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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.
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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.
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.
At the end of the inclusion visit, an inclusion form was completed by the physician.
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 assessment was performed 3 months after inclusion and was completed on 29 March 2012.
In the absence of exclusion criteria, the inclusion form was completed.
All the records at the A&E Department were reviewed 2 years after the inclusion of patients was completed.
At inclusion, catch-up growth was completed in SGA children and BMI or percent fat were similar to AGA children.
The inclusion of 491 persons was completed in November 2008.
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