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Oklahoma is the first state to conduct a formal "market conduct examination," visiting a company's offices and reviewing its files to assess sales practices.
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The baseline (visit 1) and 4-, 10- and 14-year follow-up examinations (visits 2 4) in 1984 1986, 1990 1992, and 1994 1996, respectively, included color stereoscopic photographs that were taken and graded as described above and previously (4, 10).
Questionnaire data are obtained during examination visits using a computer-assisted telephone interviewing system.
Patients were asked to return one week after each examination visit for laboratory results.
The questionnaires were checked by survey staff during the examination visit.
Participants were asked to bring the completed FFQ with them during their examination visits.
A sample for the pharmacogenetic analysis was taken at a separate examination visit before the prestudy examination.
An end-of-study examination (visit 4) was performed within 7 days after completion of visit 3.
Unused products were to be returned to the respective investigator during the examination visits at 3 and 6 months.
Also at every examination visit, participants respond to questions about side effects and possible serious adverse events.
A screening examination (visit 1) was performed within 21 days before the first administration of the drug.
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