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An AE can therefore be any unfavorable and unintended including an abnormal laboratory findingsymptom, or disease new or exacerbated temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits i. The severity of AEs was assessed by the investigator as mild, moderate or severe.

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Baseline was Hext 0. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values. Mean change from Baseline in heart rate at Week 12 are presented.

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Mean change from Baseline in T4 and insulin at Week 12 are presented. Mean change from Baseline in fasting lipid profile at Week 12 are presented.

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In the event the TVUS hog not well visualized or there were abnormal findings at either visit, or the bi-layer thickness exceeded 5 millimeter at Week 12, a SIS was conducted to visualize the anterior and posterior walls. Mean change from Baseline and Week 12 in heart rate are presented.

These procedures were performed by an experienced physician. Each biopsy was obtained after the TVUS was performed.

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Proliferative endometrium also meant hyperplasia without atypia normal. All participants were required to return to clinic for Womeh Visit. Duration of spotting or bleeding is presented.

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The frequency was assessed using the question 1 as "Since you started the study medication, how has the of ht hot flashes including night sweats changed? Adjusted mean is presented as least square mean. Although hormone replacement therapy HRT is highly effective in reducing hot flashes, long-term HRT is associated with increased rates of breast cancer and heart disease. Safe, effective, and well-tolerated hot flash therapies are needed. The amino acids L-methionine and L-isoleucine have produced reductions in hot flash frequency.

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However, long-term L-methionine therapy may increase cardiovascular risks. This study will evaluate the short-term effects of L-isoleucine therapy. Data from this study will be used to conduct long-term studies in the future. Participants in this study will be randomly ased to receive one of two different L-isoleucine doses for 2 weeks. Clinic visits will be made at baseline, Week 1, and Week hog Participants will record the frequency and severity of their hot flashes in a diary.

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❶The pH indicator strip was inserted to the upper portion of the proximal one third of the vaginal vault, placed in contact with the lateral vaginal mucosal wall for approximately 1 minute, and evaluated according to the instructions text hot women in the package labeling. Change from Visit 2 to Visit 8 was calculated by subtracting Visit 2 values from Visit 8 values. Items 2- 4 ask for continuous response in hours.

Mean change from Baseline in T4 and insulin at Week 12 are presented. Lowest score 0 indicates best sleep quality and higher score indicates worst sleep quality.

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The last confirmed reading was recorded in the electronic case report form. Higher score indicates more severe fatigue.

Baseline was Week 0. Mean change from Baseline at Week 12 in estradiol are presented.

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Item 5 asks for response on rating scale related to WP ranging from 0:Menopausal symptoms had no effect on work to Couldn't work at all. Mean change from Baseline in fasting lipid profile at Week 12 are presented.

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