Introduction: Headache and migraine adverse events are common concerns in the administration of intravenous immune globulins (IVIG). Trials of IVIG for primary immunodeficiency (PI) are typically small and have reported headache and migraine data inconsistently.
Methods: We analyzed headache and migraine in pooled data from three pivotal trials of Gammaplex 5% and 10% in PI (NCT00278954 from January 18, 2006; NCT01289847 from January 27, 2011; NCT01963143 from September 13, 2013).
Daily maximum 8-hour average (MDA8) ozone (O) concentrations are well-known to be influenced by local meteorological conditions, which vary across both daily and seasonal temporal scales. Previous studies have adjusted long-term trends in O concentrations for meteorological effects using various statistical and mathematical methods in order to get a better estimate of the long-term changes in O concentrations due to changes in precursor emissions such as nitrogen oxides (NO) and volatile organic compounds (VOCs). In this work, the authors present improvements to the current method used by the United States Environmental Protection Agency (US EPA) to adjust O trends for meteorological influences by making refinements to the input data sources and by allowing the underlying statistical model to vary locally using a variable selection procedure.
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