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The appropriate ethics and regulatory approvals were obtained before study initiation, and written informed consent was obtained from all participants.
Each participating PPMI site received approval from a local research ethics committee before study initiation and obtained written informed consent from all subjects participating in the study.
Sponsors and investigators should take reasonable efforts, plan before study initiation and discuss with benefits and risk of study with local communities.
Ethical approval was obtained from all ethical review boards of the participating centers before study initiation and written informed consent from each patient before entering the study.
Ethical approval was obtained from the local ethical review board before study initiation and written informed consent from each patient before entering the study.
The study protocol was approved by local ethics committees before study initiation, and all patients provided written informed consent before inclusion in the trial.
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In designing our trial, we based our estimate of HIV incidence on the national HIV prevalence in Nigeria reported two years before study initiation [ 4- 6], and on the incidence-to-prevalence ratio of 2.4 from previous research conducted by Family Health International (FHI) among similar study populations in West Africa [ 7].
For the genetic analysis, written informed consent (from the subject or from the responsible guardian if the subject was incapable) was obtained, before study initiation, for blood collection and genotyping.
Written informed consent was obtained from participants (mothers) before study initiation, in accordance with both Brigham and Women's Hospital and Beth Israel Deaconess Medical Center Human Subjects Committees.
Human subject review and approval was obtained through CDC and the Minnesota Department of Health before study initiation.
Written consent forms approved by The Committee of Human Rights in Research in Menoufia University were obtained from studied cases and control subjects before study initiation.
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