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React from \"react\";\nimport { Link } from \"gatsby\"\n\nexport default function Callout({\n  children,\n  className,\n  calloutTitle,\n  buttonTitle,\n  buttonLink,\n  bodyCopy,\n  isTargetBlank\n}) {\n  return (\n    <div className={`callout ${className}`}>\n      <div className=\"inner-container\">\n        <div className=\"callout-title\" dangerouslySetInnerHTML={{ __html: calloutTitle }} />\n        {\n          bodyCopy ?\n            <div className=\"callout-content\" dangerouslySetInnerHTML={{ __html: bodyCopy }} />\n            :\n            <div className=\"callout-content\">\n              {children}\n            </div>\n        }\n        <div className=\"callout-button-container\">\n          {isTargetBlank ? 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<p>\n        Talking with your doctor about treatment options may be a little easier\n        with the Doctor Discussion Guide.\n      </p>\n    </Callout>\n  );\n}\n","import React from 'react';\nimport Callout from './callout';\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout calloutTitle=\"Become a REMS-Certified Provider\" buttonTitle=\"How Can You Become REMS&#x2060;-&#x2060;Certified\" buttonLink=\"https://aveedrems.com/\" isTargetBlank={true} bodyCopy={bodyCopy}>\n      <p>Learn how you can become a prescriber through the AVEED<sup>&reg;</sup> REMS<sup>&dagger;</sup> Program.</p>\n    </Callout>\n  )\n}\n","import React from 'react';\nimport Callout from './callout';\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout calloutTitle=\"You Might Be Eligible for Savings\" buttonTitle=\"See If You Are Eligible\" buttonLink=\"/paying-for-aveed/\" bodyCopy={bodyCopy}>\n      <p>If you have been prescribed AVEED<sup>&reg;</sup>, you may be eligible for savings with the AVEED<sup>®</sup> Copay Assistance Program.</p>\n    </Callout>\n  )\n}\n","import React from 'react';\nimport Callout from './callout';\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout\n      calloutTitle=\"View the Patient Brochure\"\n      buttonTitle=\"Download Brochure\"\n      buttonLink='https://d1skd172ik98el.cloudfront.net/48a33315-f594-4269-8043-8853d10fb7bf/013a795b-4679-488e-b082-9d609631dacc/013a795b-4679-488e-b082-9d609631dacc_source__v.pdf'\n      isTargetBlank={true}\n      bodyCopy={bodyCopy}\n    >\n      <p>Learn more about hypogonadism, treatment with AVEED<sup>&reg;</sup>, and how to save.</p>\n    </Callout>\n  )\n}\n","import React from 'react';\nimport Callout from './callout';\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout calloutTitle=\"Get Important Information About AVEED<sup>&reg;</sup>\" buttonTitle=\"View Medication Guide\" buttonLink=\"https://endodocuments.com/AVEED/MG\" isTargetBlank={true} bodyCopy={bodyCopy}>\n      <p>Download a complete overview of important drug information, possible side effects, and more.</p>\n    </Callout>\n  )\n}\n","import React from 'react';\nimport Callout from './callout';\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout calloutTitle=\"AVEED<sup>&reg;</sup>&nbsp;Resources Page\" buttonTitle=\"View Now\" buttonLink=\"/resources/\" bodyCopy={bodyCopy}>\n      <p>Get downloadable Patient Brochure, Medication Guide, rebate info, and more.</p>\n    </Callout>\n  )\n}\n","import React from \"react\";\nimport Callout from \"./callout\";\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout\n      calloutTitle={`Find AVEED<sup style=\"padding-right: 4px\">&reg;</sup> Near You`}\n      buttonTitle=\"View AVEEDfinder\"\n      buttonLink=\"/aveed-finder\"\n      isTargetBlank={false}\n      bodyCopy={bodyCopy}\n    >\n      <p>\n        Use AVEEDfinder to search for healthcare professionals certified to\n        prescribe AVEED<sup>&reg;</sup> in your area.\n      </p>\n    </Callout>\n  );\n}\n","import React from 'react';\nimport Callout from '../callout';\n\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout calloutTitle=\"Patient Savings Eligibility\" buttonTitle=\"Learn About Eligibility<br/>for Your Patients\" buttonLink=\"/hcp/paying-for-aveed/\" bodyCopy={bodyCopy}>\n      <p>Depending on your patients' insurance, and other relevant factors, they may be eligible for savings.</p>\n    </Callout>\n  )\n}\n","import React from 'react';\nimport Callout from '../callout';\n\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout calloutTitle=\"How to Administer AVEED<sup>&reg;</sup>\" buttonTitle=\"View Procedure\" buttonLink=\"/hcp/dosing-and-administration/\" bodyCopy={bodyCopy}>\n      <p>Read an overview of the injection procedure and other important facts about administering AVEED<sup>&reg;</sup>.</p>\n    </Callout>\n  )\n}\n","import React from 'react';\nimport Callout from '../callout';\n\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout calloutTitle=\"Prescriber Resources\" buttonTitle=\"View Resources\" buttonLink=\"/hcp/resources/\" bodyCopy={bodyCopy}>\n      <p>Download forms, access patient education materials, and more.</p>\n    </Callout>\n  )\n}\n","import React from 'react';\nimport Callout from '../callout';\n\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout calloutTitle=\"Get Started\" buttonTitle=\"Find Out More\" buttonLink=\"/hcp/get-aveed/?scrollto=access_and_reimbursement\" bodyCopy={bodyCopy}>\n      <p>Once you're certified, you're ready to order AVEED<sup>&reg;</sup> for your patients.</p>\n    </Callout>\n  )\n}\n","import React from \"react\";\nimport Callout from \"../callout\";\nexport default function index({ bodyCopy }) {\n  return (\n    <Callout\n      calloutTitle={`Get Listed on AVEEDfinder`}\n      buttonTitle=\"View AVEEDfinder Sign-up\"\n      buttonLink=\"/hcp/aveed-finder-signup/\"\n      isTargetBlank={false}\n      bodyCopy={bodyCopy}\n    >\n      <p>Sign up with AVEEDfinder so patients can search for you.</p>\n    </Callout>\n  );\n}\n","module.exports = __webpack_public_path__ + \"static/mean-serum-testosterone_AV-05239-01-65d4012afd0899144bb99e80d8b175df.png\";","module.exports = __webpack_public_path__ + \"static/us-map-0ce3630a7928a5adf398312cd548c113.png\";","module.exports = 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gl83kr/9hTG1s9oplW9xSxm8ZGiHzEMqIXhpZGvsUPi8zMSWJ/nL1GetK3u1eMGpNw1AWCoTKJBdbDC8OlvOy9dzPrDHg72Rv6kiVQ6xQW7B4QkQCnvhOKBAB7B0gtGYzqh1PKgWB6Crg73OAm2OutqtGxsUBuSW4g+0ZTEQ7I3wryg7BwD8HzyBZ/csGg5EAAAAAElFTkSuQmCC\"","module.exports = __webpack_public_path__ + \"static/mean-steady-state-testosterone-update-7389fbc9e44de2548ede71580eda39c5.png\";","import React from \"react\";\nimport { HcpPage, SEO, Boxy } from \"components\";\nimport { Row, Col } from \"react-flexbox-grid\";\nimport { Element } from \"react-scroll\";\nimport {\n  HCPAdministration,\n  HCPSavingsCallout\n} from \"components/shared/callouts\";\n\nimport imgMean from \"images/mean-steady-state-testosterone-update.png\";\nimport imgSerum from \"images/mean-serum-testosterone_AV-05239-01.png\";\nimport imgMap from \"images/us-map.png\";\nimport imgGuy from \"images/standup-guy.png\";\nimport imgNinetyFour from \"images/ninety-four-percent.png\";\n\nimport \"./clinical-data.scss\";\n\nconst pageReferences = [\n\n  `\n  AVEED<sup>&reg;</sup> (Prescribing Information). Malvern, PA: Endo USA, Inc.\n  `,\n  `Wang C, Harnett M, Dobs AS, Swerdloff RS. Pharmacokinetics and safety of long-acting testosterone undecanoate injections in hypogonadal men: an 84-week phase III clinical trial. <em>J Androl.</em> 2010;31(5):457-465.`,\n  `Data on file. DOF-AV-01. Endo USA, Inc.; 2014.`,\n];\n\nconst pageDescription = \"View data from the clinical study for AVEED® (testosterone undecanoate) injection CIII. See Safety & PI, including Boxed Warning.\";\n\n\nconst ClinicalDataPage = () => {\n  return (\n    <HcpPage pageClassName=\"clinical-data\" references={pageReferences}>\n      <SEO pageTitle=\"Clinical Data\" pageDescription={pageDescription} />\n      <div className=\"dfa-container gutter-left gutter-right\">\n        <Element name=\"elevate_and_control\">\n          <Row>\n            <Col xs={12}>\n              <h1>\n                Elevate and Control Testosterone Levels in Hypogonadal Males\n              </h1>\n              <h2 className=\"pt-0\">\n                In the phase 3 US clinical trial<sup>1</sup>:\n              </h2>\n              <ul className=\"green\">\n                <li>\n                  <span>\n                    Hypogonadal men (morning testosterone level &lt;300 ng/dL) were given 750 mg AVEED\n                    <sup>&reg;</sup> at initiation, at 4 weeks, and every 10\n                    weeks thereafter{\" \"}\n                  </span>\n                </li>\n                <li>\n                  <span>\n                    Mean serum testosterone levels at baseline were 215 ng/dL\n                  </span>\n                </li>\n                <li>\n                  <span>\n                    Steady-state testosterone levels were achieved with the third injection at 14 weeks\n                  </span>\n                </li>\n              </ul>\n              <Boxy\n                title=\"Mean steady-state testosterone concentrations after the third AVEED<sup>&reg;</sup> injection (N=117)<sup>1-3</sup><span class='super-asterisk'>*</span>\"\n                className=\"mean-steady-block\"\n                style={{ marginTop: 10 }}\n              >\n                <img\n                  src={imgMean}\n                  alt=\"Mean steady-state testosterone concentrations after the third AVEED<sup>&reg;</sup> injection\"\n                  style={{ maxWidth: 500 }}\n                  className=\"expand\"\n                />\n              </Boxy>\n              <div>\n                <p className=\"txt-right\"><a href=\"/hcp/clinical-data?scrollto=study_design\">See Study Design</a></p>\n                <h2>\n                  Over the full 10 weeks at steady state<sup>1,2</sup>:\n                </h2>\n\n                <ul className=\"green\">\n                  <li>\n                    <span>\n                      The mean C<sub>min</sub> remained above 300 ng/dL{\" \"}\n                    </span>\n                  </li>\n                  <li>\n                    <span>\n                      7.7% of patients had a C<sub>max</sub> &gt;1500 ng/dL\n                    </span>\n                  </li>\n                  <li>\n                    <span>\n                      No patient had a C<sub>max</sub> &gt;1800 ng/dL\n                    </span>\n                  </li>\n                </ul>\n              </div>\n\n              <div className=\"us-map-block\">\n                <div className=\"img-block\">\n                  <img src={imgMap} alt=\"US Map\" />\n                </div>\n\n                <p>\n                  In the US clinical trial, mean testosterone concentrations{\" \"}\n                  <strong>\n                    remained in the normal range (300–1000 ng/dL) at all\n                    measured time points\n                  </strong>{\" \"}\n                  upon achieving steady state.<sup>2</sup>\n                </p>\n              </div>\n            </Col>\n          </Row>\n\n        </Element>\n        <hr className=\"section-separator\" />\n        <Element name=\"efficacy\">\n          <Row>\n            <Col xs={12}>\n              <p className=\"h1\">\n                Testosterone Replacement for 10 Full Weeks After the Third\n                Injection\n              </p>\n              <h2 className=\"pt-0\">\n                At steady state, mean testosterone levels remained within the\n                normal range<sup>1,2</sup><span className=\"super-asterisk\">*</span>\n              </h2>\n              <div className=\"standup-guy-block\">\n                <div>\n                  <img src={imgGuy} alt=\"guy\" />\n                </div>\n                <div className=\"percent-block\">\n                  <p className=\"ninety-four-percent-block\">\n                    <img src={imgNinetyFour} alt=\"Ninety four percent\" />\n                  </p>\n                  <div>\n                    <p className=\"txt-ten-weeks\">\n                      <span>OF MEN MAINTAINED NORMAL LEVELS</span>\n                      <span className=\"bigger\">\n                        FOR 10 FULL WEEKS<sup>1</sup>\n                      </span>\n                    </p>\n                    <p>\n                      After the third AVEED<sup>&reg;</sup> injection, <strong>94%</strong> of\n                      men maintained average testosterone levels within the\n                      normal range for the <strong>full 10 weeks</strong>.\n                      <sup>1&dagger;</sup>{\" \"}\n                    </p>\n                    <strong>\n                      Over the full 10 weeks at steady state<sup>1</sup>:\n                    </strong>\n                    <ul className=\"green\">\n                      <li>\n                        <span>\n                          5.1% of patients had a C<sub>avg</sub> &lt;300 ng/dL\n                        </span>\n                      </li>\n                      <li>\n                        <span>\n                          0.9% of patients had a C<sub>avg</sub> &gt;1000 ng/dL\n                        </span>\n                      </li>\n                    </ul>\n                  </div>\n                </div>\n              </div>\n\n              <p className=\"footnote\">\n                <sup>&dagger;</sup>Normal range was defined as 300–1000 ng/dL.\n              </p>\n            </Col>\n          </Row>\n        </Element>\n        <hr className=\"section-separator\" />\n        <Element name=\"testosterone_levels\">\n          <Row>\n            <Col xs={12}>\n              <p className=\"h1\">\n                Mean Testosterone Levels More Than Doubled vs Baseline\n              </p>\n              <Boxy\n                title=\"Mean serum testosterone concentration at baseline vs mean concentration at steady state (N=117)<sup>1,2</sup><span class='super-asterisk'>*</span>\"\n                className=\"mean-steady-serum-block\"\n              >\n                <img\n                  src={imgSerum}\n                  alt=\"Mean serum testosterone concentration at baseline vs mean concentration at steady state \"\n                  style={{ maxWidth: 400 }}\n                  className=\"expand\"\n                />\n              </Boxy>\n              <div className=\"pt-10\">\n                <strong>\n                  After the third AVEED<sup>&reg;</sup> injection at steady state<sup>1</sup>:\n                </strong>\n                <ul className=\"green\">\n                  <li>\n                    <span>\n                      The average C<sub>max</sub> was 891 ng/dL\n                    </span>\n                  </li>\n                  <li>\n                    <span>\n                      The average C<sub>min</sub> was 324 ng/dL\n                    </span>\n                  </li>\n                </ul>\n              </div>\n            </Col>\n          </Row>\n        </Element>\n        <Element name=\"study_design\">\n          <Row>\n            <Col xs={12}>\n              <div>\n\n                <h2>*STUDY DESIGN<sup>1-3</sup></h2>\n                <p>\n                  This was an 84-week, single-arm, open-label, multicenter\n                  trial of 130 hypogonadal men. All men weighed 65 kg or more\n                  and were 18 years of age or older (mean age 54.2 years).\n                  Patients who had received prior testosterone treatment\n                  completed a washout period and were screened for serum total\n                  testosterone concentrations &lt;300 ng/dL.\n                </p>\n                <p>\n                  In all patients, 750 mg of AVEED<sup>&reg;</sup> was\n                  administered via intramuscular injection at baseline, Week\n                  4, then every 10 weeks thereafter. Blood samples for hormone\n                  concentrations were obtained immediately before each\n                  injection through the eighth injection (ie, 64-week time\n                  point). More frequent samples were drawn for hormones at\n                  Days 4, 7, 11, 14, 21, 28, 42, 56, and 70 after the third\n                  injection. Safety outcomes were followed during an extension\n                  of <nobr>20 weeks—2 more</nobr> injection intervals—through\n                  a total of 84 weeks.{\" \"}\n                </p>\n              </div>\n\n            </Col>\n          </Row>\n        </Element>\n        <Row className=\"callout-blocks-container\">\n          <Col xs={12} md={6}>\n            <HCPSavingsCallout />\n          </Col>\n          <Col xs={12} md={6}>\n            <HCPAdministration />\n          </Col>\n        </Row>\n\n      </div>\n    </HcpPage>\n  );\n};\n\nexport default ClinicalDataPage;\n","module.exports = 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