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The protocol should provide clear guidance about administration of study medication and other interventions.
We did not observe differences in how the patients were treated and followed up before and after the start of study medication in the recorded data.
RESULTS: A total of 1867 patients were randomized and received > or = 1 dose of study medication.
RESULTS: Eight subjects were enrolled, 7 of whom took at least 1 dose of study medication.
A total of 195 patients were randomized and received at least one dose of study medication.
A total of 197 patients were randomized and received at least one dose of study medication.
Each TTH attack was treated with a single dose of study medication.
A total of 63 patients met entry criteria and received a dose of study medication.
Earlier administration of study medication was associated with modestly better dyspnoea relief, but not 30-day clinical outcomes.
Tests were then repeated <10 days before and approximately 30 days after the discontinuation of study medication.
In case of unsatisfactory or none response after two hours, a second dose of study medication was allowed.
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