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Table 5 Clinical findings in dogs of treated and control groups following the first treatment

From: Safety of fluralaner chewable tablets (BravectoTM), a novel systemic antiparasitic drug, in dogs after oral administration

Observation

Number of dogs affected

Analysis

Conclusion

Scattered incidences of abnormal feces (loose, mucoid, traces of fresh blood)

Total observed: n = 15

Similar number of animals affected in each treated group compared to controls; abnormal feces already observed pre-treatment across all groups

Not treatment related, no adverse event

Control group: n = 4

1X group: n = 5

3X group: n = 3

5X group: n = 3

Reduced body condition score (2 or 2–3 on a scale of 1–5)

Total observed: n = 8

Similar (3X group, 5X group) or lower (1X group) number of animals affected compared to controls; no dose–response relationship

Not treatment related, no adverse event

Control group: n = 3

1X group: n = 0

3X group: n = 3

5X group: n = 2

Localized hair thinning/pressure wound/wound

Total observed: n = 6

Similar (1X group, 5X group) or lower (3X group) number of animals affected compared to controls; no dose–response relationship

Not treatment related, no adverse event

Control group: n = 2

1X group: n = 3

3X group: n = 0

5X group: n = 1

Vomiting of food after first treatment, no other clinical findings

Total observed: n = 1

Single case; no dose–response relationship; not observed following repeated treatment

Not treatment related, no adverse event

Control group: n = 0

1X group: n = 1

3X group: n = 0

5X group: n = 0

Gastroenteritis with inappetence, dullness, vomit

Total observed: n = 1

Single case; no dose–response relationship; not observed following repeated treatment

Not treatment related, no adverse event

Control group: n = 0

1X group: n = 0

3X group: n = 1

5X group: n = 0