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Randomized (n= 88). Allocated to placebo and docetaxel (n= 45) ¨ Received allocated intervention (n= 44) ¨ Did not receive allocated intervention having failed exclusion criteria (n= 1). Allocated to aflibercept and docetaxel (n= 43) ¨ Received allocated intervention (n= 43)
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Randomized (n= 88) Allocated to placebo and docetaxel (n= 45) ¨Received allocated intervention (n= 44) ¨Did not receive allocated intervention having failed exclusion criteria (n= 1) Allocated to aflibercept and docetaxel (n= 43) ¨Received allocated intervention (n= 43) ¨Did not receive allocated intervention (give reasons) (n= 0) Allocation Lost to follow-up (n= 0) Discontinued intervention (n= 35) ¨Adverse event (n= 9) ¨Disease progression (n= 20) ¨Patient decision (n= 2) ¨Investigator decision (n= 3) ¨Withdrew consent (n= 1) • Lost to follow-up (n= 0) • Discontinued intervention (n= 38) • ¨Adverse event (n= 7) • ¨Disease progression (n= 21) • ¨Patient decision (n= 4) • ¨Investigator decision (n= 3) • ¨Withdrew consent (n= 2) • ¨ Other (n= 1) Follow-Up Analysed in Cycle 1 (n= 43)¨Excluded from analysis due to ECG data loss (n= 1) Analysed in Cycle 3 (n= 31) ¨Excluded from analysis having discontinued from study (n= 12) Analysed in Cycle 1 (n= 41)¨Excluded from analysis due to ECG data loss (n= 2) Analysed in Cycle 3 (n= 28) ¨Excluded from analysis having discontinued from study (n= 12) ¨Excluded from analysis due to ECG data loss (n= 1) Analysis Supplemental Figure 1