Study design a.We conducted a randomized, international, multicenter, double-blind study of the immunogenicity, efficacy, and side-effect profile of the 9vHPV vaccine in women 16 to 26 years of age. Phase 2b–3 study of the 9vHPV vaccine in 14,215 women. Participants received the 9vHPV vaccine or the qHPV vaccine in a series of three intramuscular injections on day 1 and at months 2 and 6. The primary efficacy hypothesis was that, as compared with the qHPV vaccine, the 9vHPV vaccine would reduce the combined incidence of several conditions related to HPV- 31, 33, 45, 52, and 58 in women 16 to 26 years of age who were seronegative on day 1 and for whom there were negative results on PCR assays for the relevant HPV type from day 1 through month 7.⁴ b. The study investigated HPV prevalence and type distribution by restriction fragment mass polymorphism (RFMP) testing a total of 60,775 specimens (aged 18-79 yr, median 44) taken from liquid-based cytology from september 2006 to september 2011. QIAamp1 DNA Blood Mini Kits were used to extract cervical cell DNA according to the manufacturer’s protocol. All tests were two-sided, and a P value<0.05 was considered statistically significant.⁵ c. The study was conducted to estimate the prevalence of genital HPV infection and the HPV vaccination rate in the United States among adult men and to examine potential risk factors for HPV infection. The National Health and Nutrition Examination Survey (NHANES) samples a representative cross-section of the US population. Men aged 18 to 59 years were examined in mobile examination centers during the NHANES 2013-2014. DNA was extracted from self-collected penile swab specimens, and HPV genotyping was performed by polymerase chain reaction amplication. Demographic and vaccination information was gathered via self-report during home-based standardized interviews. Binary multivariable logistic regression was used to estimate the odds of HPV infection. Main outcomes were the prevalence of genital HPV infection and the HPV vaccination coverage rate among adult men.¹⁵ d. A retrospective case-control analysis was conducted to evaluate the genotype-specic risk for cervical carcinogenesis and the distribution of HPV types according to age in different cervical lesions. Study samples were collected from HPV-positive women who underwent cervical biopsy between July 2011 and December 2017. A total of 1,988 samples were collected from women with normal (n=400), CIN 1 (n=399), CIN 2 (n=400), CIN 3 (n=400), cervical cancer (n=399). ²⁰ e. Independent, prospective, multicenter, hospital-based cross-sectional studies were conducted across 5 countries in Asia, namely, Malaysia, Vietnam, Singapore, South Korea, and the Philippines. The objectives of these studies were to evaluate the prevalence of human papillomavirus(HPV) types (high risk and others including coinfections) in women with invasive cervical cancer (ICC) and high-grade precancerous lesions. Women older than aged 21 with a histologic diagnosis of ICC and cervical intraepithelial neoplasia[CIN 2 or 3 and adenocarcinoma in situ (AIS)] were enrolled. In the 5 Asian countries, diagnosis of ICC was confirmed in 500 women [SCC (n=392) and ADC/ASC (n=108)], and CIN 2/3/AIS in 411 women.²¹ f. To estimate GW prevalence, physicians in five major South Korean regions recorded daily logs of patients (n=71,655) seeking care between July 26 and September 27, 2011. Overall prevalence estimates (and 95% CIs) were weighted by the estimated number of physicians in each specialty and the estimated proportion of total patients visiting each specialist type. Healthcare resource use was compared among different specialties. GW prevalence of new or existing cases was calculated by physician specialty type, based on the number of new or existing cases observed, divided by the total number of patients who were seen during the 2-week study period. Using the national population (18–60 years) and the prevalence of GW in South Korea, the age-adjusted estimate for the number of GW cases in South Korea was projected.²⁹ g. The international study was conducted to gauge the emotions and concerns of patients with genital warts; to determine what, if any, risks are perceived to be associated with genital warts; and to understand patients’ perceptions regarding the treatment they receive. The study group included 80 men and 86 women with genital warts. A standardized discussion guide used to interview patients with genital warts in Canada, France, Germany, the UK, and the USA about their perceptions and concerns regarding the diagnosis, treatment, and psychosexual impact of the disease. Interviews were conducted in person and lasted approximately 30 min.³⁰

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