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Suggested Consent Language: Drugs

ORI

Procedure Language

Copy/Paste the following to the section labeled B. Procedures:

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Risk Language

Copy/Paste the following to the section labeled D. Risks/Discomforts:

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While you take part in this study, you may be at risk for side effects that may be mild, moderate or severe. You should discuss these with your doctor.

Many side effects go away shortly after the treatment stops, but occasionally, side effects can be serious, long lasting, or permanent. It is not possible to tell which side effect will affect you or how mild or severe the side effect might be. We can only tell you what other people have experienced.

It is very important that you notify your study doctor right away about any side effects, problems, or unusual experiences you may have while taking the medication involved with this study. This will decrease the chance that the side effects continue or become worse. Sometimes there are other medications that we can give you to make lessen the side effects or make you more comfortable.

Study Drug Name may cause some, all or none of the side-effects listed below:

More Likely (X percent to Y percent):

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Less Likely (X percent to Y percent): 

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Rare (less than or equal to X percent) :

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There may be other side effects of the drugs that we do not know of yet.