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The upper limit for 2nd stage (when total inclusion is completed) rejecting of the drug due to inadequate response is ≤ 32 patients without being progression free at 4 months.
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We also obtained sick leave data from the Norwegian Labor and Welfare Service (Ny arbeids- og velferdsforvaltning, NAV) from the start of the study until 6 months after inclusion was completed.
The randomization code will not be revealed until participant inclusion is complete.
The inclusion is complete as off the end of 2007 with follow-up measurements going on until at least the end of 2009.
Follow-up within 28 days after inclusion was complete both for the primary endpoint (weaning from ventilator-demanding respiratory) and for mortality in both cohorts.
The "inclusion form" is completed directly with the medical practitioner during the outpatient/inpatient consultation.
To facilitate schedule of the telephone interview and the collection of study data during the telephone interview, the patient has to complete two additional forms: The "inclusion form" is completed directly with the medical practitioner during the outpatient/inpatient consultation.
The inclusion interview and completion of questionnaires is completed before the randomisation without either patient or study mangers knowledge of group allocation.
Patient accrual is completed with inclusion of the last patient and should extend for approximately 4 years from trial initiation.
At the end of the inclusion visit, an inclusion form was completed by the physician.
Follow-up assessment was performed 3 months after inclusion and was completed on 29 March 2012.
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