Clinical Trial Log (daily diary) - EBY'S^TM CONCENTRATED Gallium Nitrate Mineral Water
for Experimental Treatment of Navicular Disease in Horses

Eby's^TM Gallium Nitrate Mineral Water (14.0% Gallium nitrate - CONCENTRATE) is suitable only for dilution to 1.0% daily doses prepared in fourteen 500mL (1 pint) bottles of water. This 14% concentrate will cause human and animal eye, mouth and skin injury. You must dilute it as directed on the label.

The 1.0% diluted doses are used in the experimental treatment of navicular disease in horses following strict instructions on bottle.

As part of a clinical trial, you will be expected to keep and return this daily diary to Eby Pharma, LLC to be eligible for $40 refund. In this first-of-its-kind clinical trial for navicular disease, there are no placebos. All horses receive active ingredient.

Please keep accurate records, because the results of this clinical trial will be used to prepare an original scientific article suitable for publication in a medical/veterinary/science journal. No data submitted for publication will contain personally identifiable information. All data will be confidential. Be aware that soundness may occur only after treatment for several months, and may require continued treatment to maintain soundness.

Please fill out this form. Return entire form to: Eby Pharma LLC, P. O. Box 1142, Dripping Springs, TX 78620.

Your name: _____________________ Mailing address ______________________ City __________________

State _____ Zip Code ___________ Email Address ______________________________________________

Horse’s name: _________________ Sex ______ Horse’s age at diagnosis: ____________

How many months has your horse been previously treated with gallium nitrate? ___________

Your horse’s age at start of clinical trial: _______ Your horse’s breed: _______________

Your horse’s clinical (veterinarian) diagnosis: ____________________________________________

Your veterinarian’s related current treatment for your horse:________________________

Your farrier’s related current treatment for your horse: _____________________________

Is this horse using aluminum shoes? _________ If yes, they must be removed for this product to work.

DAILY DATA COLLECTION RATING SYSTEM: Daily scores range in severity 0 through 4.

• Rating scale “0” means that the horse stands, walks, trots, canters, gallops and runs with no visible evidence of lameness on this day.

• Rating scale “1” means that the horse is slightly lame in at least one gait on this day.
• Rating scale “2” means that the horse is too lame to move comfortably, but uses all four feet with difficulty on this day.
• Rating scale “3” means that the horse is severely lame, is in pain and moves with difficulty by withholding most weight from the navicular foot on this day.
• Rating scale “4” means that the horse is extremely lame, and is in obvious extreme pain (holds foot off ground) at nearly all time on this day. Candidate for euthanasia on this day.

NOTE: If a day(s) of treatment in the first 14 days is missed, indicate “no” for that specific day, and use that dose for day 15 (and later days).

Fill out the following record for each day of the month. Every day of the third column must be completed to receive refund. If you miss a daily observation for the third column (How lame is your horse today?), guess! But fill in that column for each and every day! Your guess will be better than ours. We cannot use incomplete data.

Your horse’s Name? Day 1 date?	Did you give gallium nitrate today?	How lame is your horse today? (Use rating scale shown above) (OK to use decimal fractions)	What gait(s) does lameness appears)	Side Effects observed?	Comments: NOTE: THIS PRODUCT WILL NOT WORK IF ALUMINUM SHOES ARE USED
Example Day x	Yes (fill out for each of 28 days)	3 MANDATORY Fill in all 28 days, not just the first 14 days VERY, VERY VERY IMPORTANT	Trot (fill out for each day lameness seen)	He hick-ups. (fill out for each day where side effects are noticed)	I really hope this works. He is so lame. I am worried.
Day 1		fill in all 28 days
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Day 8
Day 9
Day 10
Day 11
Day 12
Day 13
Day 14
Day 15		fill in all 28 days
Day 16
Day 17
Day 18
Day 19
Day 20
Day 21
Day 22
Day 23
Day 24
Day 25
Day 26
Day 27
Day 28		fill in all 28 days

ADDITIONAL INSTRUCTIONS: Be consistent! Treat in morning feeding if possible. If a morning dose is missed, then give it in evening feed. Give dose only once a day. Please make daily observations (particular “How lame is your horse today?”) to be eligible for $40 refund. Again, be consistent!

CONSENT: I give my consent to experimental gallium nitrate treatment: I enter my horse (name above) in this clinical trial solely to collect data concerning the effectiveness of gallium nitrate in the treatment of navicular disease in my horse. George Eby and Eby Pharma, LLC have not made representations concerning safety or efficacy of gallium nitrate in treatment of my horse. George Eby and Eby Pharma, LLC are not responsible for any injury that I, anyone under my control, or my horse may endure. I am informed that gallium nitrate is used in humans as a medicine for treatment of bone disorders. I have read warnings and precautions and agree to abide by safety recommendations.

Signed: ___________________________________

Dated: ________________________________________

Your additional comments and observations of effect of treatment at end of 14 days treatment (use reverse side if necessary)?

If your horse was shod with aluminum shoes, did removal of them help? _____________

Your veterinarian’s comments and observations (if any) of effect of treatment at end of 14 day treatment (use reverse side if necessary)?

---

Please return this completed form to:

Eby Pharma, LLC,

P. O. Box 1142

Dripping Springs, Texas, 78620 USA

Questions? Telephone and fax number 1-512-263-0805

Fee paid?: _____________ Refund Eligible?: Yes ______ No _______

Refund paid with check number: ________________