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Drug dosing lowered, then withdrawn |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Drug dosing lowered, then withdrawn |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