Click below to download study documents

Study Report

Study Report (Jan 2015)

Investigator List

Investigator List (Final Feb 2017)

Study Protocols

Study Protocol in English (version 1.0)

Study Protocol in German (version 1.0)

Study Protocol in Portuguese (version 1.0)

Study Protocol for India (version 1.0)

Statistical Analysis Plan (version 1.0)

CRF and Slides

Final Case Record Form (version 2.3)

ISOS Slide Set

Online Database User Guide

Definitions and FAQs

Guidance on definitions and grading for complications (version 1.1)

Current version of the FAQs

Current version of the UK FAQs

SOP for reopening sites for data correction

Trial registration information

UK Ethics Approval Letter

ICRCTN registration (number: ISRCTN51817007)

UK CRN Portfolio ID : 15731

Consent

Patient Information Sheet (version 1.1)

Consent form (version 1.1) - only required in certain countries.

Last updated: 18th May, 2021