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NCT02706483An OpenTable, Longer Safety and Tolerability Study of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (BSC) Sponsor:Synergy Pharmaceuticals Inc. 420 Lexington Avenue,
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An open label long refers to a type of clinical trial design where both the researchers and participants are aware of the treatment being administered. It typically involves an ongoing study that does not have a placebo or control group.
Researchers, sponsors, or organizations conducting clinical trials that utilize an open label long design are required to file the necessary documentation.
To fill out an open label long, ensure that all required fields are completed, including details about the trial design, participant demographics, treatment protocols, and any outcome measures observed.
The purpose of an open label long is to collect real-world efficacy and safety data while allowing both participants and researchers to understand the treatment being given, thereby facilitating transparent monitoring and reporting.
Information that must be reported includes the trial title, participants' demographics, treatment details, adverse events, study results, and any changes to trial protocol.
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