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Pergolizzi discloses the following relationships: He serves as consultant, speaker, owner, and\/or researcher for the following companies: Neumentum, Spirify Pharma, Salix, Enalare Therapeutics, Advantx Pharmaceuticals, NEMA Research (he is chief operating officer), Innocan Pharmaceuticals, RTU Pharmaceuticals (he is director), and Bridge Therapeutics. He is Chief Executive Officer, Head of Research and Development, and Chairman of the Board for Neumentum. Amanjot Battra discloses that she is an employee of Neumentum. William K. Schmidt is associated with NorthStar Consulting and is a consultant for Neumentum.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of Interest"}},{"value":"Protocols were approved by the IntegReview institutional review board in Austin, Texas. The study protocol is NTM-001-HP001. All patients signed informed consent before entry into the study. The study complied with the Good Clinical Practice requirements described in the current International Council for Harmonization (ICH) guidelines and current federal regulations. This study was not registered with ClinicalTrials.gov. This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}