ࡱ> y gbjbj 4b{{8R 4fB$D ////0~NDI$H L00LL //4 WWWLB//WLWWfv+ݱ/P % MHѴ60fOݱݱWLLL SLLLfLLLLLLLLLLLLL :  [The highlighted text is for instruction only and should be deleted. Other texts should be included if appropriate for the trial.] Study Title: Protocol Number:use R&D number EudraCT Number: Protocol Version:(The version submitted to the MHRA and Ethics should be called Version 1.0 ) Short title or acronym: Chief Investigator:Insert name and contact details, including institutional affiliationsInvestigators:Insert names of key collaborators, including institutional affiliationsFunder:Insert details of organisation providing fundingPlease declare any/no potential conflicts of interest Sponsor Great Ormond Street Hospital for Children NHS Foundation Trust Joint R&D Office GOSH/ICH based at UCL Institute of Child Health 30 Guilford Street London WC1N 1EH United Kingdom Clinical Trials Manager T: +44 207 905 2346 F: +44 207 905 2201 HYPERLmailto:vincent.grek@o4cp.com"vincent.grek@o4cp.comE: Sponsor Medical Expert: Name and Address - if applicable Medical Contact on site: 24/7 emergency contact details should be included Signatures The Chief Investigator, Principal Investigators and Sponsor have discussed this protocol. All have agreed to perform the investigation as written and to abide by this protocol except in case of medical emergency or where departures from it are mutually agreed in writing. Chief Investigator ___________________________________ Signature Date: Sponsor Great Ormond Street Hospital for Children NHS Foundation Trust Clinical Trials Manager Joint R&D Office ___________________________________ Signature Date: Participating Sites and Local Principal Investigators (PI) Data Monitoring Committee/Trial Steering Committee (if any) Amendment History Amendment No.Protocol Version No.Date issuedAuthor(s) of changesDetails of Changes made List details of all protocol amendments here whenever a new version of the protocol is produced. Protocol amendments must be submitted to the Sponsor for approval prior to submission to the REC committee or MHRA. ABBREVIATIONS Define all unusual or technical terms related to the trial. Add or delete as appropriate to your trial. Maintain alphabetical order for ease of reference. AEAdverse eventAR Adverse reactionALTAlanine TransaminaseCIChief InvestigatorCRAClinical Research Associate (Monitor)CRFCase Report FormCRO Contract Research OrganisationCTClinical TrialsCTAClinical Trials AuthorisationDMC/DMSCData Monitoring Committee / Data Monitoring and Safety CommitteeDSURDevelopment Safety Update ReportEMEAEuropean Medicines AgencyEudraCTEuropean Clinical Trials DatabaseGCPGood Clinical PracticeGOSHGreat Ormond Street Hospital GPGeneral PractitionerGTACGene Therapy Advisory CommitteeIBInvestigators BrochureICFInformed Consent FormISFInvestigator Site FileICHInternational Conference of HarmonisationIMPInvestigational Medicinal ProductIRBIndependent Review BoardMHRAMedicines and Healthcare products Regulatory AgencyNHSNational Health ServiceNRESNational Research Ethics Service PIPrincipal InvestigatorPILParticipant/ Patient Information LeafletQPQualified Person for release of trial drugR&DNHS Trust R&D DepartmentRECResearch Ethics CommitteeSAESerious Adverse EventSARSerious Adverse ReactionSDVSource Data VerificationSMPCSummary of Medicinal Product CharacteristicsSOPStandard Operating ProcedureSUSARSuspected Unexpected Serious Adverse ReactionsTMFTrial Master FileTMGTrial Management GroupTSCTrial Steering CommitteeUCLUniversity College London Study Synopsis Title of clinical trialSponsor nameEudract number for proposed trialMedical condition or disease under investigationPurpose of clinical trial Primary objectiveSecondary objective (s)Study Design Study EndpointsSample SizeSummary of eligibility criteriaInvestigational medicinal product and dosageActive comparator product(s)Route(s) of administration Maximum duration of treatment of a subjectProcedures: Screening & enrolment Baseline Treatment period End of StudyProcedures for safety monitoring during trialDefinition of end of trial Table of Contents  TOC \o "1-2" \h \z \u  HYPERLINK \l "_Toc377025500" Sponsor  PAGEREF _Toc377025500 \h 1  HYPERLINK \l "_Toc377025501" Participating Sites and Local Principal Investigators (PI)  PAGEREF _Toc377025501 \h 3  HYPERLINK \l "_Toc377025502" 1 Amendment History  PAGEREF _Toc377025502 \h 3  HYPERLINK \l "_Toc377025503" 3 Study Synopsis  PAGEREF _Toc377025503 \h 5  HYPERLINK \l "_Toc377025504" Table of Contents  PAGEREF _Toc377025504 \h 6  HYPERLINK \l "_Toc377025505" 4 Introduction  PAGEREF _Toc377025505 \h 8  HYPERLINK \l "_Toc377025506" 4.1 Background  PAGEREF _Toc377025506 \h 8  HYPERLINK \l "_Toc377025507" 4.3 Data from non-clinical studies  PAGEREF _Toc377025507 \h 8  HYPERLINK \l "_Toc377025508" 4.4 Clinical Data  PAGEREF _Toc377025508 \h 8  HYPERLINK \l "_Toc377025509" 5 Study rationale and purpose  PAGEREF _Toc377025509 \h 8  HYPERLINK \l "_Toc377025510" 5.3 Rationale for choice of comparator drug  PAGEREF _Toc377025510 \h 8  HYPERLINK \l "_Toc377025511" 6 Trial objective and purpose  PAGEREF _Toc377025511 \h 9  HYPERLINK \l "_Toc377025512" 7 Assessment and Management of Risk  PAGEREF _Toc377025512 \h 9  HYPERLINK \l "_Toc377025513" 7 Trial Design  PAGEREF _Toc377025513 \h 9  HYPERLINK \l "_Toc377025514" 7.1 Description of study design  PAGEREF _Toc377025514 \h 9  HYPERLINK \l "_Toc377025515" 8 Population  PAGEREF _Toc377025515 \h 9  HYPERLINK \l "_Toc377025516" 8.1 Inclusion Criteria  PAGEREF _Toc377025516 \h 10  HYPERLINK \l "_Toc377025517" 8.2 Exclusion Criteria  PAGEREF _Toc377025517 \h 10  HYPERLINK \l "_Toc377025518" 9 Trial Procedures  PAGEREF _Toc377025518 \h 10  HYPERLINK \l "_Toc377025519" 9.1 Recruitment  PAGEREF _Toc377025519 \h 10  HYPERLINK \l "_Toc377025520" 9.2 Informed Consent  PAGEREF _Toc377025520 \h 10  HYPERLINK \l "_Toc377025521" 9.3 Screening and Eligibility Assessment  PAGEREF _Toc377025521 \h 10  HYPERLINK \l "_Toc377025522" 9.4 Baseline Assessments  PAGEREF _Toc377025522 \h 11  HYPERLINK \l "_Toc377025523" 9.5 Subsequent Visits  PAGEREF _Toc377025523 \h 11  HYPERLINK \l "_Toc377025524" 9.6 Treatment Duration  PAGEREF _Toc377025524 \h 11  HYPERLINK \l "_Toc377025525" 9.7 Post Treatment Follow Up  PAGEREF _Toc377025525 \h 11  HYPERLINK \l "_Toc377025526" 9.8 Discontinuation/Withdrawal of Participants from Trial Treatment  PAGEREF _Toc377025526 \h 11  HYPERLINK \l "_Toc377025527" 9.9 Definition of End of Trial  PAGEREF _Toc377025527 \h 11  HYPERLINK \l "_Toc377025528" 10 Treatment Regimens  PAGEREF _Toc377025528 \h 11  HYPERLINK \l "_Toc377025529" 10.1 Name and description of investigational medicinal product(s)  PAGEREF _Toc377025529 \h 12  HYPERLINK \l "_Toc377025530" 10.2 Dosage schedules  PAGEREF _Toc377025530 \h 12  HYPERLINK \l "_Toc377025531" 10.3 Route of Administration  PAGEREF _Toc377025531 \h 12  HYPERLINK \l "_Toc377025532" 10.4 Maximum dosage allowed  PAGEREF _Toc377025532 \h 12  HYPERLINK \l "_Toc377025533" 10.5 Maximum duration of treatment of a subject  PAGEREF _Toc377025533 \h 12  HYPERLINK \l "_Toc377025534" 10.6 Active comparator products  PAGEREF _Toc377025534 \h 12  HYPERLINK \l "_Toc377025535" 10.7 Dosage modifications  PAGEREF _Toc377025535 \h 12  HYPERLINK \l "_Toc377025536" 10.8 Presentation of the drug  PAGEREF _Toc377025536 \h 12  HYPERLINK \l "_Toc377025537" 10.9 Known Drug reactions  PAGEREF _Toc377025537 \h 12  HYPERLINK \l "_Toc377025538" 10.10 Drug storage and supply  PAGEREF _Toc377025538 \h 12  HYPERLINK \l "_Toc377025540" 10.11 Compliance with Trial Treatment  PAGEREF _Toc377025540 \h 12  HYPERLINK \l "_Toc377025541" 10.12 Concomitant therapy  PAGEREF _Toc377025541 \h 13  HYPERLINK \l "_Toc377025542" 10.13 Post-trial Treatment  PAGEREF _Toc377025542 \h 13  HYPERLINK \l "_Toc377025543" 11 Randomisation, Blinding and Code-breaking  PAGEREF _Toc377025543 \h 13  HYPERLINK \l "_Toc377025544" 11.1 Method of Unblinding  PAGEREF _Toc377025544 \h 13  HYPERLINK \l "_Toc377025545" 11.2 Subject Withdrawal Criteria  PAGEREF _Toc377025545 \h 14  HYPERLINK \l "_Toc377025546" 12 Assessment of Safety (Keep this section!!!)  PAGEREF _Toc377025546 \h 14  HYPERLINK \l "_Toc377025547" 12.1 Definitions  PAGEREF _Toc377025547 \h 14  HYPERLINK \l "_Toc377025548" 12.1.5 Suspected Unexpected Serious Adverse Reaction (SUSAR)  PAGEREF _Toc377025548 \h 15  HYPERLINK \l "_Toc377025549" 12.6 Expected Adverse Drug Reactions  PAGEREF _Toc377025549 \h 15  HYPERLINK \l "_Toc377025550" 12.7 Expected Serious Adverse Events  PAGEREF _Toc377025550 \h 15  HYPERLINK \l "_Toc377025551" 12.8 Recording and evaluation of adverse events  PAGEREF _Toc377025551 \h 15  HYPERLINK \l "_Toc377025552" 12.9 Reporting Procedures for Serious Adverse Events  PAGEREF _Toc377025552 \h 16  HYPERLINK \l "_Toc377025553" 12.10 Reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs)  PAGEREF _Toc377025553 \h 17  HYPERLINK \l "_Toc377025554" 12.11 Development Safety Update Reports  PAGEREF _Toc377025554 \h 18  HYPERLINK \l "_Toc377025555" 13 Statistics  PAGEREF _Toc377025555 \h 18  HYPERLINK \l "_Toc377025556" 13.1 Statistical methods to be employed (plan of analysis)  PAGEREF _Toc377025556 \h 18  HYPERLINK \l "_Toc377025557" 13.2 Number of Subjects to be enrolled  PAGEREF _Toc377025557 \h 18  HYPERLINK \l "_Toc377025558" 13.3 Interim analyses  PAGEREF _Toc377025558 \h 18  HYPERLINK \l "_Toc377025559" 13.4 Criteria for the termination of the trial  PAGEREF _Toc377025559 \h 18  HYPERLINK \l "_Toc377025560" 13.5 Procedure to account for missing or spurious data  PAGEREF _Toc377025560 \h 18  HYPERLINK \l "_Toc377025561" 13.6 Inclusion in Analysis  PAGEREF _Toc377025561 \h 18  HYPERLINK \l "_Toc377025562" 14 Data Management  PAGEREF _Toc377025562 \h 19  HYPERLINK \l "_Toc377025563" 14.1 Source Documents  PAGEREF _Toc377025563 \h 19  HYPERLINK \l "_Toc377025564" 14.2 Direct Access to source data / documents  PAGEREF _Toc377025564 \h 19  HYPERLINK \l "_Toc377025565" 14.3 Data Recording and Record Keeping  PAGEREF _Toc377025565 \h 19  HYPERLINK \l "_Toc377025566" 15 Oversight Committees involved in trial  PAGEREF _Toc377025566 \h 20  HYPERLINK \l "_Toc377025567" 16 Quality Control (Monitoring) and Quality Assurance (Audit)  PAGEREF _Toc377025567 \h 20  HYPERLINK \l "_Toc377025568" 17 Ethical and Regulatory Approvals  PAGEREF _Toc377025568 \h 20  HYPERLINK \l "_Toc377025569" 17.1 Ethical Approval  PAGEREF _Toc377025569 \h 20  HYPERLINK \l "_Toc377025570" 17.2 Regulatory Approval  PAGEREF _Toc377025570 \h 20  HYPERLINK \l "_Toc377025571" 18 Patient Confidentiality & Data Protection  PAGEREF _Toc377025571 \h 21  HYPERLINK \l "_Toc377025572" 19 Serious Breaches  PAGEREF _Toc377025572 \h 21  HYPERLINK \l "_Toc377025573" 20 Financial Information and Insurance  PAGEREF _Toc377025573 \h 21  HYPERLINK \l "_Toc377025574" 21 Publications Policy  PAGEREF _Toc377025574 \h 21  HYPERLINK \l "_Toc377025575" 22 References  PAGEREF _Toc377025575 \h 22  HYPERLINK \l "_Toc377025576" 23 Appendix A: Trial Flow Chart  PAGEREF _Toc377025576 \h 22  HYPERLINK \l "_Toc377025577" 24 Appendix B: Schedule of Procedures  PAGEREF _Toc377025577 \h 22  Introduction Background The following should be included; Summary of the main characteristics of the disease being studied Description of the population to be studied. References to literature and data that are relevant to the trial and that provide background for the trial. For early phase studies, clearly state the no of patients who have received the IMP(s). 3.2 Introduction to investigational treatment(s) and other study treatment(s) Name, description and characteristics of the investigational medicinal product(s) Data from non-clinical studies A summary of findings from pre/non-clinical studies (if relevant) that potentially have clinical significance to this trial. Clinical Data Summary of the known and potential risks and benefits, if any, to human participants from other clinical trials Efficacy Safety and tolerability Pharmacokinetics & pharmacodynamics Study rationale and purpose Include the rationale for the research question needs to be studied. Brief description of justification for, the route of administration, dosage, dosage regimen, and treatment period. 4. 1 Rationale for the study design 4.2 Rationale for dose and regimen selection Rationale for choice of comparator drug Trial objective and purpose ObjectivesOutcome Measures/Endpoints Primary Objective The endpoints/outcome measures should reflect the objectives. It is important that only one primary endpoint/outcome measure is selected as it will be used to decide the overall results of the trial. The primary endpoint/outcome measure should be measurable, clinically relevant to participants and widely accepted by the scientific and medical community. Assessments of endpoints/outcome measures should be described in detail in section 8.Secondary Objectives As aboveAssessment and Management of Risk Explain the risks and how high is the risk compared to normal standard practice and how will risk be minimised? Consider the starting dose, dose increments, administration of doses, resources available particularly in terms of facilities and staff, procedures, type of patients, staff training required. Please refer to the following documentation to prepare this section:  HYPERLINK "http://www.mhra.gov.uk/home/groups/l-ctu/documents/websiteresources/con111784.pdf" http://www.mhra.gov.uk/home/groups/l-ctu/documents/websiteresources/con111784.pdf Trial Design Description of study design Briefly describe the overall trial design e.g. double-blind, placebo-controlled, parallel design, open labelled, observational. Avoid repetition as further details will be given in later sections. Add the number of total number of centres here Population Give an overall description of the trial participants. Describe the medical condition, severity and < that are observed by the Investigator or reported by the participant, will be recorded on the CRF, whether or not attributed to trial medication) Individual adverse events should be evaluated by the investigator and, This includes the evaluation of its seriousness and the causality between the investigational medicinal product(s) and/or concomitant therapy and the adverse event. Reporting Procedures for Serious Adverse Events All SAEs (other than those defined in the protocol as not requiring reporting) must be reported on the SAE reporting form to R&D within 24 hours of the Site Study Team becoming aware of the event. The event will be recorded in the sponsors SAE form (F44) and emailed to  HYPERLINK "mailto:CTIMP.safety@gosh.nhs.uk" CTIMP.safety@gosh.nhs.uk or faxed to the Joint R&D office (0207 905 2201) within the reporting timelines. R&D will perform an initial check of the report, request any additional information if required. Additional and further requested information (follow-up or corrections to the original case) will be detailed on a new SAE Report Form and faxed/emailed to R&D. Insert appropriate time period during which SAEs will be recorded. For example, from taking of Informed Consent to 30 days following last administration of IMP. This depends on the IMP Explain if there is any foreseeable and predefined SAEs do not need to be reported immediately, e.g. if hospital admission/death is expected in the underlying condition, and this has been stated in the protocol. Assessment of seriousness Mild: The subject is aware of the event or symptom, but the event or symptom is easily tolerated Moderate: The subject experiences sufficient discomfort to interfere with or reduce his or her usual level of activity Severe: Significant impairment of functioning; the subject is unable to carry out usual activities and / or the subjects life is at risk from the event. Assessment of causality Probable: A causal relationship is clinically / biologically highly plausible and there is a plausible time sequence between onset of the AE and administration of the investigational medicinal product and there is a reasonable response on withdrawal. Possible: A causal relationship is clinically / biologically plausible and there is a plausible time sequence between onset of the AE and administration of the investigational medicinal product. Unlikely: A causal relation is improbable and another documented cause of the AE is most plausible. Unrelated: A causal relationship can be definitely excluded and another documented cause of the AE is most plausible. 12.8.3 Expectedness Expectedness will be determined according to the Investigators Brochure/Summary of Product Characteristics. (delete as appropriate) An adverse reaction, the nature, or severity of which is not consistent with the applicable product information (e.g. investigator's brochure for an unapproved investigational product or summary of product characteristics (SmPC) for an authorised product). When the outcome of the adverse reaction is not consistent with the applicable product information this adverse reaction should be considered as unexpected. Reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) All suspected adverse reactions related to an investigational medicinal product (the tested IMP and comparators) which occur in the concerned trial, and that are both unexpected and serious (SUSARs) are subject to expedited reporting. Who should report and whom to report to? The sponsor should report all the relevant safety information previously described to the concerned competent authorities and to the Ethics Committee concerned. The sponsor shall inform all investigators concerned of relevant information about SUSARs that could adversely affect the safety of subjects. When to report? Fatal or life-threatening SUSARs The MHRA and the Research Ethics Committee should be notified as soon as possible but no later than 7 calendar days after the sponsor has first knowledge of the minimum criteria for expedited reporting. In each case relevant follow-up information should be sought and a report completed as soon as possible. It should be communicated to the MHRA and the Ethics Committee within an additional eight calendar days. Non-fatal and non-life threatening SUSARs All other SUSARs and safety issues must be reported to the competent authority and the Ethics Committee in the concerned Member States as soon as possible but no later than 15 calendar days after the sponsor has first knowledge of the minimum criteria for expedited reporting. Further relevant follow-up information should be given as soon as possible. Follow-up reports of SUSARs In case of incomplete information at the time of initial reporting, all the appropriate information for an adequate analysis of causality should be actively sought from the reporter or other available sources. The sponsor should report further relevant information after receipt as follow-up reports. In certain cases, it may be appropriate to conduct follow-up of the long-term outcome of a particular reaction. Development Safety Update Reports The sponsor will submit (in addition to the expedited reporting above) DSUR once a year throughout the clinical trial, or on request, to the Competent Authority (MHRA in the UK), Ethics Committee and the Host NHS Trust(if applicable) Statistics Statistical methods to be employed (plan of analysis) Number of Subjects to be enrolled Reason for choice of sample size, including reflections on the power of the trial and clinical justification. Interim analyses Include timing etc Criteria for the termination of the trial Procedure to account for missing or spurious data Procedure for reporting deviations from original statistical plan Selection of subjects to be included in the analyses (eg all randomised subjects, all dosed subjects, all eligible subjects, evaluable subject; analysis on the basis of intention to treat or actually treated; etc..)s) Inclusion in Analysis Describe the selection of subjects to be included in the analyses (e.g. all randomised participants, all dosed participants, all eligible participants, and evaluable participants). 13.7 Procedures for Reporting any Deviation(s) from the Original Statistical Plan Detail procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the original statistical plan should be described and justified in protocol and/or in the final report, as appropriate). Data Management Source Documents Source documents are original documents, data, and records from which participants CRF data are obtained. These include, but are not limited to, hospital records (from which medical history and previous and concurrent medication may be summarised into the CRF), clinical and office charts, laboratory and pharmacy records, diaries, microfiches, radiographs, and correspondence. All documents will be stored safely in confidential conditions. On all study-specific documents, other than the signed consent, the participant will be referred to by the study participant number/code, not by name Direct Access to source data / documents Only members of the trial research team and authorised representatives from the sponsor will have direct access to the source data and trial documentation. All source data and trial documentation will also be available to external auditors if and when required, and inspectors in the event of regulatory inspection. Access to the final data set will remain with the chief investigator Data Recording and Record Keeping Describe method(s) of data collection, entry and management, including details of data management tools, for example CRF software, etc. Describe where, and for how long, data will be retained The participants will be identified by a unique trial specific number and/or code in any database. The name and any other identifying detail will NOT be included in any trial data electronic file. Archiving Archiving will be authorised by the Sponsor following submission of the end of study report. Essential documents will be retained for a minimum of 25 years after completion of the trial. These documents will be retained for longer if required by the applicable regulatory requirements. For Advanced Therapy Medicinal Products: Records related to traceability of the IMP at site along with the patient identifiers will be retained at site for at least 30 years after the expiry date of the product or longer if required by the clinical trial authorisation. This will include the relevant documentation contained in the sponsor and investigator files as well as the trial subjects medical records. Oversight Committees involved in trial There may be occasions when trial management committees or data monitoring board forms part of the oversight of the trial management. For example; Trial Management Group (TMG) , Data Monitoring Committee (DMC) and Trial Steering Group (TSC). Please insert any applicable committees and their remits. The terms of reference for these committees will need to be provided in separate documents 15.1 Data Monitoring Committee (DMC) This study will use an External Data Monitoring Committee (E-DMC). The DMC will be responsible for on-going monitoring of the efficacy and safety of subjects in the study according to the Charter. The recommendations made by the DMC to alter the conduct of the study will be forwarded to the Sponsor for final a decision. The Sponsor will forward such decisions to regulatory authorities, as appropriate. The DMC will be independent of the study team and will have no direct involvement in other aspects of the trial. The DMC will develop its own operation procedures in consultation with the sponsor which will be documented in the DMC charter. Quality Control (Monitoring) and Quality Assurance (Audit) The Sponsor is responsible for implementing Quality Control and Quality Assurance. The study will be conducted in accordance with the current approved protocol, ICH GCP, relevant regulations and standard operating procedures. A Trial specific monitoring plan will be established and the trial will be monitored with the agreed plan. Issues will be escalated to the Chief Investigator and Sponsor. Ethical and Regulatory Approvals Ethical Approval The Investigator will ensure that this trial is conducted in accordance with the principles of the Declaration of Helsinki, ICH Good Clinical Practice Guidelines and in accordance with the terms and conditions of the ethical approval given to the trial. A favourable opinion will be sought from the Research Ethics Committee before recruitment begins. Regulatory Approval A Clinical Trial Authorisation (CTA) will be sought from the MHRA before recruitment begins. The trial will be conducted at approved trial sites in accordance with the trial protocol and the terms of the CTA granted by the MHRA. Patient Confidentiality & Data Protection Patient identifiable data, including initials, date of birth and NHS number will be required for the registration process. The trial staff will ensure that the participants anonymity is maintained. The participants will be identified only by initials and a participants ID number on the CRF and any electronic database. All documents will be stored securely and only accessible by trial staff and authorised personnel. The trial will comply with the Data Protection Act, which requires data to be anonymised as soon as it is practical to do so. Data will be stored in a secure manner and in accordance with the Data Protection Act 1998. Serious Breaches The Medicines for Human Use (Clinical Trials) Regulations contain a requirement for the notification of "serious breaches" to the MHRA within 7 days of the sponsor becoming aware of the breach. A serious breach is defined as A breach of GCP or the trial protocol which is likely to effect to a significant degree (a) the safety or physical or mental integrity of the subjects of the trial; or (b) the scientific value of the trial. In the event that a serious breach is suspected GOSH R&D must be contacted as soon as possible. GOSH R&D will notify the regulatory authority according to the SOP on Serious Breach Notification Financial Information and Insurance A statement of the finance for the trial such as details of funding body Cover for negligent harm will be provided by the Great Ormond Street Hospital for Children NHS Foundation Trust through the Clinical Negligent Scheme for Trusts (CNST). No-fault compensation insurance cover for any non-negligent harm will be provided by University College London (UCL). Publications Policy All individuals who have made substantial intellectual, scientific and practical contributions to the trial and the manuscript should, where possible, be credited as authors; all individuals credited as authors should deserve that designation. It is the responsibility of the Chief Investigator and co-PI and, ultimately, the Sponsors to ensure that these principles are upheld. The status of manuscripts in preparation will be reviewed by the chief Investigator and sponsor if requires. In all cases where journal policies permit, all investigators who contribute patients to the trial will be acknowledged. The results of the study will be reported and disseminated as follows; Peer reviewed scientific journals; Internal report, plus possible article on Institute web pages (publicly accessible); Conference presentation(s); Written feedback to patient support groups. References Appendix A: Trial Flow Chart Optional Appendix B: Schedule of Procedures Optional Alter as required, delete if not wanted ProceduresVisits (insert visit numbers as appropriate)ScreeningBaselineInformed consentDemographicsMedical historyConcomitant medicationsPhysical examinationECGLaboratory testsEligibility assessmentRandomisationDispensing of trial drugsDrug AccountabilityAssessment/Visit 1 (describe)Assessment/Visit 2 (describe)Assessment/Visit 3 (describe)Assessment/Visit 4 (describe)Adverse event assessments       PAGE \* MERGEFORMAT 13 Protocol Short title Version Number: . 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