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4/12/2022
Assess Bet Average ratng: 9,7/10 59 reviews
Secondary Outcome Measures : - Total symptom score (TSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]TSS is a combined score of TOSS and TNSS. TNSS and TOSS are scored as in part 1 each for a combined TSS of 0 (none) to 18 (severe)
- Total nasal symptom score (TNSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]Total nasal symptom score (TNSS) is from 0 to 12 and is based on assessment of 4 nasal symptoms graded on a Likert scale ranging from 0 (none) to 3 (severe) for congestion, itching, and rhinorrhea, and from 0 (none) to 3 (5 or more sneezes) for sneezing.
- Total ocular symptom score (TOSS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]Total ocular symptom score is 0 to 6 and is based on itching/redness/gritty feeling and tearing/watering; each of the 2 symptoms is graded 0 (absent), 1 (mild), 2 (moderate), and 3 (severe)
- Daily medication score (DMS), averaged over the duration of the birch pollen season, in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]The Daily Medication Score (DMS) is calculated by adding points for each pre-specified medication taken as follows: desloratadine 5 mg 6 points/dose; maximum daily score 6 points, olopatadine 1 mg/mL each drop 1.5 points/drop; maximum daily score 6 points, mometasone furoate 50 ug/dose 2.0 points/spray; maximum daily score 8 points). The scale is 0 (minimum) to 20 (maximum)
- Incidence of Treatment-Emergent Adverse Events (TEAEs) throughout the study [ Time Frame: Up to Day 127 ]
- Incidence of Serious TEAEs throughout the study [ Time Frame: Up to Day 127 ]
- Change from baseline to the end of study in birch SPT mean wheal diameter in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Baseline through Day 127 ]
- Percent change from baseline to the end of study in birch SPT mean wheal diameter in participants who receive a single dose of REGN5713-5714-5715 versus placebo [ Time Frame: Baseline through Day 127 ]
- Serum concentration of REGN5713 over the study duration [ Time Frame: Up to Day 127 ]
- Serum concentration of REGN5714 over the study duration [ Time Frame: Up to Day 127 ]
- Serum concentration of REGN5715 over the study duration [ Time Frame: Up to Day 127 ]
- Incidence of treatment emergent anti-drug antibodies to REGN5713 throughout the study [ Time Frame: Up to Day 127 ]
- Incidence of treatment emergent anti-drug antibodies to REGN5714 throughout the study [ Time Frame: Up to Day 127 ]
- Incidence of treatment emergent anti-drug antibodies to REGN5715 throughout the study [ Time Frame: Up to Day 127 ]
- Number of 'Well Days' [ Time Frame: Until the end of Birch Pollen Season, up to Week 16 ]'Well Days' are defined as days when rescue medication is not utilized and the Total symptom score (TSS) is ≤2/18
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Playing cards or dice for money, betting on sports games, playing slot machines, video poker or other video gambling, gambling on the internet, betting on horses or dogs, playing bingo or keno. During the past 12 months have you gambled 5 or more times? Yes No If yes continue to next 3 questions - Funded by DHMH/BHA. ASSESSMENT Purpose: To assess mobility Equipment: A stopwatch Directions: Patients wear their regular footwear and can use a walking aid, if needed. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor. 2 On the word “Go,” begin timing. 3 Stop timing after patient sits back down.