Contents

• 2. SYNOPSIS
• 4. GLOSSARY OF ABBREVIATIONS AND TERMS
• 5. ETHICS
  • 5.1. Institutional Review Board
  • 5.2. Ethical Conduct of the Study
  • 5.3. Participant Information, Consent, and Assent
• 6. INVESTIGATOR AND STUDY ADMINISTRATIVE STRUCTURE
  • 6.1. Principal Investigator
  • 6.2. Administrative Structure
• 7. INTRODUCTION
  • Pharmacodynamics Endpoint
  • 7.1. Data Sources for This Report
  • 7.2. Structure for this Clinical Study Report
• 8. STUDY OBJECTIVES
• 9. INVESTIGATIONAL PLAN
  • 9.1. Overall Design and Plan Description
  • 9.2. Discussion of Study Design and Choice of Control Groups
  • 9.3. Selection of Study Population
  • 9.4. Treatments
  • 9.5. Efficacy and Safety Variables
  • 9.6. Data Quality Assurance
  • 9.7. Statistical Methods and Determination of Sample Size
  • 9.8. Changes in the Conduct of the Study or the Planned Analyses
• 10. STUDY PARTICIPANTS
  • 10.1. Disposition of Participants – Pediatrix Medical Group Database
  • 10.2. Disposition of Participants – Medical Chart Review
• 11. EFFICACY EVALUATION
• 12. SAFETY EVALUATION
  • 12.1. Pediatrix Administrative Database Safety Analysis
  • 12.2. Medical Chart Review
  • 12.3. Safety Conclusions
• 13. DISCUSSION AND OVERALL CONCLUSIONS
  • 13.1. Overall Conclusions
• 14. TABLES, FIGURES, AND GRAPHS REFERRED TO BUT NOT INCLUDED IN THE TEXT
  • 14.1. Demographic Data
  • 14.2. Safety Data
  • 14.3. Dosing Data
• 15. REFERENCE LIST
• 16. APPENDICES
• Descriptive Supplementary Documents

Study data is available on the DASH repository at https://dash.nichd.nih.gov/study/15895

This study was conducted in compliance with Good Clinical Practices (GCP) as outlined in the International Conference on Harmonization (ICH), including the archiving of essential documents. All unpublished information contained within this report is confidential and the sole property of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).