ANONYMOUS: "A Long-term Extension Study of TAK-385 in the Treatment of Endometriosis - ClinicalTrials.gov", 8 May 2014 (2014-05-08), XP055460104, Retrieved from the Internet <URL:https://www.clinicaltrials.gov/ct2/show/NCT01452685?term=TAK-385&draw=3&rank=12> [retrieved on 20180316] (B1)

ANONYMOUS: "Efficacy and Safety of TAK-385 in the Treatment of Endometriosis - ClinicalTrials.gov", 25 February 2014 (2014-02-25), XP055460103, Retrieved from the Internet <URL:https://www.clinicaltrials.gov/ct2/show/NCT01458301?term=TAK-385&draw=2&rank=11> [retrieved on 20180316] (B1)

ANONYMOUS: "Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids - Full Text View - ClinicalTrials.gov", 21 January 2013 (2013-01-21), XP055460100, Retrieved from the Internet <URL:https://www.clinicaltrials.gov/ct2/show/NCT01452659?term=TAK-385&rank=9> [retrieved on 20180316] (B1)

ANONYMOUS: "NCT02655224 on 2016_09_29: ClinicalTrials.gov Archive", 29 September 2016 (2016-09-29), XP055460097, Retrieved from the Internet <URL:https://clinicaltrials.gov/archive/NCT02655224/2016_09_29> [retrieved on 20180316] (B1)

ANONYMOUS: "NCT02655237 on 2016_09_14: ClinicalTrials.gov Archive", 14 September 2016 (2016-09-14), XP055460098, Retrieved from the Internet <URL:https://clinicaltrials.gov/archive/NCT02655237/2016_09_14> [retrieved on 20180316] (B1)

WO-A1-2014/143669 (B1)

DATABASE MEDLINE [online] US NATIONAL LIBRARY OF MEDICINE (NLM), BETHESDA, MD, US; January 1998 (1998-01-01), HORNSTEIN M D ET AL: "Leuprolide acetate depot and hormonal add-back in endometriosis: a 12-month study. Lupron Add-Back Study Group.", XP002779261, Database accession no. NLM9464714 (B1)

KAZUHIRO MIWA ET AL: "Discovery of 1-{4-[1-(2,6-Difluorobenzyl)-5-[(dimethylamino)methyl]-3-(6-methoxypyridazin-3-yl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3- d ]pyrimidin-6-yl]phenyl}-3-methoxyurea (TAK-385) as a Potent, Orally Active, Non-Peptide Antagonist of the Human Gonadotropin-Releasing Hormone Receptor", JOURNAL OF MEDICINAL CHEMISTRY, vol. 54, no. 14, 28 July 2011 (2011-07-28), pages 4998 - 5012, XP055012890, ISSN: 0022-2623, DOI: 10.1021/jm200216q (B1)

M/S. REPORTSTACK: "Endometriosis - Opportunity Analysis and Forecasts to 2017", 4 February 2014 (2014-02-04), XP055460148, Retrieved from the Internet <URL:https://www.prnewswire.com/news-releases/endometriosis---opportunity-analysis-and-forecasts-to-2017-243490131.html> [retrieved on 20180316] (B1)

NAKATA DAISUKE ET AL: "Suppression of the hypothalamic-pituitary-gonadal axis by TAK-385 (relugolix), a novel, investigational, orally active, small molecule gonadotropin-releasing hormone (GnRH) antagonist: Studies in human GnRH receptor knock", EUROPEAN JOURNAL OF PHARMACOLOGY, vol. 723, 11 December 2013 (2013-12-11), pages 167 - 174, XP028607987, ISSN: 0014-2999, DOI: 10.1016/J.EJPHAR.2013.12.001 (B1)

OBSTETRICS AND GYNECOLOGY JAN 1998, vol. 91, no. 1, January 1998 (1998-01-01), pages 16 - 24, ISSN: 0029-7844 (B1)

ANONYMOUS: "Roivant Sciences and Takeda Launch Myovant Sciences to Develop Innovative Therapeutics for Women's Health and Prostate Cancer", 6 June 2016 (2016-06-06), XP055459497, Retrieved from the Internet <URL:http://investors.myovant.com/tools/viewpdf.aspx?page={7F19DBB5-53F9-43CE-8BF9-CCE79BD044BD}> [retrieved on 20180314] (B1)