Patient Unblinding. Although there is no known antidote to bardoxolone methyl, under rare circumstances unblinding may be considered medically necessary. The investigator is strongly encouraged to contact the medical monitor to discuss situations in which he or she believes that the blind should be broken, but ultimately the investigator has the right to break the blind (e.g., in the event of a serious or life-threatening medical situation). If unblinding is required, the investigator will utilize the IWRS to perform the unblinding. If a study drug assignment is unblinded, the investigator must describe the event that required unblinding in the patient’s source documents. Patients must discontinue taking study drug if their treatment assignment has been unblinded to the investigator (or designee). Such patients must undergo the same study drug discontinuation procedures as those patients who discontinue taking study drug for other reasons. Patient treatment assignments must not be unblinded in the case of an AE or SAE, except as described above.
