Table 1 Trial phases and time frame for receipt of study documentation

Screening data

Mailed to CTEU within 17 days of randomisation

In-hospital data

Mailed to CTEU within 17 days of the surgery

6 week follow-up

Mailed to CTEU within 17 days of follow up visit

Annual follow-ups

Mailed to CTEU within 17 days of follow up visit

Edit queries

Faxed to CTEU within 3 weeks of receipt

Adverse event form

Faxed to CTEU within 72 hours of knowledge of the event