AusPAR Attachment 2 Extract from the Clinical Evaluation ...
: This was reported for LCS12 (13.0%) and in LCS16 (20.9%). According to protocol, ovarian cysts were to be reported as AEs if they were abnormal nonfunctional cysts and/or had a diameter > 3 cm on ultrasound. Since the protocol required repeated vaginal ultrasound, incident ultrasound findings of cysts > 3cm were therefore documented as AEs. ................
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