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From these households, all eligible subjects were recruited until the target sample size of this study was reached.
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The participants in this study were reached using the database of SAfH and Turkish community centres working with together.
The primary endpoints for this study were reached at 21 days after the second vaccination, with immune responses fulfilling all CHMP and CBER criteria for the vaccine-homologous HI antibody response (A/Indonesia/5/2005, Clade 2.1).
With 42% of patients free of progression at 6 months, the main objective of the study was reached.
Since the older adolescents in this study were reaching the age for being autonomous users of health services, according to Norwegian legislation, this finding indicates that increased awareness of easily available health care follows increasing age in our sample.
Low accrual led to trial suspension before the predetermined sample size for either study was reached.
In light of the results, we can conclude that the objective of our study was reached.
Owing to slow accrual, recruitment was suspended before the predetermined sample size for each study was reached.
Patients were further followed for safety and pharmacokinetic assessments, and a formal end of study was reached at day 113.
Consensus of inclusion of the studies was reached by discussion.
Overall enrollment will be completed when the planned sample size for the entire study is reached.
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