Statistical Analysis Plan: IT001-302 Study Title: A prospective, Phase 3, randomized, multi-center, double-blind, double dummy study of the efficacy, tolerability and safety of intravenous sulopenem followed by oral sulopenem-etzadroxil with probenecid versus intravenous ertapenem followed by oral ciprofloxacin or amoxicillin-clavulanate for treatment of complicated urinary tract infections in adults. Study Number: IT001-302 Study Phase: Phase 3 Product Name: Sulopenem (CP-70,429), Sulopenem-etzadroxil (PF-03709270)/Probenecid Indication: Complicated urinary tract infection Study Statistician: Michael Zelasky Study Clinician: Steven I. Aronin, M.D. Sponsor: Iterum Therapeutics International Limited 20 Research Parkway, Suite A Old Saybrook, CT 06475 Final SAP Date: September 25, 2019 Revised SAP Date: February 11, 2020 Protocol Version: January 16, 2020 Confidentiality Statement This document is strictly confidential. It was developed by Iterum Therapeutics US Limited should not be disclosed to a third party, with the exception of regulatory agencies and study audit personnel. Reproduction, modification or adaptation, in part or in total, is strictly forbidden without prior written approval by Iterum Therapeutics US Limited Digitally signed by Anita F Das DN: cn=Anita F Das, o, ou,
[email protected]. Anita F Das com, c=US Date: 2020.02.12 12:57:12 -08'00' Sulopenem IV; Sulopenem etzadroxil Iterum Therapeutics Statistical Analysis Plan: IT001-302 11 February 2020 TABLE OF CONTENTS TABLE OF CONTENTS...........................................................................................................