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As we aimed to replicate the standard practice of a helpline, we offered enrolment to the trial to all smokers who contacted the helpline (by telephone, internet, or interactive TV), wanted help with cessation, and were willing to accept standard care by the quitline.
From June 1998 to August 1999, all infants born at full term of pregnancy (≥ 37 weeks) and aged 6 to 9 weeks, who were to start their national vaccination program, were offered enrolment to the open, uncontrolled, descriptive study at the village health centre in Cabuyao, a semi-urban municipality of Laguna, Island of Luzon, the Philippines.
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Patients will be offered enrolment, when in addition to CBP they additionally fulfill the criteria for experienced psychological trauma (see Table 1).
Parents of patients were offered enrolment in this study, where appropriate, to clarify their children's genetic test results.
Patients tested initially and found to be G6PD deficient will be excluded from the randomised study but offered enrolment in a single arm non-randomised observational study to receive standard schizontocidal therapy plus primaquine 0.75 mg/kg/week for 8 doses (total dose 6 mg/kg).
From July to September 2006, consecutive HIV-positive adults ≥18 years old, not currently on ART and presenting to any one of the 12 study sites were offered enrolment into the study.
Inclusion criteria: infants aged 5 to 16 weeks who were resident in Asembo (study area), when they attended a Mother and Child Health clinic prior to their first OPV/PENT vaccination at any one of the 4 study clinics located in 3 large outpatient healthcare units and 1 mission hospital within the study area were offered enrolment in the study.
However from July 2003, all women attending antenatal visits were offered enrolment before HIV testing.
Unregistered FSW were offered enrolment (if eligible) when presenting for routine assessment at the mobile clinic.
Consecutive eligible patients seen in a single private practice, California Retinal Consultants (CRC), were sequentially offered enrolment into the study.
Patients who completed the 12-week treatment period were offered enrolment in a long-term extension study, NCT01118728.
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