Contents Contents 8 Format for protocol submission for approval by Ethics Committee 10 Background 16 Problem statement 16 Rationale of the study 17 Review of literature 17 Study objectives 20 Primary Objectives 20 Secondary objectives 20 Methodology of the study 20 Study design 20 Study Population 20 Setting and location 21 Sample size 21 Inclusion criteria 21 Exclusion criteria 21 Study workflow 21 Perspective 22 Time horizon 22 Discount rate 22 Patient and public involvement 22 Follow-up and outcomes assessed 22 Disease severity 22 Psychological symptoms 23 Life impact 23 Costs incurred shall be calculated at each visit 23 Direct medical costs 23 Indirect costs 23 Statistical analysis 23 Primary objective 23 Cost-effectiveness analysis 24 Cost-utility analysis 24 Willingness-to-pay threshold 25 Cost scenario analysis 25 References 27 Appendix 1: Case Report Form (CRF) 29 Appendix 2: Participant Information Sheet 32 परिशिष्ट 2: प्रतिभागी सूचना पत्रक (आसान भाषा में) 33 Appendix 3: Patient Informed Consent Form 35 परिशिष्ट 3: रोगी सूचित सहमति प्रपत्र 36 prepare me a list like these for these topic Assessment of Clinical Improvement in Cervical Dystonia Following Botulinum Toxin Injection Using the Toronto Western Spasmodic Torticollis Rating Scale-2 (TWSTRS-2)