12. STUDY DESIGN Many of these questions apply to clinical research studies. If any of the items are not applicable to your study, indicate N/A. 12A. Describe the design and methodology (e.g. pre/post design, pilot, study visits, procedures, study intervention). (Max ½ page) 12B. Describe the primary outcome measures/goals of the study. (Max ¼ page) 12C. List any criteria for premature withdrawal of a subject from the study for safety concerns. Not Applicable (Max ¼ page) 12D. Is a placebo used in this study? Yes No If Yes, explain how this is this justified (e.g. no alternative standard treatment available). Include any provisions in place to reduce risks to subjects assigned to placebo (e.g., increased monitoring, rescue medication). (Max ¼ page) 12E. Does this study involve deception or intentional lack of disclosure? Yes No If Yes, justify and indicate how subjects will be debriefed. (Max ¼ page) 12F. Will the subject be withdrawn from or denied usual therapy for any condition in order to participate in the study or be subject to other restrictions during the study? Yes No (This would include medications that are prohibited or restricted in order to be eligible for the study or that may be prohibited or restricted during the course of the study.) If Yes, explain. (Max ¼ page) 13. SUBJECT/CONTROLS 13A. Indicate the main inclusion/exclusion criteria. (Max ¼ page) Indicate the age range of eligible subjects:
12. STUDY DESIGN Many of these questions apply to clinical research studies. If any of the items are not applicable to your study, indicate N/A. 12A. Describe the design and methodology (e.g. pre/post design, pilot, study visits, procedures, study intervention). (Max ½ page) 12B. Describe the primary outcome measures/goals of the study. (Max ¼ page) 12C. List any criteria for premature withdrawal of a subject from the study for safety concerns. Not Applicable (Max ¼ page) 12D. Is a placebo used in this study? Yes No If Yes, explain how this is this justified (e.g. no alternative standard treatment available). Include any provisions in place to reduce risks to subjects assigned to placebo (e.g., increased monitoring, rescue medication). (Max ¼ page) 12E. Does this study involve deception or intentional lack of disclosure? Yes No If Yes, justify and indicate how subjects will be debriefed. (Max ¼ page) 12F. Will the subject be withdrawn from or denied usual therapy for any condition in order to participate in the study or be subject to other restrictions during the study? Yes No (This would include medications that are prohibited or restricted in order to be eligible for the study or that may be prohibited or restricted during the course of the study.) If Yes, explain. (Max ¼ page) 13. SUBJECT/CONTROLS 13A. Indicate the main inclusion/exclusion criteria. (Max ¼ page) Indicate the age range of eligible subjects: