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Countries (USA, Canada) July 1988 Math 1989 Randomized, Double-Blind.

Double-Dummy, Placebo and Active Controlled 212 / 209/170 Alp XR, Alp IR, Placebo Sex: 38%, 42%, 45% female Age: 34,38,36 yr Race: 88%, 93%, 85% white Male and female 1 outpatients, between 16 phentermine quality viagra xanax and 65 years old, vrfth panic disorder with limited or exteroiva phobic avoidance Alp XR 1.0 mg tablets (65^17) Alp IR 1.0 mg tablets (24,021) Alp IR (XS mg tablets (23,649) Placebo tablets (24,028; 24,027; 21,472; 23,650) 1-10 mg/day or ptacebo po for6wk LV20G2/0002 9158-93-018 (27] 15 Centers 1i Country (USA) Junt 1990 October 1991 Randomized, Double-BUnd, Double-Dummy, Placebo Controlled 231/228/153 Alp XR 4 mg, Alp XR 6 mg. Placebo Sex: 52%, 56%, 48% female Age: 38 yr (afl grotpe) Race: 87%. 68% white Mate end female outpatients, between 18 and 65 years old, with panic dsorder atth agoraphobia Alp XR 0.5,1.0.2.0, or 3.0 mg tablets (35,674; 35,675,35,676; 35.677) Placebo (35,in tramadol hcl 678) 4 or 6 mg/day or placebo po forBwk M/2002/0003 9158-95-014(28] *15 Centers (Country (USA) May1990 (October 1901 Randomized, Double-BUnd, Double-Oummy, Placebo able phentermine viagra xanax Controlled 261/258/178 AlpXR 4 mg, AlpXR 6 mg.

68% white Male and female outpatients, between 18 and ' 65 years old, with panic deorder wtlh agoraphobia Alp XR (L5,1.0,2.0, or 3.0 mg tablets (35,674; 35.675,35,676; 35.677) Placebo (35.678) 4 or 6 mg/day or ptacebo po lor 6 wk M/2002/0032 O0096110 [29] AKhMutktlnna* &tn V 1 Center 1 Country (USA) 1994 1995 Randomized, Double-BUnd, Double-Oummy, Placebo Controlled 50/47/38* Alp XR, Placebo Sex: 42% female Age: NA Race: 90% white Male and female outpatients with panic dkorder vdth or without agoraphobia Alp XR 0.5 mg tablets (36,781) Placebo tablets (36,776) AlpXR up to 4 mg/day or placebo po for 8 wk - -- r --.. rivivuse, avaiiiiDte; po=arai; wK-weeks; yrsyears noted ar° °" 01 trealed ^ numb,rs o' randomteod, treated, and completed patients are taken born the study reports unless otherwise * The number completed Is bom the published literature (see Section 7.2). of Countries (Country) Start Date Complete Date Study Deslqn No. of Subjects/Patient* (Randomized / Treated / Completed) Sex Age Race Diagnosis ♦ Criteria for Inclusion (Population) Tested Agents (Acttva/Refersnce Therapy) Dosage Form / Lot No. Strength Route of Administration Treatment Regimen and Duration M/2002/0015 1340-96-001 [30] 22 Centers 0 Countries (Finland,. Italy,; Portugal, Russia, :>pain) Aprfl1993 January 1995 Randomized, Single (Evaluator)-Blind. Active Controlled 263/257/198 Alp XR, Clomipramine Sere 66X, 62% female Age: 35.34 yr Race: 78%. 80% white Male and female outpatients, between 18 and 65 years old, with panic disorder with or without agoraphobia Alp XR 0.5 or 1.0 mg tablets Clomipramine 10 or 25 mg encapsiiated tablets Packaging Lot Numbera/Country (91614, 91612,91608.91775. 91611, respectively) Alp able phentermine viagra xanax XR 2-6 mg/day or Clomipramine 50* 150 mo/day DO for 12 wk M/2000/0385 9159-91-007 [31] 1 Center 1 Country (USA) June 1969 April 1990 Randomized, able phentermine viagra xanax Dout"e-61ind. Double-Dummy, AcSve Controlled 22 / 20/16 Alp XR Alp IR Sex: 70% female Age: 41 yr Race: 95% hydrocodone v 3601 white Male and female outpatients, between 16 and 65 years otd, with panic disorder with or without agoraphobia Alp XR 1.0 or 2.0 mg tablets (35,675; 35.676) Alp IR 1.0 mg capsules (35.541) Alp XR or Alp IR 2 or 4 mg/day po for 2 wk (No discontinuation phase) M2002/0021 00027679[32] 1 Center 1 Country (USA) April 1993 December 1993 Open-Labei Switch Study 30 / 30 / 27 Sex: 70% female Age: 36 yr Race: NA Male and female outpatients, between 18 and 65 years old, with panic disorder with or without agoraphobia Alp XR tablets (26.689; 26,690) Alp |R tablets (26.667; 26,666) Alp IR 0.75-10 mg/day po for 3 wk followed by Alp XR 0.75-10 mo/day po for 8 wk Percentages are based on the number ol treated patients.

The numbers ot randomized, treated, and completed patients are taken from the stud/ reports unless otherwise noted. Table 4-3 4.4.2 Exposure - response relationships 4.4.2.1 How were the exposure-response relationships of efficacy and how to order oxycodone safety evaluated for XR or IR tablet, and was there a correlation? (Hossain's & Chou's review) Overall, alprazolam plasma concentration was not related to control of panic attacks after administering IR tablet.



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