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Households were randomised in a 2:1 ratio to receive either the combination investigational product (IP, Credelio Plus<jats:sup>\u00ae<\/jats:sup> tablets) or the control product (CP: Nexgard Spectra<jats:sup>\u00ae<\/jats:sup> tablets). Dogs were administered IP (flea cohort <jats:italic>n<\/jats:italic>\u2009=\u2009135; tick cohort: <jats:italic>n<\/jats:italic>\u2009=\u2009147) or CP (flea cohort: <jats:italic>n<\/jats:italic>\u2009=\u200967; tick cohort: <jats:italic>n<\/jats:italic>\u2009=\u200974) once every 4 weeks for a total of three times at a dose rate of 20.0\u201341.5\u00a0mg\/kg bodyweight lotilaner and 0.75\u20131.53\u00a0mg\/kg bodyweight milbemycin oxime (IP) or as recommended (CP). Percentage reduction was calculated by comparing individual dog flea and tick counts at each assessed post-treatment time point to their respective baseline (pre-treatment) infestation. Resolution of the clinical signs of flea allergy dermatitis (FAD) was assessed in flea-allergic dogs on the days that flea counts were performed.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Flea effectiveness of Credelio Plus<jats:sup>\u00ae<\/jats:sup> after 3 consecutive monthly treatments was 100% against <jats:italic>Ctenocephalides felis<\/jats:italic>, <jats:italic>C. canis<\/jats:italic> and <jats:italic>Pulex irritans<\/jats:italic>. Tick effectiveness of Credelio Plus<jats:sup>\u00ae<\/jats:sup> over the same time frame was 99.3% for <jats:italic>Ixodes ricinus<\/jats:italic> and 100% against <jats:italic>Rhipicephalus sanguineus<\/jats:italic> (<jats:italic>s.l.<\/jats:italic>). Flea effectiveness of the CP after three consecutive monthly treatments was 100% against <jats:italic>C. felis<\/jats:italic>, <jats:italic>C. canis<\/jats:italic> and <jats:italic>P. irritans<\/jats:italic>. Tick effectiveness of the CP over the same time frame was 99.8% for <jats:italic>I. ricinus<\/jats:italic> and 100% against <jats:italic>R. sanguineus<\/jats:italic>. Credelio Plus<jats:sup>\u00ae<\/jats:sup> was well tolerated based on the safety assessments in all treated dogs in this field study. Within both treatment groups there was a reduction in total FAD scores from baseline.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>This pivotal European field study demonstrated the excellent effectiveness and safety of a combination of lotilaner and milbemycin oxime (Credelio Plus<jats:sup>\u00ae<\/jats:sup>) administered orally to dogs naturally infested with fleas and\/or ticks.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Graphical Abstract<\/jats:title>\n                \n              <\/jats:sec>","DOI":"10.1186\/s13071-021-04808-0","type":"journal-article","created":{"date-parts":[[2021,6,4]],"date-time":"2021-06-04T14:23:44Z","timestamp":1622816624000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Field study to investigate the effectiveness and safety of a novel orally administered combination drug product containing milbemycin oxime and lotilaner (Credelio\u00ae Plus) against natural flea and tick infestations on dogs presented as veterinary patients in Europe"],"prefix":"10.1186","volume":"14","author":[{"given":"Sophie","family":"Forster","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Wiseman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4091-6297","authenticated-orcid":false,"given":"Daniel E.","family":"Snyder","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,6,4]]},"reference":[{"key":"4808_CR1","unstructured":"European Scientific Counsel Companion Animal Parasites. 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Participating dog owners were required to sign an informed consent form for their dog(s) to participate in the study after details of the study design and products under investigation had been explained.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"These studies were funded by Elanco Animal Health. All authors are current or former employees of Elanco Animal Health. The handling editors have been involved in consulting services (Filipe Dantas-Torres), research projects (Pablo Jes\u00fas Borr\u00e1s, Filipe Dantas-Torres, Adnan Hod\u017ei\u0107) and meetings (Filipe Dantas-Torres) sponsored by different veterinary pharmaceutical companies in the past 10\u00a0years, including Elanco. They declare\u00a0that each\u00a0manuscript in this collection was handled impartially and peer reviewed rigorously by at least two independent external reviewers.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"299"}}