Protocol

♦ What type of ethics review was done?

♦ How was the study managed - was there a steering group? Did it have independent members? (see Section 8.10).

♦ Was there an independent data monitoring and ethics committee? (see Section 8.10). Methods

♦ How were data collected and checked; was any source data verification carried out? Results

♦ Give the date of analysis/freezing of database for analysis.

♦ How many centres randomized patients?

♦ Quantify the maturity of time-to-event data by stating both the number of events and the minimum, maximum and median follow-up time in each group (see Section 9.3.4).

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