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Accrual

and analysis details

672 patients randomized

between December 2014 and August 2016

Data cut-off date:

August 20, 2017 (318 events)

Median time from randomization to data cut-off date:

19.2 months

+ Tamoxifen

n=90

+ NSAI

n=248

Full analysis

set

Safety set

+ Tamoxifen

n=87

+ NSAI

n=247

Ribociclib

Placebo

Received treatment

n=335

Received treatment

n=337