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We thus selected weeks 45-48 as the primary analysis period.
During the primary analysis period, just two vaccinated cases were identified (table 3).
During the primary analysis period, all vaccinated participants reported having received a single dose.
During the primary analysis period between week 45 (8 November) and week 48 (5 December), 867 specimens were submitted.
After we applied inclusion and exclusion criteria, 552 participants were available for the primary analysis period (table 1).
During the primary analysis period, 11% (60/552) of participants reported receipt of pandemic H1N1 vaccine at least two weeks before onset of illness.
Similar(48)
Two patient groups were defined; those with ≥1 viral load assessment during the 4- to 30-week follow-up period (primary analysis of SVR rates), and a subgroup with an assessment from 12 to 30 weeks (ad hoc analysis) representing SVR12, the commonly accepted reference for cure American Association for the Study of Liver Disease/Infectious Diseases Society of America (AASLD/IDSA) [ 11].
To explore the robustness of the primary analysis, a supportive analysis of period 1 alone was examined.
The distribution of characteristics was similar between the primary and secondary analysis periods (not shown).
For this reason, we chose the post-index observation period as our primary analysis.
As steady-state exenatide concentrations were maintained over time, the primary analysis could focus on the time period of greatest stability in pharmacodynamic variables, which was confirmed by stable serum glucose concentrations over the primary ECG assessment window.
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