Rescue treatments
If medically necessary (that is, to control intolerable PN symptoms), rescue treatment for PN was provided to study patients at the discretion of the investigator. Although the use of rescue medications was allowed at any time during the study, the use of such medications was delayed, if possible, for at least 14 days after the initiation of the investigational treatment. The date and time of rescue medication administration, as well as the name and dosage regimen of the rescue medication, was recorded in the eCRF. For the efficacy responder analysis, a pre-specified algorithm was used to classify rescue. In addition, a blinded review of all post-baseline medications, based on medical judgment, was performed to adjudicate rescue treatment. Patients who received rescue treatment as per this adjudication during the study were considered as having treatment failure.Dermatological preparations of high-potency or super-potent TCS and TCI could be used as rescue medications.