascular endothelial growth factor (VEGF). The analysed tissue samples show no significant differences between placebo and SRT501. Apoptosis, as reflected by immunohistochemistry for cleaved caspase 3 in tumor tissue, was significantly increased by 39% (to 1.44% total apoptotic cells, p=0.038) in patients on SRT501 compared to those taking placebo.  +
Overall: (1) Blood: Resveratrol concentrations were below the lower limits of quantitation (LLOQ) for all samples from subjects receiving placebo, and measurable in patients who received SRT501. Cmax levels were reached 2.8 h post-dose, and the mean maximum plasma concentration was 1942 ng/mL (8.51 nmol/mL). The mean plasma elimination half-life was just over 1h. (2) Tissue: Levels of resveratrol were below the LLOQ in all subjects on placebo and one of the six patients on SRT501. Mean resveratrol levels in the remaining five patients receiving SRT501 were 1098±1393 ng/g (4.81 nmol/g, range 52-2834 ng/g) and 420±341 ng/g (1.84 nmol/g, range 46-914 ng/g) in tumor and normal tissue, respectively.  +
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52 patients without vitamin D normalization from the control arm switched to the intervention arm after 6 months: at 12 months, 44% of these patients (n = 23) showed vitamin D normalization, median 6- and 12–month vitamin D levels were 23.9 ng/ml (8.1–29.6) and 28.6 ng/ml (16.3–53.0) respectively (p < 0.001)  +
Significant difference in mean serum selenium level between two arms at 14 days after transplantation (8.34 mcg/dL in the selenium arm vs 7.36 mcg/dL in the placebo arm), p=0.018  +
Overall: No difference between arms for increase in serum creatinine; p=0.31 or increase in aspartate aminotransferase and alanine transaminase: p=0.62  +