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2005. Section 1: Recommendations for amendments or alterations to the Operating Papers shall be presented at special meetings of the Committee. Approval requires a majority vote of the Committee membership. The Chair may vote on operating paper amendments. I understand and agree that, in connection with the performance of my duties as a member of the Misconduct in Science Committee of Southern Illinois University School of Medicine, I will be engaged in activities of a confidential nature, including but not limited to, reviewing, investigating, and reporting misconduct in science at Southern Illinois University School of Medicine. I further understand that, in this capacity, I will be expected to receive and/or become privy to information of a confidential nature, including but not limited to, records, documents, research reports and related research documents and statistics which go to the issue of misconduct in science and other information of a confidential nature. I further understand that I will be called upon to evaluate such information, in part, by the application of laws, regulations and policies. I understand that my position as a member of this committee is one which demands the highest trust, and that policies and procedures, as well as, in some instances, specific statutes, regulations and governmental policies, protect the confidentiality of certain records and information which I will review by prohibiting their disclosure in any manner. In addition to any duty of confidentiality or nondisclosure imposed on me by specific statutes, regulations and governmental policies, I agree to keep secret, and not disclose to others nor make any personal use of whatsoever, either during my service on said subcommittee or at any time thereafter, of any said confidential information, and to hold any such documents and/or information, regardless of nature in strictest confidence. I understand that any violation of this confidentiality statement will subject me to disciplinary action, up to and including removal from this subcommittee and/or discharge. I further understand that my duty to maintain the information in confidence imposed hereunder shall survive my resignation or termination from this subcommittee.


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A 2 part statistical analysis plan specified: part 1, a descriptive analysis of 3 recent HABP/VABP studies to understand potential endpoints and analysis populations; and part 2, a definitive analysis of the 5 datasets that allowed the most detailed analyses . The FDA generously shared hypothesis generating analyses . Datasets are identified in the references . Although some studies employed the terminology hospital acquired pneumonia and ventilator associated pneumonia, we employ the FDA terminology HABP and VABP . We defined HABP as nonventilated or mechanically ventilated ie, intubated, including tracheostomy patients, and mechanically ventilated at randomization. Part 1 studies enrolled both HABP and VABP patients: 1 telavancin ATTAIN Study 0015 ; 2 telavancin assessment of telavancin for treatment of hospital acquired pneumonia ATTAIN Study 0019 Theravance Biopharma, Inc; 3 tigecycline Pfizer Study 311 Pfizer, Inc Part 2 utilized the following datasets: 1 Pfizer Study 311; 2 doripenem VABP Study 08, Dori 08 ; 3 doripenem HABP/early VABP Study 09, Dori 09 ; 4 doripenem VABP Study 10, Dori 10 all Shionogi, Inc; 5 prospective, observational intensive care unit study non industry sponsored study Servei de Pneumologia, Hospital Clinic, Institut d'Investigacions Biomdiques August Pi i Sunyer, Centro de investigacin Biomdica en Red en Enfermedades Respiratorias, Universitat de Barcelona, Spain. This first step evaluated whether the datasets included patient demographics; predictor/risk variables for ACM eg, acute physiology and chronic health evaluation APACHE II score; evolution of pneumonia signs and oxygenation fractional inspired oxgen FiO2/arterial oxygen tension PaO2 during treatment; pneumonia symptom improvement over time; ACM rates; and adverse events AEs that could form a mortality plus ACM+ endpoint a composite endpoint of ACM plus selected AEs reflecting how a patient feels or functions. A focused literature review identified predictors of ACM in HABP/VABP patients . Part 2 objectives were to determine ACM incidence during days 1428; baseline characteristics associated with higher ACM rates; incidence and types of AEs/serious AEs SAEs relevant to an ACM+ endpoint; potential utility of a symptom based endpoint in nv HABP; impact of prior antibiotic therapy on outcome; impact of adjunctive systemic antibiotic therapy on outcome; and utility of Gram stain of respiratory secretions for predicting microbiologically confirmed infection not performed due to absence of data. The primary analysis populations were the all treated AT, ie, ITT patients receiving any study drug and microbiological AT micro AT; ie, AT with a pathogen isolated from respiratory secretions and/or blood. Analyses were conducted for nv HABP, v HABP, and VABP.

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