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Some underestimation due to workers absent with LBP on the day of enrollment is possible, although we enrolled at sites on multiple dates and intentionally sought to enroll those not present at the prior enrollments, thus reducing this potential source of selection bias.
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All study candidates were informed about this study and written informed consent was obtained from every participant prior enrollment.
In addition, we excluded patients without one year of prior enrollment in Medicare fee-for-service or without one month of post-discharge enrollment.
Informed consent was obtained from all patients prior to enrollment into vaccination trials (enrollment 1999 2005).
Of the 2327 enrollees, 21.2% were hospitalized at enrollment or during the 6 months prior to enrollment, and 36.2% were hospitalized in the year prior to enrollment.
Enrollment characteristics and previous relapse therapies prior to enrollment.
All enrolled patients provided written informed consent for treatment with the VizAblate System prior to enrollment.
All the patients provided informed consent prior to enrollment.
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Patient expectations regarding pain relief should be assessed and discussed prior to enrollment in the study.
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