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The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3\u00a0months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16\/Ki-67 test. At 6\u00a0months a further cytology and p16\/Ki-67 test was performed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Regression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16\/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6\u00a0months the cytological regression in the treatment group and the highly significant effect on p16\/Ki-67 was still present.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>SAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16\/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ISRCTN11009040, date of registration: 10\/12\/2019;\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/doi.org\/10.1186\/ISRCTN11009040\">https:\/\/doi.org\/10.1186\/ISRCTN11009040<\/jats:ext-link>\n                      ; retrospectively registered.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00404-020-05816-8","type":"journal-article","created":{"date-parts":[[2020,11,20]],"date-time":"2020-11-20T13:03:31Z","timestamp":1605877411000},"page":"501-511","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16\/Ki-67: a randomized controlled trial"],"prefix":"10.1007","volume":"303","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1459-2727","authenticated-orcid":false,"given":"Attila Louis","family":"Major","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vladim\u00edr","family":"Dvo\u0159\u00e1k","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jana","family":"Schwarzov\u00e1","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ale\u0161","family":"Sk\u0159iv\u00e1nek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tom\u00e1\u0161","family":"Mal\u00edk","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marek","family":"Pluta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ivanna","family":"Mayboroda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Etienne Marc","family":"Grandjean","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,11,20]]},"reference":[{"key":"5816_CR1","doi-asserted-by":"publisher","first-page":"2100","DOI":"10.1001\/jama.291.17.2100","volume":"291","author":"L Sadler","year":"2004","unstructured":"Sadler L, Saftlas A, Wang W, Exeter M, Whittaker J, McCowan L (2004) Treatment for cervical intraepithelial neoplasia and risk of preterm delivery. 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ALM has received speaking honoraria and JS honoraria for study coordination and monitoring from the sponsor of the study. All other authors declare that they have no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability (software application or custom code)"}}]}}