Pan, Kathy
Aragaki, Aaron K.
Neuhouser, Marian L.
Simon, Michael S.
Luo, Juhua http://orcid.org/0000-0002-8901-4462
Caan, Bette
Snetselaar, Linda
Mortimer, Joanne E.
Manson, JoAnn E.
Kroenke, Candyce
Lane, Dorothy
Reding, Kerryn
Rohan, Thomas E.
Chlebowski, Rowan T.
Article History
Received: 28 August 2020
Revised: 5 March 2021
Accepted: 24 March 2021
First Online: 18 May 2021
Ethics approval and consent to participate
: The WHI project was reviewed and approved by the Fred Hutchinson Cancer Research Center (Fred Hutch) IRB in accordance with the U.S. Department of Health and Human Services regulations at 45 CFR 46 (approval number: IR# 3467-EXT). Participants provided written informed consent to participate. Additional consent to review medical records was obtained through signed written consent. Fred Hutch has an approved FWA on file with the Office for Human Research Protections (OHRP) under assurance number 0001920. The trial was performed in accordance with the Declaration of Helsinki.
: Not applicable.
: The following data will be made available beginning 1 July 2022: the identified participant data and data dictionary (information about data sharing for the Women’s Health Initiative can be found at ExternalRef removed). For these analyses, data will be publicly available two years after the publication of this paper. The following supporting documents are available: statistical/analytical and informed consent form (ExternalRef removed).
: Rowan T. Chlebowski is a consultant for Novartis, AstraZeneca, Genentech, Merck, Immunomedics, and Puma and received honorarium from Novartis and AstraZeneca. None of the other authors report any competing interests related to this study.
: The WHI program is supported by the National Heart, Lung and Blood Institute, National Institutes of Health, Department of Health and Human Services through contracts N01WH22110, 24152, 32100-2, 32105-6, 32108-9, 32111-13, 32115, 32118-32119, 32122, 42107-26, 42129-32 and 44221. HHSN268201600003C, HHSN268201600004C and R25CA203650 also partially supported the development of this paper.