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Primary endpoint: PFS (investigator-assessed)

CI, confidence interval; NR, not reached.

Goserelin included in all combinations.

Probability of PFS (%)

Time (months)

No. at risk

Ribociclib + tamoxifen/NSAI

335 301 284 264 245 235 219 178 136 90 54 40

20

3

1

0

Placebo + tamoxifen/NSAI

337 273 248 230 207 183 165 124 94 62 31 24

13

3

1

0

PFS (investigator

assessment)

Ribociclib + tamoxifen/NSAI n=335 Placebo + tamoxifen/NSAI

n=337

Number of events, n (%)

131 (39.1)

187 (55.5)

Median PFS, months

(95% CI)

23.8

(19.2–NR)

13.0

(11.0–16.4)

Hazard ratio (95% CI)

0.553 (0.441–0.694)

One-sided p value

0.0000000983

10

8

6

4

2

0

100

80

60

40

20

0

30

28

26

24

22

20

18

16

14

12

10

30

50

70

90