Placebo treated women had a 1.9 incidence in cystic change over 3 years, whereas the FABLYN treated women had a 20.4 incidence.

The incidence of endometrial cystic change and endometrial thickness was analyzed in a subset of the study population (298 patients) with an annual transvaginal ultrasound (TVU) through 3 years.

These cystic findings contributed to an approximate 1.5 mm increase in mean endometrial thickness.

11 Lasofoxifene may be associated with benign endometrial effects endometrial cystic change viewed on ultrasound and histological benign cystic atrophy (a variant of atrophic endometrium), contributing to approximately 1.5 mm increase in mean endometrial thickness.

FABLYN increases risk of venous thromboembolism (VTE). The approaches recommended for mitigation of risk of venous thromboembolism based on the SmPC, including contraindication of FABLYN in patients with active or past history of VTE. FABLYN causes morphologic changes, particularly the cystic atrophy of endometrium.

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Periodic safety reports, follow up measures and specific obligations 2000 2002

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If within thirty days of the request for arbitration either Party has not designated an arbitrator, the other Party to the dispute may request the President of the International Court of Justice to appoint an arbitrator to the Party which has not designated an arbitrator.

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