<qa>  What is a risk to the patients well-being?7. Any medical disability e.g., peptic ulcer disease, severe degenerative arthritis, compromised nutritional state or laboratory abnormality e.g., serum creatinine 2.0 mgdL that may interfere with the protocol-specified safety and efficacy measurements, present an unacceptable risk to the patients well-being, or compromise the patients ability to provide informed consent. 