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Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence\\*; progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).\n\n* Abstinence can be used as the sole method of contraception if it is in line with the participant's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS\u002FVisit 3 (i.e., pre-randomization for this study);\n2. Has, at the time of the base study EoS\u002FVisit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);\n3. Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S\u002FVisit 3, or of harm to others in the opinion of the investigator. 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It compares Elismetrep to a placebo.","completed","Long-Term Safety Study of Elismetrep for Migraine","This study is looking at the long-term safety of Elismetrep (K-304) for treating acute migraine attacks. You might be able to join if you have already completed a previous study of Elismetrep (Study K-304 P003) and met certain requirements in that study. Researchers want to see how many participants experience side effects (treatment-emergent adverse events or TEAEs), serious side effects (SAEs), or need to stop taking the study drug because of side effects. The study plans to enroll about 1000 people and is currently unclear about its recruitment status. You will receive either Elismetrep or a placebo (an inactive substance).","Participants will be followed through study completion, which is an average of 1 year.",100,"Not specified in the trial record.","Not stated in the trial record.",[30,38],"v2"]