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To allow for early termination, the study was designed to be assessed in four equally spaced interim analyses and one final analysis.
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After termination of the study monitoring of outcome and complications of the hypothermia treatment will be continued using this database.
Table 1 lists the individual details, experimental outcome and pathological status of the pigs at the termination of the study.
At termination of the study, patients completed a global assessment scale.
At the termination of the study, at 18th week, the surplus rats were sacrificed by cervical decapitation.
At termination of the study at 10 months, mice exposed in utero also had greater lung tumor multiplicity than mice exposed only during lactation.
Two treatment-related deaths occurred following chemoradiation, prompting premature termination of the study.
When HFOV failure was ascertained, CMV was removed leading to the termination of the study and an alternative method of oxygenation (prone positioning or ECMO) was initiated.
Due to the higher number of subjects worsening on sildenafil, the data and safety monitoring board recommended early termination of the study.
Cardiac function was assessed by serial echocardiography in conscious mice, and the level of myocardial betaARKct protein was quantified at termination of the study.
Unfortunately, severe side effects occurred in two patients with this compound in the phase II trial, leading to termination of the study.
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