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`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00881
`Page 1
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`1/20/2021
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`CIinicaITriaIs.gov Background - CIinicaITriaIs.gov
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`registered and additional trial registration information to be submitted. The law also requires the submission
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`of results for certain trials. This led to the development of theClinicalTrials.gov results database, which
`
`contains summary information on study participants and study outcomes, including adverse events. The
`
`results database was made available to the public in September 2008. FDAAA 801 also established
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`penalties for failing to register or submit the results of trials. In September 2016, HHS issued the Final Rule
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`for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifying and expanding
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`the registration and results information submission requirements of FDAAA 801. This regulation takes effect
`
`in January 2017.
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`An account of the development and expansion of CIinicaITriaIs.gov in response to changes in policies and
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`laws is provided on the History, Policies, and Laws page.
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`Searching CIinicaITriaIs.gov does not require registration or personal identification. Because
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`CIinicaITriaIs.gov is a Government Web site, it does not host or receive funding or advertising from
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`commercial entities or display commercial content.
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`TO TOP
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`What Information Can I Find on CIinicaITriaIs.gov?
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`Each CIinicaITriaIs.gov record presents summary information about a study protocol and includes the
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`following:
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`a Disease or condition
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`.
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`Intervention (for example, the medical product, behavior, or procedure being studied)
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`. Title, description, and design of the study
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`. Requirements for participation (eligibility criteria)
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`. Locations where the study is being conducted
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`0 Contact information for the study locations
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`. Links to relevant information on other health Web sites, such as NLM's MedlinePlus® for patient health
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`information and PubMed® for citations and abstracts of scholarly articles in the field of medicine
`
`Some records also include information on the results of the study, such as:
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`. Description of study participants (the number of participants starting and completing the study and their
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`demographic data)
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`0 Outcomes of the study
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`0 Summary of adverse events experienced by study participants
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`The full history of the changes made to a record can be accessed by viewing the archival version of the
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`https://www.c|inicaltrials.gov/ct2/about-site/background
`
`TO TOP
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`2/3
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`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00881
`Page 2
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00881
`Page 2
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`
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`1/20/2021
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`CIinicaITriaIs.gov Background - CIinicaITriaIs.gov
`
`What Can I Do on This Site?
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`studies; and search studies by topic, country, or region. See the Find Studiessection of the site.
`
`Learn more about clinical research. Find out how clinical studies are conducted and who can
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`participate. See Learn About Studies.
`
`Find and view clinical studies. Conduct basic and advanced searches of clinical study records; browse
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`Manage study records. Find out how to submit and maintain study records, access the Protocol
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`Registration and Results System, and enter summary information about study protocols and results. See
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`the Submit Studies section of the site.
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`Use site tools and data. View statistics on registered studies or download study records for analysis.
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`See the Resources section of the site.
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`This page last reviewed in January 2018
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`https://www.clinicaltrials.gov/ct2/about-site/background
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`3/3
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`Mylan Exhibit 1069
`Mylan v. Regeneron, |PR2021-00881
`Page 3
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`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00881
`Page 3
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