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Note: For a description of references and other information, refer to the explanation of Committee tables and the accompanying notes at the end of this table. Footnotes: * Partially confirmed by bank information sources 10-14 ; * Fully confirmed by bank information sources 10-14 ; 1. Side agreement with Government of Iraq. 2. Ministry correspondence documents. 3. Company correspondence documents. 4. Other documents. 5. Ministry financial data. 6. Projected ASSF levied based on Government of Iraq policy documents. 7. Projected ASSF paid based on Government of Iraq policy documents. Represents contracts where inland transportation fee was required but no specific information was available 8. Projected Inland Transportation fees based on Government of Iraq policy documents. 9. Amount based on information provided by company and ministry documents. 10. Housing Bank for Trade and Finance Jordan ; , Central Bank of Iraq accounts Jan. 1, 2001 to Dec. 31, 2003 ; . 11. Jordan National Bank Jordan ; , Alia Company for Transport and General Trade accounts Mar. 1, 2000 to Dec. 31, 2003 ; . 12. Al-Rafidain Bank Jordan ; , Central Bank of Iraq accounts Jan. 1, 2000 to May 15, 2003 ; . 13. Fransabank SAL Lebanon ; , Central Bank of Iraq accounts Nov. 12, 2002 to Dec. 19, 2002 ; . 14. Jordan National Bank Jordan ; , Arrow Trans Shipping Company accounts May 1, 2001 to Dec. 31, 2001 ; . Page 287 of 381, for example, bactroban herpes.
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Of area 3a neighboring the representational zone of digit 5 in area 3b. In monkey OM 2149, all comparisons of single RF sizes recorded within area 1 in the IPSI PRE C 21.63 11.59 mm2 ; n 7 ; , IPSI POST X 24.90 27.07 mm2 ; n 18 ; , and 2 CONTRA POST C 29.08 14.13 mm ; n 34 ; maps showed no statistically significant differences [F 2, 57 ; 0.61; P 0.55]. Interestingly, comparisons of the three maps in terms of neural response sensitivity revealed that weak, clear, and strong responses were found in equal proportions in area 1 on the IPSI POST X side, whereas weak responses 71% ; predominated over clear 14.5% ; and strong 14.5% ; responses in the IPSI PRE C map and clear 53% ; or weak 38% ; responses were mainly encountered in the CONTRA POST C hemisphere. As indicated in Table 2, differences between the three populations of RFs were all statistically significant. About 67% of the strong or clear responses were observed for RFs located on either digit 2, 3, or 4 on the IPSI PRE C side, whereas a smaller proportion 50% ; of strong or clear responses was found for RFs located on the homologous digits of the hand representation derived in the CONTRA POST C hemisphere. As far as area 3a was concerned, single RFs recorded on the IC side were found for 46% 13 28 ; of the cortical sites, with a mean RF surface of 10.81 6.37 mm2 . These RFs were mainly located on the tip of digits 24. Clear responses 77% ; prevailed over weak ones 23% ; . Multiple RFs, all located on the fingertips, were observed for 54% 15 28 ; of electrode penetrations. On the average, these multiple RFs exhibited 2.3 0.6 subfields. Subfields were mainly located on digits 3 40% ; and 4 37% ; , and most subfields associated with the same recording site were located either on digits 3 and 4 59% ; or on digits 24 20% ; , which were the finger segments most frequently stimulated on the pelletretrieval task during the postoperative period. The subfields generally were restricted to small skin surfaces, as indicated by their mean sizes 11.35 3.41 mm2 ; . Clear responses were most common 45% strong 26% ; and weak 28% ; responses were less frequent. As a general rule, responses to cutaneous stimulation were of similar sensitivity for the subfields recorded at a given recording site. In some instances, however, a best response could be defined for a particular subfield. Overall, the occurrence of best responses was similar for subfields on digits 24. Mixed cutaneous and high-threshold receptor inputs were encountered at 37% of the recording sites, particularly for about half of the sites with weak responses. In OM-2147, no recording was done in area 1 before the lesion. Cross-hemispheric comparisons of the RF characteristics in this area were made at the chronic stage of the lesion. The great majority of sampled cortical sites displayed single RFs, both in the IPSI POST X 20 22; 91% ; and CONTRA POST C hemispheres 16 17; 94% ; . However, RFs were smaller on the average on the side of the lesion 32.56 20.67 mm2 vs. 51.64 33.71 mm2 ; t-test: P 0.04 ; . The majority of the RFs 85% ; were located on digits 2 and 3, i.e., on the fingers preferentially used for pellet retrieval. Responses were generally strong 55% ; or clear 40% ; , but all strong responses were found for RFs located on digit 2 64% ; or digit 3 36% ; . No data on response sensitivity were available for the intact hemisphere, for example, bactroban topical ointment.
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Clinical Studies The efficacy and safety of OXYTROL were evaluated in patients with urge urinary incontinence in two Phase 3 controlled studies and one open-label extension. Study 1 was a Phase 3, placebo controlled study, comparing the safety and efficacy of OXYTROL at dose levels of 1.3, 2.6, and 3.9 mg day to placebo in 520 patients. Open-label treatment was available for patients completing the study. Study 2 was a Phase 3 study, comparing the safety and efficacy of OXYTROL 3.9 mg day versus active and placebo controls in 361 patients. Study 1 was a randomized, double-blind, placebo-controlled, parallel group study of three dose levels of OXYTROL conducted in 520 patients. The 12-week double-blind treatment included OXYTROL doses of 1.3, 2.6, and 3.9 mg day with matching placebo. An open-label, dose titration treatment extension allowed continued treatment for up to an additional 40 weeks for patients completing the double-blind period. The majority of patients were Caucasian 91% ; and female 92% ; with a mean age of 61 years range, 20 to 88 years ; . Entry criteria required that patients have urge or mixed incontinence with a predominance of urge ; , urge incontinence episodes of 10 per week, and 8 micturitions per day. The patient's medical history and a urinary diary during the treatment-free baseline period confirmed the diagnosis of urge incontinence. Approximately 80% of patients had no prior pharmacological treatment for incontinence. Reductions in weekly incontinence episodes, urinary frequency, and urinary void volume between placebo and active treatment groups are summarized in Table 2. Table 2: Mean and median change from baseline to end of treatment Week 12 or last observation carried forward ; in incontinence episodes, urinary frequency, and urinary void volume in patients treated with OXYTROL 3.9 mg day or placebo for 12 weeks Study 1 ; . Parameter Mean SD ; Weekly Incontinence Episodes Baseline Reduction p value vs. placebo Daily Urinary Frequency Baseline Reduction p value vs. placebo Urinary Void Volume mL ; Baseline Increase p value vs. placebo 37.7 24.0 ; 19.2 21.4 ; -- 12.3 3.5 ; 1.6 3.0 ; -- 175.9 69.5 ; 10.5 56.9 ; -- 166.5 5.5 11 Placebo N 127 ; Median OXYTROL 3.9 mg day N 120 ; Mean Median SD ; 34.3 18.2 ; 21.0 17.1 ; 0.0265 * 11.8 3.1 ; 2.2 2.5 ; 0.0313 * 171.6 65.1 ; 31.6 65.6 ; 0.0009 * 168 26 11!
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AIDS-Related Kaposi's Sarcoma In patients with AIDSRelated Kaposi's Sarcoma, some type of adverse reaction occurred in 100% of the 74 patients treated with 30 million IU m2 three times a week and in 97% of the 29 patients treated with 35 million IU per day. Of these adverse reactions, those classified as severe World Health Organization grade 3 or 4 ; were reported in 27% to 55% of patients. Severe adverse reactions in the 30 million IU m2 TIW study included: fatigue 20% ; , influenza-like symptoms 15% ; , anorexia 12% ; , dry mouth 4% ; , headache 4% ; , confusion 3% ; , fever 3% ; , myalgia 3% ; , and nausea and vomiting 1% each ; . Severe adverse reactions for patients who received the 35 million IU QD included: fever 24% ; , fatigue 17% ; , influenza-like symptoms 14% ; , dyspnea 14% ; , headache 10% ; , pharyngitis 7% ; , and ataxia, confusion, dysphagia, GI hemorrhage, abnormal hepatic function, increased SGOT, myalgia, cardiomyopathy, face edema, depression, emotional lability, suicide attempt, chest pain, and coughing 1 patient each ; . Overall, the incidence of severe toxicity was higher among patients who received the 35 million IU per day dose.
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At RR 600 msec heart rate 100 beats per min ; QT-interval prolongation was significant 6 and 8 hours post-drug administration when the combination was compared with placebo and terfenadine respectively p 0.05 ; . At RR 700 msec heart rate 85 beats per min ; sparfloxacin alone and in combination with terfenadine prolonged the QT-intervals which was significant when compared with placebo or terfenadine, 6 and 8 hours post-drug. At RR 800 msec heart rate 75 beats per min ; sparfloxacin and terfenadine combination prolonged the QT-interval 2, 4, 6 and 8 hours after administration of the study drugs. Sparfloxacin alone produced significant prolongation at 6 and 8 hours after drug administration. At RR 900 msec heart rate 66 beats per min ; QT-interval was significantly prolonged by the combination of sparfloxacin and terfenadine at 2, 4, 6 and 8 hours after drug administration, while sparfloxacin mediated prolongation was observed at 6 and 8 hours post-dose. At RR 1000 msec heart rate 60 beats per min ; findings similar to that of RR 900 msec were observed with sparfloxacin alone and in combination with terfenadine when compared with placebo. DISCUSSION The results of the study showed that sparfloxacin alone and in combination with terfenadine increased the QT-interval. There was no significant increase in the QT-interval duration induced by terfenadine the difference in mean QT interval was 7.5 + 0.6 msec and % change as compared to placebo was 2.3 + 0.04 % ; . The QT-interval duration induced by sparfloxacin alone was significant p 0.05 ; , the difference in mean QT-interval and % change as compared to placebo were 14 .1 + 0.8 msec and 4.3 + 0.18 % respectively. The difference in mean QT-interval and % change as compared to placebo were 24.7 + 4.5 msec and 7.3 + 0.71 % respectively after administration of the combination of sparfloxacin and terfenadine. There was no significant sparfloxacin-terfenadine interaction, changes in QT-interval produced by the combination were only additive. Sparfloxacin produces a dose dependent increase in the QT-interval with significant prolongation ap!
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From the 2nd Department of Internal Medicine and the Department of Pathology and Surgical Pathology, University of Occupational and Environmental Health Japan, School of Medicine, 1-1, Iseigaoka, Yahatanishiku, Kitakyushu, Japan. Address for reprints: Dr. Yasuhide Nakashima, The 2nd Department of Internal Medicine, University of Occupational and Environmental Health Japan, 1-1, Iseigaoka, Yahatanishiku, Kitakyushu, 807, Japan. Received May 22, 1985; revision accepted November 25, 1985.
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