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  "documentTitle": "Dare Bioscience | Investor Presentation Deck | 50 slides",
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  "authorName": "Daré Bioscience",
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  "presentationDate": "2022-10-01 00:00:00",
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  "notes": "The slide details the methodology of a clinical trial, including randomization, dosing groups, and primary/secondary endpoints.",
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      "text": "The Phase 1/2 study will evaluate different doses of DARE-VVA1, a tamoxifen vaginal insert, in approximately 15-20 postmenopausal women with VVA, including a cohort of women with a history of breast cancer.\nThe study is a randomized, multi-center, double-blind, parallel-arm, placebo-controlled, dose-ranging study that will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and pharmacodynamics (PD) of DARE-VVA1.\nEligible participants will be randomly allocated to one of five treatment groups (up to 5 participants per group) that will evaluate four dose levels (1 mg, 5 mg, 10 mg, and 20 mg) and a placebo.\nFollowing a screening visit, DARE-VVA1 will be self-administered intravaginally once a day for the first two weeks, and then twice a week for the following six weeks for a total treatment period of 56 days.\nIn each treatment group, participants will have serial blood sampling for PK analysis and undergo safety evaluations and preliminary assessments of effectiveness. Following the completion of the treatment period, participants will attend a safety follow-up visit.",
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      "text": "The primary endpoints of the study will evaluate the safety and tolerability of DARE-VVA1 by vaginal administration and determine the plasma PK of DARE-VVA1 after intravaginal application.\nSecondary endpoints will evaluate preliminary efficacy and PD of DARE-VVA1 in terms of most bothersome symptom and changes in vaginal cytology and pH.",
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      "text": "Phase 1/2 study is designed to evaluate the safety, pharmacokinetics and pharmacodynamics of DARE-VVA1 in postmenopausal participants with moderate to severe VVA and is being conducted by the Company's wholly owned subsidiary in Australia.",
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      "text": "1. https://ir.darebioscience.com/news-releases/news-release-details/dare-bioscience-initiates-phase-12-clinical-study-dare-vva1",
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      "text": "DARE-VVA1 – Phase 1/2 Study",
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