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The study followed RA patients who failed at least one disease-modifying antirheumatic drug (DMARD) who were enrolled in a prior phase I/II dose-ranging trial.
In a prior phase of research, we developed a conceptual framework of disability from the perspective of adults living with HIV.
There were no serious AEs associated with VM202 treatment either in this study or in a prior phase I/II of DPN, 33 and the plasmid was similarly well tolerated in a study of critical limb ischemia.
In a prior phase I trial, we established the neoadjuvant regimen of 3 weekly doses of CPT-11 with concomitant HART followed by immediate surgery (Voelter et al, 2003).
42 A similar regimen with capecitabine plus cyclophosphamide in combination with bevacizumab is now undergoing randomised phase III clinical trial evaluation because of the efficacy of this regimen as reported in a prior phase II clinical trial, 43 and because of its minimal associated toxicity, 43 and http://www.clinicaltrials.gov, NCT01131195.
In a prior phase I study, we prospectively evaluated the Chatelut formula, and reported that the predicted carboplatin clearance (CL) was closely correlated with the actual CL, and the actual AUCs of carboplatin nearly reached the target AUC of 5 (Fukuda et al, 1999).
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In the episodic task participants indicated the screen location where words had been shown in a prior study phase (left/right/new); whereas in the perceptual task they indicated the current screen location of the word (top/middle/bottom).
These were: (i) words encountered in a prior study phase (studied words), (ii) words presented at test for the first time (new words), and (iii) new words repeated after a lag of 7 9 intervening words (repeated test words).
In a prior randomised phase III study in this setting (EFECT) no significant difference was observed between fulvestrant and exemestane, with a median progression-free survival of only 3 months [ 2].
While cross-study comparison is complicated due to many variables, median PFS and OS in patients treated with pemetrexed/cisplatin alone in this study were longer than the 4.8 and 10.3 months, respectively, observed in a prior large phase III trial of pemetrexed/cisplatin in chemotherapy-naïve NSCLC patients [ 10].
In the prior phase II trial a high rate of grade III and IV nausea (38%) and vomiting (20%) was observed, probably due to the fact that 5-HT3 receptor blockers were rarely given throughout the study period [ 8].
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