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The protocol defines administrative and compliance requirements, clarifies sponsor and CTU authorizations, and specifies trial roles and responsibilities. It outlines study background, rationale, objectives, and trial design, including site selection and participant eligibility. The interventions describe treatment arms, accountability, adherence, concomitant care, and overdose/discontinuation processes, while outcomes define primary and secondary endpoints and participant timeline.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":11,"@type":70,"position":76},"https://docshare.wps.com/template/presentations/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/apollo-a-proof-of-concept-study-for-vitamin-a-nasal-drops-in-post-viral-olfactory-loss/163169/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/apollo-a-proof-of-concept-study-for-vitamin-a-nasal-drops-in-post-viral-olfactory-loss/163169.png","ImageObject",442,249,{"name":88,"@type":89},"Eliana","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-29","2026-08-31",true,{"@type":98,"interactionType":99,"userInteractionCount":47},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What is the APOLLO study designed to test?","Question",{"text":108,"@type":109},"APOLLO evaluates vitamin A nasal drops for post-viral olfactory loss (PVOL) as a proof-of-concept intervention.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What key roles and responsibilities are defined in the protocol?",{"text":113,"@type":109},"The protocol assigns authorizations and details roles such as the sponsor, CTU director or representative, trial statistician, and trial team structures including management and steering committees.",{"name":115,"@type":106,"acceptedAnswer":116},"How are interventions and outcomes organized in APOLLO?",{"text":117,"@type":109},"The study defines distinct treatment arms (Arm A and Arm B), including products, treatment schedules, dispensing, and rules for compliance and discontinuation. Outcomes include primary and secondary endpoints with specified assessment methods.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},163169,1788138974,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":8,"category_name":11,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":47,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":125,"read_time":140},4398048949847,"https://ap-avatar.wpscdn.com/avatar/400002536579ef2da7f?_k=1778318612642679267","APOLLO\nA Proof-of-Concept Study for Vitamin A Nasal Drops in Post-Viral Olfactory Loss\nAuthorisation: Chief Investigator\nAuthorisation: Sponsor\nAuthorisation: CTU Director or Representative\nAuthorisation: Trial Statistician\n\u000f\n\u0003Table of Contents\n\u0013 TOC \\o \"1-5\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc65798873\" \u00141\tAdministrative information\t\u0013 PAGEREF _Toc65798873 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798874\" \u00141.1\tCompliance\t\u0013 PAGEREF _Toc65798874 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798875\" \u00141.2\tSponsor\t\u0013 PAGEREF _Toc65798875 \\h \u00141\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798876\" \u00141.3\tStructured trial summary\t\u0013 PAGEREF _Toc65798876 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798877\" \u00141.4\tRoles and responsibilities\t\u0013 PAGEREF _Toc65798877 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798878\" \u00141.4.1\tProtocol contributors\t\u0013 PAGEREF _Toc65798878 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798879\" \u00141.4.2\tRole of trial sponsor and funders\t\u0013 PAGEREF _Toc65798879 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798880\" \u00141.4.3\tTrial Team\t\u0013 PAGEREF _Toc65798880 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798881\" \u00141.4.4\tStudy Management Group\t\u0013 PAGEREF _Toc65798881 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798882\" \u00141.4.5\tIndependent Study Steering Committee\t\u0013 PAGEREF _Toc65798882 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798883\" \u00142\tTrial Diagram\t\u0013 PAGEREF _Toc65798883 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798884\" \u00143\tAbbreviations\t\u0013 PAGEREF _Toc65798884 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798885\" \u00144\tGlossary\t\u0013 PAGEREF _Toc65798885 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798886\" \u00145\tIntroduction\t\u0013 PAGEREF _Toc65798886 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798887\" \u00145.1\tBackground and Rationale\t\u0013 PAGEREF _Toc65798887 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798888\" \u0014The epidemiology and impact of olfactory disorders\t\u0013 PAGEREF _Toc65798888 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798889\" \u0014Current standard of care for PVOL\t\u0013 PAGEREF _Toc65798889 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798890\" \u0014Pathophysiology of olfactory dysfunction and rationale for objective assessments\t\u0013 PAGEREF _Toc65798890 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798891\" \u00145.1.1\tExplanation for choice of comparators\t\u0013 PAGEREF _Toc65798891 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798892\" \u00145.2\tObjectives\t\u0013 PAGEREF _Toc65798892 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798893\" \u00145.3\tTrial Design\t\u0013 PAGEREF _Toc65798893 \\h \u001414\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798894\" \u00146.1\tSite Selection\t\u0013 PAGEREF _Toc65798894 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798895\" \u00146.1.1\tStudy Setting\t\u0013 PAGEREF _Toc65798895 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798896\" \u00146.1.2\tSite/Investigator Eligibility Criteria\t\u0013 PAGEREF _Toc65798896 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798897\" \u00146.1.2.1\tPrincipal Investigator’s (PI) Qualifications and Agreements\t\u0013 PAGEREF _Toc65798897 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798898\" \u00146.1.2.2\tResourcing at site\t\u0013 PAGEREF _Toc65798898 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798899\" \u00146.2\tSite approval and activation\t\u0013 PAGEREF _Toc65798899 \\h \u001415\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798900\" \u00146.3\tParticipants\t\u0013 PAGEREF _Toc65798900 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798901\" \u00146.3.1\tEligibility Criteria\t\u0013 PAGEREF _Toc65798901 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798902\" \u00146.3.1.1\tParticipant selection\t\u0013 PAGEREF _Toc65798902 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798903\" \u00146.3.1.2\tParticipant Inclusion Criteria\t\u0013 PAGEREF _Toc65798903 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798904\" \u00146.3.1.3\tParticipant Exclusion Criteria\t\u0013 PAGEREF _Toc65798904 \\h \u001416\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798905\" \u00146.3.1.5\tCo-enrolment Guidance\t\u0013 PAGEREF _Toc65798905 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798906\" \u00146.3.1.6\tScreening Procedures and Pre-randomisation Investigations\t\u0013 PAGEREF _Toc65798906 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798907\" \u00146.4\tInterventions\t\u0013 PAGEREF _Toc65798907 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798908\" \u00146.4.1\tArm A\t\u0013 PAGEREF _Toc65798908 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798909\" \u00146.4.1.1\tProducts\t\u0013 PAGEREF _Toc65798909 \\h \u001417\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798910\" \u00146.4.1.2\tTreatment Schedule\t\u0013 PAGEREF _Toc65798910 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798911\" \u00146.4.1.3\tDispensing\t\u0013 PAGEREF _Toc65798911 \\h \u001418\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc65798912\" \u00146.4.1.4\tDose Modifications, Interruptions and Discontinuations\t\u0013 PAGEREF _Toc65798912 \\h \u001418\u0015\u0015\n\u0013 HYP","cbCaigpfwEvcYWJI","https://ap.wps.com/l/cbCaigpfwEvcYWJI","docx",901041,54,"English","# Administrative information\n## Compliance\n## Sponsor\n## Structured trial summary\n## Roles and responsibilities\n## Protocol contributors\n## Trial Diagram\n# Introduction\n## Background and Rationale\n## Objectives\n## Trial Design\n# Site and Participant Procedures\n## Site Selection\n## Participants\n# Interventions and Outcomes\n## Interventions\n## Outcomes","[{\"question\":\"What is the APOLLO study designed to test?\",\"answer\":\"APOLLO evaluates vitamin A nasal drops for post-viral olfactory loss (PVOL) as a proof-of-concept intervention.\"},{\"question\":\"What key roles and responsibilities are defined in the protocol?\",\"answer\":\"The protocol assigns authorizations and details roles such as the sponsor, CTU director or representative, trial statistician, and trial team structures including management and steering committees.\"},{\"question\":\"How are interventions and outcomes organized in APOLLO?\",\"answer\":\"The study defines distinct treatment arms (Arm A and Arm B), including products, treatment schedules, dispensing, and rules for compliance and discontinuation. Outcomes include primary and secondary endpoints with specified assessment methods.\"}]","APOLLO - A Proof-of-Concept Study for Vitamin A Nasal Drops in Post-Viral Olfactory Loss | DOCX",19]