2.1. Study Design

This phase 1, randomized, single-center, single-blind, ascending dose-escalation, fixed-sequence study with IH oxytocin ({"type":"clinical-trial","attrs":{"text":"NCT02542813","term_id":"NCT02542813"}}NCT02542813) was conducted at the GSK Clinical Unit Cambridge, Addenbrooke's Centre for Clinical Investigation (Addenbrooke's Hospital, UK). Ethical approval for the study was obtained from the Office for Research Ethics Committees Northern Ireland. The study was conducted in accordance with International Conference on Harmonisation Good Clinical Practice, all applicable subject privacy requirements, and the ethical principles outlined in the Declaration of Helsinki 2013. The full protocol can be accessed at https://gsk-clinicalstudyregister.com/search/ps/1/?study_ids=201558.