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Background: Year-round control of canine flea and tick infestations requires owner compliance with recommendations for regular treatments. Compliance failures can result in increased exposure of dogs to tick-borne pathogens and resurgence of flea populations. This study investigated the year-long efficacy of fluralaner 150 mg/ml injectable suspension (BRAVECTO ® injectable), developed to remove the need for multiple owner-administered, within-year treatments., Methods: This randomized, examiner-masked, non-inferiority study enrolled household dogs at veterinary clinics in Germany, France, and Spain. Each household contained a primary dog infested with ≥ 4 ticks or ≥ 5 fleas. Additional dogs in each household received the same treatment as the primary dog, either a single injection with fluralaner (15 mg/kg) on day 0, or 12 monthly treatments with oral afoxolaner (NexGard ® ) beginning on day 0. Owners presented their dogs for tick and flea assessments at visits 2 through 10 (days 14, 28, 56, 84, 112, 224, 280, 336, 365). Primary endpoints were the percentages of primary dogs free of live ticks or fleas at visit 10. Secondary endpoints were the percentage reductions of live ticks and fleas in primary dogs. All treated dogs were observed for adverse reactions throughout the study., Results: The analyzed per-protocol population included 415 primary dogs (fluralaner 279, afoxolaner 136) from 976 treated dogs (fluralaner 653, afoxolaner 323). From visits 2 through 10, ≥ 95% of primary dogs in each group were tick-free, and ≥ 93% were flea-free. The percentage of dogs free of ticks or fleas was non-inferior (P ≤ 0.0048) in the fluralaner group compared to the afoxolaner group at visit 10 and all earlier visits. Compared to baseline, fluralaner-group tick and flea counts were reduced by > 99%; afoxolaner-group tick and flea counts by > 98% and > 97%, respectively. There were no unexpected adverse events in any treated dog in either group, nor any sign of interactions between concomitantly administered vaccines and medications., Conclusions: A single subcutaneous fluralaner injection provided a level of tick and flea control equivalent to that of 12 monthly administrations of afoxolaner. The sustained fluralaner efficacy helps maintain canine health by retaining treatment with the veterinarian and eliminating treatment-compliance failures by pet owners between veterinary visits., Competing Interests: Declarations. Ethics approval and consent to participate: This study was conducted in compliance with local and national regulations. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)