Ethics statement
ICH
The study was conducted in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines on good clinical practice (GCP), applicable regulations governing clinical study conduct and the ethical principles that have their origin in the Declaration of Helsinki. As per GCP, an institutional review board, Quorum (approval number: 32868/1), ensured the ethical, scientific, and medical appropriateness of the study before it was initiated and approved all relevant documentation.Written informed consent was obtained from all subjects before undertaking any study-related procedures.The study was conducted under the direction of AbbVie, who was responsible for study monitoring and flubentylosin concentration assays (blood and urine). Clinical laboratory tests and safety data management were performed by contract research organizations (Chicago Clinical Laboratories Ltd, Northbrook IL USA and Syneos Health, Morrisville NC USA).