It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. CONSORT 2010 is the current version of the statement and supersedes the 2001 and 1996 versions. The CONSORT Statement comprises a 25-item checklist and a flow diagram. The checklist items focus on reporting how the trial was desi gned, analyzed, and interpreted. The flow diagram displays the progress of all participants through the trial. The checklist and flow diagram are freely available for viewing and downloading at the CONSORT website (http://www.consort-statement.org/consort-2010). The CONSORT Statement is endorsed by general medical journals, specialty medical journals, and leading editorial organizations. CONSORT is part of a broader effort, to im prove the reporting of di fferent types of health research, and indeed, to improve the quality of research used in decision-making in healthcare. CONSORT 2010 Guideline The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is intended to improve the reporting of parallel -group rando mized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. This can only be achieved through co mplete adherence and transparency by authors. CONSORT 2010 was developed through collaboration and consensus between clinical trial methodologists, guideline developers, know ledge translation specialists, and jo urnal editors (see CONSORT group ). CONSORT 2010 is the current version of the guideline and supersedes the 2001 and 1996 versions. CONSORT “Explanation and Elaboration” Document The CONSORT “Explanation and Elaboration” document exp lains and illustrates the principles underlying the CONSORT Statement, and should preferably be used in conjunction with the CONSORT Statement. In addition, extensions of the CONSORT Statement have been developed to give additional guidance for RCTs with specific designs, data and interventions. TheCONSORT website (http://www.consort-statement.org/consort-2010) contains the current definitive version of the CONSORT 2010 Statement and up-to-date information on extensions. Revised Protocol No.: 04 Date: 31-May-2019 202 Approved 5.0 v Approved 1.0 v Clinical Protocol CA021002 BMS-986226 anti-ICOS APPENDIX 9 NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION Heart failure is usually classified according to th e severity of their symptoms. The table below describes the most commonly used classification system, the New York Heart Association (NYHA) Functional Classification. It places patients in one of f our categories based on how much they are limited during physical activity. Class Patient Symptoms INo limi tation of physical activity. Ordinary physical activity does not cause undue fatigue, palpi tation, dyspnea (shortness of breath). IISlight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palp itation, dyspnea (shortness of breath). IIIMarked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpi tation, or dyspnea. IVUnable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. Class Objective Assessment ANo objective evidence of cardiovascular disease. No symptoms and no limitation in ordinary physical activity. BObjective evidence of minimal cardiovascular disease. Mild symptoms and s light limitat ion during ordinary activity. Comfortable at rest. CObjective evidence of moderately se vere cardiovascular disease. Marked limitation in activity due to symptoms, even during less- than-ordinary activity. Comfortable only at rest. DObjective evidence of severe cardiovascular disease. Severe limitations.