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1 t was preceded by a 30-day washout (modified intent-to-treat population).
2 ogical complete response (pCR; ypT0/is ypN0; intent-to-treat population).
3 zed: placebo, n = 360; lifitegrast, n = 358 (intent-to-treat population).
4 : 1.1% versus 1.8% with placebo (P=0.061 for intent-to-treat population).
5 Analyses were conducted in the intent-to-treat population.
6 d in analyses, and all analyses assessed the intent-to-treat population.
7 of median follow-up of 4,804 patients in the intent-to-treat population.
8 ree survival (PFS) in a biomarker-unselected intent-to-treat population.
9 the median follow-up was 11.6 months in the intent-to-treat population.
10 r PDA and SDA, respectively, in the modified intent-to-treat population.
11 duration of response, and biomarkers in the intent-to-treat population.
12 requiring treatment) through week 24 in the intent-to-treat population.
13 criteria for statistical significance in the intent-to-treat population.
14 egion, analyzed with a prespecified modified intent-to-treat population.
15 ry endpoint was disease-free survival in the intent-to-treat population.
16 al protocol, and data were obtained from the intent-to-treat population.
17 ry for the primary efficacy end point in the intent-to-treat population.
18 core for ADS-5102 vs placebo in the modified intent-to-treat population.
19 rmed using a stratified log-rank test in the intent-to-treat population.
20 model for repeated measures on the modified intent-to-treat population.
21 n the area of erythema at 48-72 hours in the intent-to-treat population.
22 Analysis was conducted with an intent-to-treat population.
23 Analysis was by intent-to-treat population.
24 ety population, and 307 were included in the intent-to-treat population.
25 Efficacy analyses were conducted in the intent-to-treat population.
26 ults reached trend-level significance in the intent-to-treat population.
27 overall survival (OS) were analyzed for the intent-to-treat population.
28 127 sham-treated subjects were in the year 1 intent-to-treat population.
29 The primary study comparison was done in the intent-to-treat population.
30 cy and safety analyses were performed on the intent-to-treat population.
31 complete response rate) was achieved in the intent-to-treat population.
32 e rate of 9.2% (10 partial responses) in the intent-to-treat population.
33 seline efficacy assessment and comprised the intent-to-treat population.
34 They comprised the intent-to-treat population.
35 were assessed in the completers and modified intent-to-treat populations.
36 nically meaningful improvement in median OS (intent-to-treat population: 13.1 months; subgroup with v
37 421 (93.3%) of 451 patients in the original intent-to-treat population (143 tacrolimus/basiliximab [
40 cebo were free of body lice on day 14 in the intent-to-treat population (28% vs 9%; P = .04), with a
41 up MIDAS scores and constituted the modified intent-to-treat population (35 control patients and 34 P
44 RD) negativity (10-5 threshold) rates in the intent-to-treat population (51.0% vs 20.4%; P < .0001).
46 for an objective response rate of 15% in the intent-to-treat population (95% confidence interval, 11%
48 la 2.5 versus 40.1% for IABP, P=0.227 in the intent-to-treat population and 34.3% versus 42.2%, P=0.0
49 ith IABP: 40.6% versus 49.3%, P=0.066 in the intent-to-treat population and 40.0% versus 51.0%, P=0.0
50 ing >=6 and >=12 months were analyzed in the intent-to-treat population and among patients achieving
51 he primary analysis was done in the modified intent-to-treat population and included all randomly ass
53 endpoints included event-free survival (EFS; intent-to-treat population) and safety (safety analysis
55 logical intent-to-treat population, clinical intent-to-treat population, and microbiological intent-t
56 symptom domain results were analysed in the intent-to-treat population, and PRO-CTCAE results were a
57 of this study was HIV seroconversion in the intent-to-treat population as estimated with Cox regress
58 groups on the modified Rankin scale for the intent-to-treat population at day 90 (mean difference, 0
60 ng the trial, and 755 comprised the modified intent-to-treat population (atogepant 30 mg twice a day
62 were no significant differences in OR in the intent-to-treat population between patients receiving ta
65 alyses were conducted in the microbiological intent-to-treat population, clinical intent-to-treat pop
72 180 randomly assigned patients comprised the intent-to-treat population evaluated for efficacy; 173 I
74 responses) after each treatment cycle in the intent-to-treat population every 4 weeks starting at wee
76 503 and 502 patients comprised the modified intent-to-treat population for oritavancin and vancomyci
78 Multivariable Cox regression analysis of the intent-to-treat population identify vaccine arm (12MP +
79 pulation and efficacy analyses in a modified intent-to-treat population (ie, excluding one person ass
80 oderate disease and severe disease (n = 183, intent-to-treat population), improvements in CAL and PD
82 eened, and 126 were randomized; the modified intent-to-treat population included 121 patients (51 wom
86 ry efficacy analyses were performed with the intent-to-treat population including all data through da
88 s were 71%, 74%, 77%, and 70%, respectively (intent-to-treat population, including protocol-defined p
90 opulation), 20 were included in the modified Intent-to-Treat population (mean age: 61.9 years; female
91 with PD 4 to 6 mm and > or = 7 mm (N = 209, intent-to-treat population), mean improvements in CAL an
100 all pathologic complete response rate in the intent-to-treat population (n = 80) was 36% (90% CI, 27
104 f twice-daily treatment with either placebo (intent to treat population, n = 130), 4 mg NM-702 (n = 1
111 eater than those for control subjects in the intent-to-treat population (P < 0.001 and P = 0.006, res
112 in favor of everolimus by 11.8 mL/min in the intent-to-treat population (P = 0.004) and 17.2 mL/min i
113 than 30% of hepatic reserve were randomized (intent-to-treat population: PDA, n = 31; SDA, n = 29), w
115 acy and safety were analysed in the modified intent-to-treat population (randomised patients who rece
117 d point was progression-free survival in the intent-to-treat population (significance threshold of .0
118 eplanned sensitivity analyses, including the intent-to-treat population, statistically favored pazopa
120 For treated patients across all cohorts (intent-to-treat population), the response rate was also
126 216 patients were randomized in the modified intent-to-treat population (Treatment, 102; Control 114)
127 d for each active dose level versus placebo (intent-to-treat population, two-sided alpha of .05).
128 rom start of therapy) in the microbiological intent-to-treat population using a NI margin of 12.5%.
131 Median progression-free survival in the intent-to-treat population was 7.1 months (95% CI, 5.9-8
133 rative re-evaluation of the underlying RCT's intent-to-treat population was performed for the entire
134 Invasive disease-free survival (IDFS) in the intent-to-treat population was statistically significant
141 er of discontinuations, the per-protocol and intent-to-treat populations were used for the primary ef
143 the two induction studies were based on the intent-to-treat population, which included all randomise
144 d points were also met, including PFS in the intent-to-treat population with an HR of 0.50 (95% CI, 0
146 ent-to-treat population, and microbiological intent-to-treat population with Pseudomonas aeruginosa a
147 ], although a sensitivity analysis, using an intent-to-treat population with the last CD4 cell count
148 ed twenty-nine patients were included in the intent-to-treat population, with 312 meeting all criteri
149 three patients were included in the modified intent-to-treat population, with 396 meeting all criteri