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Premature study withdrawal is considered if requested by the patient or next of kin.
The predominant reasons for premature study discontinuation were adverse events (n = 6) in the indomethacin group, and withdrawal of consent (n = 2) in the placebo group.
In addition, all adverse events necessitating a physician's visit or leading to premature study discontinuation, and all serious adverse events were recorded during the 6-month follow-up periods after the second and booster vaccinations.
Adverse events led to premature study discontinuation for two valsartan-treated patients (hypotension, mesothelioma).
This resulted in premature study closure in some of these trials.
Frequency of premature study drug discontinuation was LCPT: 12% versus tacrolimus twice daily: 5% (p = 0.028).
Similar(32)
We defined premature death as death before the age of 55 years, following criteria used in previous studies on premature death.
In preclinical studies, premature responding is studied with the 5-choice serial reaction time task (5-CSRTT), a test for visual attention in which rodents monitor and respond to unpredictable visual targets (1).
In patients with a diagnosis of threatened premature labour, studies have shown that PIBF levels failed to increase during pregnancy.
All ICU patients discharged alive to the ward during 1997-1999, whose reason for discharge had been recorded by the ICU consultant as fully fit or premature were studied.
Rates of premature discontinuation of study drug or study withdrawal because of any adverse event were similar for both study drugs.
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