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. Author manuscript; available in PMC: 2020 Aug 1.
Published in final edited form as: Laryngoscope. 2018 Dec 25;129(8):1882–1890. doi: 10.1002/lary.27695

Table 1:

Timeline and study procedures.

Time Week 1 Weeks 2-4 Weeks 5-6 Week 7 Weeks 8-10 Week 11
Procedures Qualifying assessments 3 weeks at full drug dosing Drug dosing lowered, then withdrawn 3 weeks at full drug dosing Drug dosing lowered, then withdrawn
Initial questionnaires 2 week drug washout period
Pre-intervention nurse visit (#1/4) Nurse visit in first week of full dosing, drug 1 (#2/4) Nurse visit in first week of full dosing, drug 2 (#3/4) Post-intervention nurse visit (#4/4)
Baseline testing sessions 1, 2, & 3 for drug 1 Post-testing sessions 1 & 2 at 16 mg/kg dose Baseline testing sessions 1, 2, & 3 for drug 2 Post-testing sessions 1 & 2 at 16 mg/kg dose
Drug step-up Post-testing session 3 at 32 mg/kg dose Drug step-up, then full dosing drug 2 Post-testing session 3 at 32 mg/kg dose
Phase Drug 1 at 16 mg/kg dose Drug 1 Cross-over to drug 2 at 16 mg/kg dose Drug 2
(Placebo or octanoic acid) (Placebo or octanoic acid) (Placebo or octanoic acid) (Placebo or octanoic acid)