Phase 1 randomized trials to assess safety, pharmacokinetics, and vaginal bleeding associated with use of extended duration dapivirine and levonorgestrel vaginal rings

• Sharon L. Achilles ,

  Roles Conceptualization, Investigation, Methodology, Project administration, Resources, Supervision, Visualization, Writing – original draft, Writing – review & editing

  * E-mail: sla40@pitt.edu

  Current address: Bill & Melinda Gates Foundation, Seattle, Washington, United States of America

  Affiliations Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America

  https://orcid.org/0000-0002-7478-8262

  ⨯
• Clifton W. Kelly,

  Roles Formal analysis, Methodology, Software, Validation, Visualization, Writing – original draft, Writing – review & editing

  Affiliation Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America

  ⨯
• Craig J. Hoesley,

  Roles Investigation, Methodology, Resources, Supervision, Writing – review & editing

  Affiliation University of Alabama at Birmingham Heersink School of Medicine, Birmingham, Alabama, United States of America

  ⨯
• Diana L. Blithe,

  Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing

  Affiliation National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America

  ⨯
• Jill Brown,

  Roles Methodology, Supervision, Writing – review & editing

  Current address: Uniformed Services University of the Health Sciences, Bethesda, Maryland, United States of America

  Affiliation National Institute of Child Health and Human Development, Contraceptive Development Program, DIPHR, NIH, Bethesda, Maryland, United States of America

  https://orcid.org/0000-0003-1615-4584

  ⨯
• Barbra A. Richardson,

  Roles Conceptualization, Formal analysis, Investigation, Methodology, Supervision, Writing – review & editing

  Affiliations Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America, Department of Biostatistics, University of Washington, Seattle, Washington, United States of America

  ⨯
• Brid Devlin,

  Roles Resources, Writing – review & editing

  Affiliation International Partnership for Microbicides, Silver Spring, Maryland, United States of America

  ⨯
• Craig W. Hendrix,

  Roles Formal analysis, Investigation, Methodology, Validation, Writing – review & editing

  Affiliation Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America

  ⨯
• Samuel M. Poloyac,

  Roles Methodology, Validation, Writing – review & editing

  Current address: University of Texas at Austin, College of Pharmacy, Austin, Texas, United States of America

  Affiliation Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America

  ⨯
• Mark A. Marzinke,

  Roles Formal analysis, Investigation, Methodology, Supervision, Validation, Writing – review & editing

  Affiliation Department of Medicine, Division of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, United States of America

  ⨯
• Holly Gundacker,

  Roles Formal analysis, Methodology, Supervision, Validation, Writing – review & editing

  Affiliation Statistical Center for HIV/AIDS Research & Prevention, Fred Hutchinson Cancer Center, Seattle, Washington, United States of America

  ⨯
• Devika Singh,

  Roles Investigation, Supervision, Writing – review & editing

  Affiliation Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America

  ⨯
• Jeanna M. Piper,

  Roles Conceptualization, Methodology, Project administration, Supervision, Writing – review & editing

  Affiliation National Institutes of Allergy and Infectious Disease, NIH, Bethesda, Maryland

  ⨯
• Sherri Johnson,

  Roles Methodology, Project administration, Supervision, Writing – review & editing

  Affiliation FHI 360, Durham, North Carolina, United States of America

  ⨯
• John Steytler,

  Roles Resources, Writing – review & editing

  Affiliation International Partnership for Microbicides, Silver Spring, Maryland, United States of America

  ⨯
• Beatrice A. Chen,

  Roles Conceptualization, Investigation, Methodology, Project administration, Resources, Supervision, Writing – review & editing

  Affiliations Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, Pennsylvania, United States of America, Magee-Womens Research Institute, Pittsburgh, Pennsylvania, United States of America

  https://orcid.org/0000-0002-4437-4632

  ⨯
•  [ ... ],
• on behalf of the MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trials Network and the Contraceptive Clinical Trials Network

  ¶Membership of the MTN-030/IPM 041 and MTN-044/IPM 053/CCN019 Protocol Teams for the Microbicide Trails Network and the Contraceptive Clinical Trials Network is provided in the Acknowledgments

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