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A pivotal phase IIb clinical trial of inhaled alginate oligosaccharide (OligoG) for cystic fibrosis

Deliverables

Web-site launch - project communication

AlgiPharma will establish a Webpage for communication, and sharing progress and results from the H2020-project.

Data Management Plan

A Data Management Plan will be developed in accordance with article 29.3 in the grant agreement. A draft plan will be developed within the first 6 months, and the plan will be updated as the project evolves. Open access to research data will be granted with possible restrictions or embargo periods in order not to jeopardize obligations to protect results or personal data.

First ethics and regulatory approval

After submission of the CTA, the Regulatory- and Ethics authorities will have reviewed the documentation, and the approval can be granted.

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