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Before randomization, a nurse went to each participant's home and, after obtaining informed consent, collected baseline demographic and clinical data.
The protocol was approved by the local ethics committee, and informed written consent collected from all participants.
There was no consent collected at the time, as it is a historical cohort started 60 years ago; but this deemed acceptable by the ethics committees, if data used in an anonymised form - as they are throughout the analysis.
JG acquired patient consent, collected intra-operative measurements, collated patient data, and contributed to revisions of the manuscript.
Finally, users can review information and graphics about temperature, study gift receipt, and consent collected by field teams.
A study team visited the home if the family was eligible, obtained consent, collected a child blood sample, conducted an extensive interview, and collected environmental samples.
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JN and EG were involved in obtaining patient consent, collecting specimens and collecting patient data.
KH, EE, JA and AH were responsible for recruiting subjects, informed consent, collecting samples, and some biomedical analysis.
RB, JC, JF, DM, and JM were responsible for recruiting patients, informed consent, collecting samples, and some biomedical analysis.
The research nurse will ask eligible women to participate, explain the trial and obtain informed consent, collect baseline data and ask women to self-collect a vaginal swab.
Though banking protocols and processes differ slightly among institutions, all must have processes for identifying potential subjects and obtaining consent, collecting specimens and capturing data.
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