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Briefly, a total of 1435 HIV-positive pregnant women were recruited at two antenatal care clinics in Lusaka between May 2001 and September 2004 if they intended to breastfeed, accepted to take single-dose nevirapine to prevent perinatal HIV transmission and consented to be assigned to either of the study and control groups.
A total of 347 patients consented to be randomly assigned to eradication therapy (172 patients) or placebo (175 patients).
Eligible participants were identified shortly after a GDM diagnosis; 83.8% consented to be randomly assigned to intervention or usual medical care (96 and 101 women, respectively).
Every participant that consented to the study was assigned a unique study number.
Patients eligible for the study who consented to participate were randomly assigned in a 1 1 ratio using a computer-generated block of 4, into 2 groups.
Counselling was delivered by the patients' physicians and a physiotherapist and each session lasted ∼30 min. Consecutive patients who consented to participate were randomly assigned to one of two groups, "control" or "pedometer", by the investigators based on a random number sequence generated in Excel (Microsoft, Redmond, WA, USA) before enrolment commenced.
After a patient consented to the study, the Clinical Trials Office CTOO) assigned a study number to the patient corresponding to either of the two groups.
Most female immigrants of non-western origin will not consent to a male assigned GP for a gynaecological examination, or even be alone with a male assigned GP in a closed room.
Six GPs consenting to participation are non-randomly assigned to the control arm.
The patient will be blinded to the group to which they are assigned before they consent to participate in the study.
Relatives recruited through advertisements placed in a local newspaper and through community organizations were also screened for eligibility, consented and assigned to a focus group by phone.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com