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All patients, regardless of CD4 count, are provided with a referral slip for the on-site HIV care clinic and instructed to enroll in care as soon as possible, although particular emphasis on prompt enrollment is provided to patients who are ART eligible as described below.
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The average gross income in the municipality of residence at the time of enrollment was provided by Statistics Denmark.
Information on in utero exposure to maternal smoking, the child's history of previous SHS exposure, and number of smokers in the home at study enrollment was provided in the baseline questionnaire.
A CONSORT 2010 diagram of study enrollment and participation is provided in Figure 2 (CONsolidated Standards Of Reporting Trials).
Information in the database, such as contact telephone numbers and location of practice, is provided during enrollment or during membership renewals, and no active verification is done.
The main instruction occurred at the baseline enrollment visit, but further instruction is provided when deemed appropriate at subsequent study visits or on an ad hoc basis if subjects require additional assistance.
A research participant's consent to participate in pharmaceutical PGx research is often either captured as part of the main consent form used for enrollment in the clinical trial, or is provided as a supplementary consent at the same time as the main consent.
Subjects completed the UC-PRO/SS (9 candidate items) and Module 3 Systemic Symptoms (5 candidate items), a patient global rating of disease severity, and a single item to assess the "worst pain" [12] each day during the 30-day study period, using an electronic hand-held device given to the subject upon enrollment; training was provided by clinical site personnel.
Complete enrollment criteria are provided in the online supplemental material.
At enrollment, participants were provided with detailed information on the mechanics of gel use, including how to assemble the applicator and how to insert the applicator and eject the gel into the vagina.
The subjects recruited into the Patient Intervention received a home blood pressure monitor at their enrollment visit and are provided with a health coach to assist them with their self-management efforts via counseling provided over the phone.
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