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A second study population consists of 120 HIV-1 infected intravenous drug users (DU) that participate in the Amsterdam Cohort Studies on HIV and AIDS among intravenous drug users which started enrolment in 1985.
The women were part of a large study examining the risks of postnatal HIV transmission associated with different modes of infant feeding[15], [16], which started enrolment at the same time as a Prevention of Mother-to-Child Transmission (PMTCT) programme was implemented in the area.
We started enrolment of participants in February 2012.
The first municipality started enrolment in February 2013 and the last municipality started inclusion in February 2014.
Seven of 13 trials (54%) published in 2002 cited the review and it is possible that some of these trials had started enrolment of patients before the publication of the review.
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The registration policy is applicable to any trial starting enrolment after 1 July 2005.
Follow-up times started from enrolment.
The Phime study started the enrolment of women during pregnancy in April 2007; the 18 months follow up started in January 2009.
Two treatment effects need to be considered: (1) prior treatment (started before enrolment in the study) and (2) subsequent treatment started during study follow-up (treatment drop-ins).
A phase III trial of adjuvant metformin has been initiated in women with breast cancer (NCIC CTC MA.32) [ 9] and a phase II trial of a neoadjuvant setting for postmenopausal breast cancer patients (METEOR study) has also started patient enrolment [ 10].
After a slow start, enrolment picked up, with a dramatic rise in the number of people visiting the exchanges in the days and weeks leading up to the 31 March deadline.
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