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NCT02819310 STUDY PROTOCOL An Open Label Study of Chronic Use of BLI400 Laxative in Constipated Adults DOCUMENT DATE: 04/13/2016Confidential Page 1 of 35BLI400 (NDA 211281)ConfidentialBraintree Laboratories,

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Refer to the study protocol template provided by the sponsor or regulatory body.

02

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03

Fill out the study title, objectives, study design, inclusion/exclusion criteria, study endpoints, statistical considerations, and ethical aspects.

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Researchers conducting the clinical trial nct02819310 would need the study protocol to outline the details of the study design, procedures, and objectives.

02

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What is nct02819310 study protocol an?

The nct02819310 study protocol is a document outlining the plans for a specific clinical research study.

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The principal investigator or sponsor of the clinical research study is required to file the nct02819310 study protocol.

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The nct02819310 study protocol can be filled out by providing detailed information about the study design, objectives, methodology, and safety measures.

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The purpose of the nct02819310 study protocol is to provide a roadmap for conducting the clinical research study in a systematic and ethical manner.

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Information such as study objectives, inclusion/exclusion criteria, study endpoints, statistical analyses, and safety monitoring must be reported on the nct02819310 study protocol.

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