Re-ordering of secondary objectives and secondary efficacy endpoints. Clarification of safety secondary objective and endpoint to include the capture of subject Adverse Events as well as study wound (added) Adverse Events. Clarification of use of topical antimicrobial dressings and treatment and reformatting of pre-treatment bio-burden reduction components. Follow-up telephone contact time window changed. Addition of monthly follow-up phone contacts between Day 7 and Day 11 after each treatment. Added that in the event that a subject early terminates participation prior to Week 48, the subject or legal guardian/caregiver will be given the option to be contacted by the site through regular follow-up phone contacts post study termination. Addition of Study Completer Part A and Study Completer Part B definitions. Addition of pre-configured (on loan from Sponsor) digital image equipment. Clarification that ClinRO and CGIC are the same reported outcome (Clinician Global Impression of Change). The Intent-to-treat population and Per-protocol populations to include only subjects 3 years or older at the time of enrollment. The statistical considerations were updated for the clinical trial. Wound Care and Dressings: Addition that the lot number for each protocol specified wound care dressing dispensed will be captured on the applicable accountability log. Female Subjects: A definition of what constitutes a Female Of Child Bearing Potential (FOCP) has been added. Screening Period (Week -10): Only medications the subject is currently taking at the time of screening and information regarding exclusionary concomitant medications will be captured during the Screening Period. Subject Stopping Rules have been added. Planned Interim Analysis and Data Monitoring Committee: Steps for blinded sample size-re-estimation have been added.

Addition of procedure to report SAE information to Shire Medical Monitor in addition to Shire Pharmacovigilance and Risk Management (PVRM). Screening Period changed to begin at Week -6. Visit numbers altered to adjust to the screening period change beginning at Week -6. Screening visit window of ± 1 week added for Week -2. Clarification of the Central Reviewer role and the process to be followed between Week -6 and Week -2 for selection of wounds to receive bioburden pre-treatment reduction. Age of wound duration increased from 4 to 8 weeks. Wound selection criteria changed. Mepilex Lite foam dressing added to protocol specified dressings. Randomization of selected wound procedures (using an IWRS system) added regarding storage of randomization codes and breaking the study blind procedures. Wording was added to clarify that during the post treatment phone contacts, sites will also inquire about compliance with wound dressing change and bathing restrictions during the first 7-11 days post treatment. Inclusion criteria altered to allow the wound location to extend over the joint area if the joint area is immobilized or splinted. Addition of inclusion in another Shire Sponsored study pending Investigator assessment that participation does not interfere with any treatment aspect of the EB01-ABH001 study. Adverse and Serious Adverse Events Assessment: Wording was added for suspension of the application of ABH001 on an affected subject pending an immediate safety review by the Sponsor or designated service provider. Clarification for monthly follow-up phone contacts after early termination to occur according to weeks (4 weeks = 1 month).