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Dear Colleague, wanted to share some information about The CONSORTIUM clinical study, sponsored by Vedanta Biosciences, as it may be of interest to you and to some of your patients.

This study is testing the safety and effectiveness of an experimental drug called VE303 compared to a placebo (a capsule containing no VE303), for the prevention of recurrent C. difficile infections. VE303 is a preparation of eight different types of bacteria that are grown in clean conditions, dried, powdered and put into capsules. The bacteria are activated once they reach the intestines. VE303 is manufactured from clonal cell banks of pure, uniform compositions, bypassing the need to rely on fecal transplants direct sourcing of fecal donor material of inconsistent composition, and in some cases unknown safety. The study drug is administered orally for 14 days. VE303 is being studied to see if it can help get patients’ intestinal bacteria back to a healthy state after an episode of CDI, and potentially reduce the chance of CDI from returning.

Thank you for participating in the CONSORTIUM study for rCDI. This brochure should help you understand your participation requirements for the clinical trial.

Preclinical data and a previous study in healthy volunteers suggest that VE303 may help reestablish resistance against C. diff by accelerating restoration of the gut microbiota from damage caused by antibiotics. The safety study of VE303, showed that the doses used in that study were safe and well tolerated in healthy volunteers.

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duration of this study is approximately 7 months. You come for 7 scheduled visits at the clinic, and contacted by phone (during the 14-day dosing (except for visit days) and at Week 12, Week 16 and

When you are in a medical research study, you are expected to come to all your study visits and to follow the instructions given to you by your study doctor and study research team.

• You must let your study doctor know of any changes in your health while you are in this study.

Have an active episode of CDI, have not been on antibiotic treatment for more than 72 hours and fall into 1 of these 3 categories: o At least 18 years of age and have experienced a prior episode of CDI within the last 6 months o Between the ages of 65 and 74 (inclusive) with or without prior episodes of CDI who exhibit one or more of the following risk factors for recurrence: o Have kidney dysfunction, defined as creatinine clearance of <60mL/min/1.73m2 at the time of the current CDI episode; is testing the safety and effectiveness of an experimental drug, known as VE303, and its ability to from returning. VE303 is a preparation of different bacteria which were selected for their ability to prevent the regrowth of C. Difficile. selected bacteria are grown in clean controlled dried, powdered and put into capsules for oral administration where the bacteria become reactivated reach the intestines. VE303 is manufactured cell banks that yield a product of uniform composition, free of viruses and uncharacterized bacteria contrast with fecal transplants, which rely on sourcing of fecal donor material of inconsistent composition. experimental drug is a drug that has been approved and Drug Administration (FDA) to be tested population of volunteers. Preclinical data previous study in healthy volunteers suggest that help reestablish resistance against C. diff accelerating restoration of the gut microbiota from caused by antibiotics. The safety study of VE303, that the doses we are using in this study were well tolerated in healthy volunteers.

Please refer to your study dosing diary and instructions throughout this clinical trial.

• You should check with the study doctor before starting to take any new medications or remedies.

• If you or your partner becomes pregnant, you must notify your study doctor immediately.

• If you choose to stop your participation in the study for any reason, you must notify your study doctor imme diately so that a plan can be made for your continued medical care.

• You will be expected to return to the clinic for your final study visit.

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• Please do not give blood for non-study purposes, unless medically required, while you are taking part in this study. STUDY

Welcome o Have a history of regular use of proton pump inhibitors (PPI) such as omeprazole, pantoprazole, etc. within the past 2 months and will be continuing use of PPIs throughout the study; o Have a history of CDI at any time; o At least 75 years of age and are experiencing an active episode of CDI

All study-related visits, tests, and study medications will be provided to participants at no cost.

Please know that I will only see your patients within the context of this study. For any medical concerns outside this study, your patients will be directed back to you. If you are interested in learning more about this study, or would like to refer a patient, please contact at _

Thank you for your time and appreciate any consideration and support you might provide for this important research.

Sincerely,

*Additional study requirements apply.

RECURRING CLOSTRIDIUM DIFFICILE INFECTION

The CONSORTIUM clinical study included recruitment and retention materials to help patients and physicians navigate through the study. Materials included: recruitment flyers and brochures, welcome brochure, visit calendar, appointment cards, collection instructions, and physician letters. Recruitment packets and additional supplies were fulfilled and shipped to sites upon activation and on an as-needed basis.

The Reflect Study was a full brand development project that included naming, logo design, website and collateral pieces. The name “reflect” was inspired by the reflective nature of water, as many patients with this skin condition use water to sooth their symptoms. The imagery chosen for the brand included watercolor marks and photography of lakes, with abstracted portraits and reflections.

Testing the safety and effectiveness of a topical cream for adults and adolescents living with Ichthyosis.

The Reflect Study is testing the safety and effectiveness of a topical cream for adults and adolescents living with Lamellar Ichthyosis (LI). This investigational cream is applied to the surface of the skin in an effort to reduce LI symptoms such as dry and cracked skin. The Reflect Study aims to help improve symptoms of LI for current and future generations.

THOSE WHO QUALIFY FOR STUDY PARTICIPATION CAN EXPECT THE FOLLOWING:

Study Duration: 12 weeks, with the option to continue for another 12 weeks (up to 24 weeks)

Treatment Received:

All study participants will randomly receive either the study medication with the active ingredient or placebo for the first 12 weeks (2/3 likelihood of receiving study medication with active ingredient). Those study participants who complete the first 12 weeks of the study and wish to continue for another 12 weeks will receive study medication with the active ingredient (no one will receive placebo).

Treatment Frequency: Twice weekly.

YOU MAY QUALIFY FOR THE REFLECT STUDY IF YOU:

• Are 12 years of age or older

• Have been Diagnosed with Lamellar Ichthyosis

• Have Moderate to Severe Lamellar Ichthyosis

Additional study details, frequently asked questions, and contact information are available on the study website:

ICHTHYOSISSTUDY.COM