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In a milestone trial (NSABP B31), asymptomatic decrease in LVEF occurred in 14% of patients, requiring discontinuation of trastuzumab [ 13].
Over the past decade, Chinese investigators have completed several phase 3 trials [ 5– 8] that have greatly changed the clinical practice of treating lung cancer [ 9], including the Iressa Pan-Asia Study (IPASS), which was a milestone trial [ 5].
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However, since the milestone trial by the group of Vicenza in 2000 [ 41], a dose of 35 mL/kg per hour has been widely used, with a trend to increased doses in patients with sepsis [ 42].
Further studies are needed to analyse in detail the impact of "milestone" trials and related drug regulatory actions on real-life prescription behaviour.
In addition to milestone trials [ 2- 4], current published retrospective data from the large Finnish registry showed in a large group of patients a significant reduction of hospital mortality of survivors of out-of-hospital cardiac arrest after implementation of hypothermia [ 5].
The MOSAIC trial, a milestone publication [ 6], established the combination of 5-fluorouracil (5-FU), leucovorin and oxaliplatin (FOLFOX4) as the standard adjuvant chemotherapy regimen, replacing 5-FU and leucovorin in UICC-stage III colon cancer-patients after R0 resection [ 6, 7].
The trial is a milestone, legal experts said, in the legal battles lasting decades over sex abuse by priests.
Mr. Karadizic's trial is a milestone for Bosnia, and is an opportunity for the state to overcome its corrupt and bloody history and repair its image.
But while the trial was a milestone in civilian control over the military, it was lacking and flawed in other respects.
This week the supreme court voted to convict José Dirceu, Lula's chief of staff, as well as two other senior former PT men.In this section Stuck with him Caught napping Local action ReprintsMany Brazilians see the trial as a milestone in the strengthening of democratic institutions especially if the court jails Mr Dirceu.
The trial is a milestone for Armenia as it is reportedly the first time the country has convicted a computer criminal.
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