Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Worldwide, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Immunogenicity, and Efficacy on the Incidence of HPV 16/18-Related CIN 2/3 or Worse of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year Old Women - The FUTURE II Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)
Brief Summary: The primary purpose of the study is to determine if GARDASIL™ (V501) is able to prevent cervical cancer.


Options:
A: Inclusion Criteria:

* Patients who present with vulvar or vaginal dysplasias or condylomas that require surgical intervention will be informed of the study by the treating physician
* Pre-operative biopsies to confirm presence of dysplasia / condyloma. Patients with dysplasias of grade 3 / CIS will be included at the discretion of the treating surgeon and will have had invasion confidently excluded by clinical exam and biopsy.

Exclusion Criteria:

* Patients under the age of eighteen or who are pregnant will be excluded
B: Inclusion Criteria:

* Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

* Prior Human Papillomavirus (HPV) vaccination
* Prior abnormal paps
* History of genital warts
C: DISEASE CHARACTERISTICS:

* Histologically confirmed perianal high-grade squamous intraepithelial lesions (HSIL) within the past 12 weeks

  * The perianal skin (i.e., perianus) is defined as extending radially 5 cm from the anal verge
  * Lesions must cover a surface area of ≥ 3 square centimeters
  * Lesions extending outside the perianus (e.g., vulvar lesions on the posterior perineum bordering the perianus) are allowed
* Serologic documentation of HIV infection AND meets 1 of the following criteria:

  * Has been on stable highly active anti-retroviral therapy (HAART) for ≥ 12 weeks prior to study entry
  * Has a CD4 count of \> 200/mm³ AND is not receiving anti-retroviral therapy OR is currently receiving a non-HAART\* anti-retroviral regimen with no plans to initiate HAART within the next 12 weeks NOTE: \* A non-HAART regimen is considered to be a therapy that does not include a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor
* No untreated invasive cancer of the lower genital tract
* No concurrent neoplasia requiring cytotoxic therapy

PATIENT CHARACTERISTICS:

* Karnofsky performance status 70-100%
* Life expectancy ≥ 3 months
* Hemoglobin ≥ 8 g/dL
* ANC ≥ 1,000/mm³
* Platelet count ≥ 75,000/mm³
* Creatinine \< 1.5 times upper limit of normal (ULN)
* Total or conjugated (direct) bilirubin ≤ 2.5 times ULN
* AST and ALT ≤ 3 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of study therapy
* No acute, opportunistic infection other than oral thrush, yeast vaginitis, or genital herpes within the past 14 days

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from prior ablative or surgical treatment of perianal dysplasia
* At least 4 weeks since prior topical treatment for perianal dysplasia

  * If any prior treatment caused significant trauma to ther area, healing should occur prior to starting treatment
* More than 14 days since prior acute treatment for infection (other than for oral thrush, yeast vaginitis, or genital herpes) or other serious medical illness
* No concurrent corticosteroids other than replacement doses
* No other concurrent investigational drugs except IND-approved anti-retroviral agents
* No concurrent systemic cytotoxic chemotherapy
D: Inclusion Criteria for the Base Study:

* Healthy women with an intact uterus with lifetime history of 0-4 sexual partners

  --For Extension Phase:
* Participant received placebo or an incomplete vaccination series in the original study

  --For LTFU:
* Participant was randomized into the Base Study from Denmark, Iceland, Norway, or Sweden.
* Agreed to allow passive follow-up (retrospective review of registry data), analysis of biopsy specimens, future contact from National Registry Study Center and serum collection

Exclusion Criteria for the Base Study:

* Prior Human Papilloma Virus (HPV) vaccination
* Prior abnormal Paps
* Prior history of genital warts

  --For Extension Phase:
* Prior complete HPV vaccination series
* Subject lives in a country in which Gardasil is approved and is within the age range of the local labeling for Gardasil

  --For LTFU Study:
* There were no exclusion criteria that did not overlap the inclusion criteria for this study.

Answer: D