. Author manuscript; available in PMC: 2019 Jan 1.

Published in final edited form as: Eur J Pharm Sci. 2018 Jun 19;126:33–48. doi: 10.1016/j.ejps.2018.06.011

Table 1.

Study design for the rat single dose safety study.

	Group A	Group B	Group C	Group D
	Saline	Standard-of-care	Particles + magnet	Particles + prednisolone + magnet
Ears to be treated	in one ear	in one ear	in one ear	in one ear
Number of animals	N =12	N =12	N =12	N =12
Day of treatment	Measure hearing by ABR at rat hearing frequencies (8, 12, 16, 24, 32 kHz)
Treatment	Intra-tympanic saline	Intra-tympanic prednisolone	Intra-tympanic drug-free particles, then apply magnet	Intra-tympanic particles with prednisolone, then apply magnet
2 days after treatment	Measure hearing by ABR at rat hearing frequencies (8, 12, 16, 24, 32 kHz)
2 days after treatment	Terminate 50% (N = 6) animals per group. Measure iron, drug in ear and major organs. Ear histology.
1 month after treatment	Measure hearing by ABR at rat hearing frequencies (8, 12, 16, 24, 32 kHz)
1 month after treatment	Terminate remaining 50% (N = 6) animals per group. Measure iron, drug in ear, major organs. Ear histology.