ART use and baseline CD4+ cell count data were taken from the main clinical trial database and used as independent variables.
Data for visit attendance for pharmacy refills were also taken from the main clinical trial database and used for descriptive purposes.
Also, the large number of patients who reported complaints of sexual functioning, fatigue, and insomnia in the QoL study was not mirrored by the reported adverse events related to these complaints in the main TEAM trial database.
With respect to specific aspects of QoL such as sexual functioning, fatigue, and insomnia, significantly more patients reported complaints of these items in the QoL side study than that adverse events related to these specific complaints were documented in the main TEAM trial database.
This gave 7 out of 37 clinical trials (with 4 CTIMPs) not registered on any of the three main trial registration databases, although these trials had commenced prior to the requirement for registration.
The trial database was maintained as blind until all data collection, checking, and cleaning for the main efficacy analyses had taken place; after this, participant condition was downloaded from the randomization service and inserted into the database.
Other defendants in the main trial, set to start Feb. 27, include a former police officer charged with giving Mr. Pellicano information from law-enforcement databases; a phone company worker accused of installing wiretaps; and a programmer accused of writing wiretap software and destroying evidence.
One of those lawmakers, Senator Kennedy, has said he plans to introduce legislation calling for a federally run trial database.
There's already an EU clinical trial database, but unlike the American one, it's not open to the public.
The state Supreme Court is the main trial court in New York.
