*2.3. Ethics Approvals*

The protocol, participant information and consent form, as well as other study-specific documents, were submitted to the Zurich-based properly constituted cantonal ethic committee (KEK) in agreement with local legal requirements for formal study approval. The decision of the KEK concerning the conduct of the study had been made in writing to the Sponsor-Investigator before commencement of this study. The KEK decided the trial could be conducted without its approval, as the law for human research was judged to be not applicable. From an ethical perspective, the extension study was considered the same and was conducted without particular approval of the KEK. However, both studies were conducted in accordance with ICH/GCP Guidelines and registered with CLINICALTRIALS.gov as NCT03089788.

The Veterinary Offices of the participating cantons Zurich, Zug and Aargau approved the animal study ZH245/16 (19th March 2016). All cat owners signed informed consent for their cats. All interventions and examinations performed by the study veterinarians were in accordance to the Swiss Animal Welfare Ordinance and Animal Welfare Act on Animal Experimentation (2005, TSchG; 2008, TschV). The animal study was designed as an open-label, non-placebo controlled, multi-center, tolerability and immunogenicity study.
