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Treatments consisted of a single intra-articular injection of 50 mg of Synacid. Table 6 Force Plate Clinical Efficacy Study: Distribution of Joints Treated Joint Left Right Total Carpus 5 9 14 Front Fetlock 7 3 10 TOTAL 12 12 24 Force plate measurements were repeated when the joint was desensitized. payday loans Table 9 Force Plate Clinical Efficacy Study: Mean FPU of Control Horses * each value is the mean FPU of 4 readings. Anes = intra-articular anesthetic No untoward effects of Synacid injection occurred in any of the horses.

Only horses which fit these requirements were admitted into the study. The key follow-up visits with respect to drug efficacy were at 7 and 14 days.

A repeat treatment at the one week visit was optional depending on response. Table 11B lists the demographic and medical history variables of the horses. Table 11A Positive Controlled Clinical Field Trial: Disposition of Cases Table 12 Positive Controlled Clinical Field Trial: Analysis of Lameness Grade TJ-CJ = Treated joint circumference minus contralateral joint circumference. Table 14 Positive Controlled Clinical Field Trial: Joint Heat and Effusion

Synovial Fluid viscosity did not increase following treatment with either drug. Table 15 summarizes the data on synovial fluid protein and viscosity.

In the 'good' category there were 10 Synacid and 12 control drug horses. These effects can be anticipated following any intra-articular procedure. Dr. A. Kent Allen Equine Medical Services Box 749 Gilbert, Arizona 85234 Dr. Richard A. Frank Windview Acres R.D. 1 Stillwater, New York 12170 Dr. H. Valdez Equine Sports Surgery Centre King Street Uxbridge, Mass. Dr. Daniel Marks Delaware Equine Centre R.D. 2 Cochranville, Pa. 19330

Dr. Gary Norwood Back-Stretch Surgery and Medicine Inc. 539 Bonnabel Blvd. Dr. R.J. Shive Penn Hills Equine Hospital R.R. 4 Shubenacadie, Nova Scotia

Series B data was collected weekly for 6 consecutive weeks post-treatment. Total improvement was taken as the sum of 'good' and 'fair' responses. Table 16 Corroborative Field Study: Table of Means of Response Parameters The final performance evaluation was comparable in carpal and fetlock joints. Data on quantitative parameters was analyzed using an analysis of variance. No clinically or statistically significant changes occurred in body weight. Statistically significant changes were found in the means of body temperature. Most of the values for blood parameters were within the normal equine range. Treatments did not result in any adverse local reactions or signs of toxicity. These changes are ascribed to the cumulative trauma of frequent arthrocentesis.

No adverse reactions and no signs of systemic or local toxicity occurred. These observations were repeated one week following the final injection. Horses in the highest dose group (group 3) were euthanized at the end o!

The one exception was not a large change and was not abnormally elevated. Synovial fluid was withdrawn weekly from treated and control carpal joints.

These changes are attributed to physical trauma due to injection procedures. Upon receipt of the completed FFDM package, FDA will review the documentation. Back to Full Field Digital Mammography (FFDM) Certification Extension Program Unapplied or unidentified checks must be reconciled within 30 business days. The financial management system will be down during the year end close period. If no check is received within a business day, no bank deposit is required. 5. Document History -- SMG 2310.11, Receiving and Depositing Checks

Retavase® (Centocor, Inc.)     Acute myocardial infarction Proposed Regulatory Research Project for the FDA Commissioner's Fellow: [http://pacer.cade.uscourts.gov/docs/common/opinions/200401/03-5020a.pdf -

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