An Assessment of the NIH Women's Health Initiative (1993) / Chapter Skim
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Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health
Appendix D: Documents Received by the Institute of Medicine from the National Institutes of Health
Pages 105-108
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From page 105... ...
NTH-WH-92-19-E Vanguard Clinical Centers for Clinical Trials and Observational Study of the Women's Health Initiative Dated 4/29/92 Amendments to Solicitation NTH-WH-92-19-E Vanguard Clinical Centers for Clinical Trials and Observational Study of the Women's Health Initiative Dated 4/29/92 Information to Offerors Subheadings Scientific Information Objectives Inclusion Criteria for Clinical Trial Exclusion Criteria for Clinical Trial Enrollment Key Baseline and Follow-Up Variables Clinical Outcomes of Interest Partial Factorial Design Testimony from NTH Women's Health Initiative Public Hearing, October 28-29, 1991. Received: May 25, 1993 · May 13, 1993 Protocol (was not yet approved)
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From page 106... ...
Thau] letter REP: July 7, 1993 Power calculations and sample size information from Laurence Freedman Additional quality of life construct information from Robert Kaplan Journal articles on clinical trials Incidence tables on colorectal cancer, hip fractures, and other fractures Received: July 26, 1993 Additional response to June 29, 1993 Dr.
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From page 107... ...
Thau] letter · Memo from Jacques Rossouw, with attachments: age distribution; rate calculations; power calculations; discussion of dietary modification and breast cancer hypothesis; Hollinghead scale; adjustments to minority group rate; budgets for additional 6,000 WHT CT participants; subcommittee membership rosters; Data Safety and Monitoring Board documents; memo from Mark Kestin on plasma triglycerides and a low fat diet; information on why calcium and vitamin D are combined in the Clinical Trial; minutes from the Concept Review meeting for the Clinical Trial and Observational Study; and - the scripts for the VCC videotapes.
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From page 108... ...
contract dates · Additional description and cost information of NTH-sponsored women's health studies
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