Presence of active healing fracture at screening.
History and/or presence of 1 severe or >2 moderate vertebral fractures or hip fracture confirmed by x-ray.Written informed consent including accepting a separate Information Sheet containing important information about COVID-19 and its general risks for participants participating in the clinical trial.Clinically acceptable physical examinations and laboratory tests and no history or evidence of any clinically significant concomitant medical disorder that, in the opinion of the Investigator, would pose a risk to participant safety or interfere with study evaluations or procedures.At least 2 vertebrae in the lumbar vertebrae 1 to lumbar vertebrae 4 (L1-L4) region and at least 1 hip joint are evaluable by DXA.Absolute bone mineral density (BMD) consistent with T-score ≤-2.5 and ≥-4.0 at the lumbar spine as measured by dual energy x-ray absorptiometry (DXA) as per central assessment.Participant should have confirmed postmenopausal status, defined as age-related or early/premature amenorrhea ≥12 consecutive months and increased follicle-stimulating hormone (FSH) >40 mIU/mL at screening or surgical menopause (bilateral oophorectomy with or without hysterectomy) ≥12 months prior to screening.Have a body mass index (BMI) ≥18 to ≤32 kg/m^2.Female ≥55 to ≤85 years of age, inclusive, at screening.Participants who were randomized to receive FKS518 at the beginning of the Double-blind Core Treatment Period will continue to receive this treatment during the Double-blind Transition Period.įor Marketing Authorization Application (MAA) in the EU and European Economic Area (EEA) only: The primary objective is to demonstrate equivalent efficacy and pharmacodynamics of the proposed biosimilar denosumab FKS518 to US-Prolia in women with PMO. Participants will be randomized at the beginning of the Double-blind Core Treatment Period (Baseline to Week 52) to receive either FKS518 or US-licensed Prolia on Day 1, and then every 26 weeks for up to 52 weeks.Īt the beginning of the Double-blind Transition Period (Week 52 to Week 78), participants who received US-licensed Prolia will be re-randomized to either continue receiving US-licensed Prolia every 26 weeks for up to 78 weeks, or switch to receive FKS518 every 26 weeks for up to 78 weeks. The primary objective of this study is to demonstrate equivalent efficacy of FKS518 to US-licensed Prolia in women with postmenopausal osteoporosis (PMO). Why Should I Register and Submit Results?.We have also created a cool little tool that will calculate the total Number of Games in a Tournament. Whoever wins that game would then be the champions. If the team from the Loser's Bracket wins, then game 15(dotted lines) in the above illustration would be played.
If the team from the Winner's Bracket wins then they are the champions. Game 14 in the above illustration is the Championship between the Winner of the Winner's Bracket(Zero Losses) and the Winner of the Loser's bracket(1 Loss). All you have to do is look at the Winner's Bracket to see what game number was played, and the loser of that game would drop down to the corresponding location in the losers bracket.ĭ: The letter "D" represents the Championship game. Simply start by playing the game labeled (1) and continue until all games are completed.Ĭ: The letter "C" points to the position where the loser of each game would move to. If you are printing a blind draw bracket these numbers will not appear on the bracket, but the rest of the bracket will be exactly the same.ī: The letter "B" points to the order in which the games are to be played. The same idea is used for all brackets, not matter what the number of participants are.Ī: The letter "A" points to the "Seeds" of the tournament, if you have pre-ranked your participants based on strength or a season record you would put each team's name on the corresponding line. The bracket above is a 16 Team "Seeded" double elimination bracket. If you are not familiar with running double elimination tournaments, the above illustration and the comments below should help guide you through setting up and running your tournament. We also have printable Single Elimination Brackets and Triple Elimination Brackets available. The two sections above are broken up between "Blind Draw" and "Seeded".
LATEX BRACKETS TABLE FREE
The Double Elimination brackets above are free to print.
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