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Table 5 lists all dose-related adverse reactions occurring in at least 2% of all LYRICA-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received LYRICA and 294 patients received placebo for up to 12 weeks. Because patients were also treated with 1 to 3 other AEDs, it is not possible to determine whether the following adverse reactions can be ascribed to LYRICA alone, or the combination of LYRICA and other AEDs. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.
Scientists continue to work on better ways to design, conduct and evaluate non-randomized (., observational) studies to assess how well flu vaccines work. CDC has been working with researchers at universities and hospitals since the 2003-2004 flu season to estimate how well flu vaccine works through observational studies using laboratory-confirmed flu as the outcome. These studies currently use a very accurate and sensitive laboratory test known as RT-PCR (reverse transcription polymerase chain reaction) to confirm medically-attended flu virus infections as a specific outcome. CDC’s studies are conducted in five sites across the United States to gather more representative data. To assess how well the vaccine works across different age groups, CDC’s studies of flu vaccine effects have included all people aged 6 months and older recommended for an annual flu vaccination. Similar studies are being done in Australia, Canada and Europe. More recently, CDC has set up a second network the Hospitalized Adult Influenza Vaccine Effectiveness Network (HAIVEN) that looks at how well flu vaccine protects against flu-related hospitalization among adults aged 18 and older.