Health Technology Assessment 2012; Vol. 16: No.401 Safety outcomes Health Technology Assessment 2012; Vol. 16: No. 40 ISSN 1366-5278 ISSN 1366-5278 Chapter 4 AbstractDiscussion Main findings ListStrengths of abbreviations and weaknesses Conclusion Executive summary AcknowledgementsBackground ContributionsObjectives of authors TheMethods MENDS study group Interventions ReferencesResults The use of MElatonin in children with Conclusions AppendixTrial registration 1 Neurodevelopmental Disorders and BehaviouralFunding booklet 63 impaired Sleep: a randomised, ChapterAppendix 1 2 SleepIntroduction diary 73 double-blind, placebo-controlled, Background Appendix 3 Rationale parallel study (MENDS) Statistical analysis plan 77 Potential risks and benefits Patient groups for analysis ChapterDescription 2 of safety outcomes AnalysisMethods of primary outcome RE Appleton, AP Jones, C Gamble, AnalysisObjective of secondary outcomes BiochemicalDesign and genetic investigations PR Williamson, L Wiggs, P Montgomery, Participants Appendix 4 Behaviour therapy advice booklet A Sutcliffe, C Barker and P Gringras Details of protocol amendments 87 Interventions Version 7.0 (1 April 2010) Study procedures Version 6.2 (10 July 2009) Data collection tools Version 6.0 (27 January 2009) Treatment-emergent signs and symptoms Version 5.0 (9 July 2008) Seizure diaries Version 4.0 (6 May 2008) Questionnaires Version 3.0 (25 January 2008) Biochemical and genetic investigations Version 2.0 (17 August 2007) Outcomes AppendixSample size 5 calculations ReasonsRandomisation for exclusion and blinding of participants from sleep outcome analyses 91 Data management AppendixStatistical 6 methods SensitivityProtocol amendmentsanalyses and treatment–covariate interactions 95 Treatment–covariate interactions Chapter 3 AppendixResults 7 MeanParticipant change flow from and baseline recruitment plotted against baseline mean total sleep time (TST) forRecruitment each dose rates group Baseline comparability of randomised groups AppendixDescription 8 of dose escalation October 2012 ProtocolUnblinding of randomised treatments 99 10.3310/hta16400 Protocol deviation Health Technology Assessment programme Sleep outcomes Questionnaires Biochemical and genetic investigations Investigation of association between melatonin levels and sleep disorders Health Technology Assessment NIHR HTA programme www.hta.ac.uk HTA

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