Skip to main content

Table 1 Ethic committee approvals

From: Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell®)

Study

Ethical Committee

- single-dose, comparing 1 and 2 mg lozenges with 2 mg gum

- multiple-dose, comparing 1 mg lozenge with 2 mg gum

CCPPRB de Franche-Comté, France

- multiple-dose, comparing 1 and 2 mg lozenges with 4 mg gum

CCPPRB of the Hôtel-Dieu Hospital (Lyon – France)

- safety assessment of 1 mg lozenge after swallowing

CREC Regipharm (Brussels – Belgium)

- French efficacy trial

CCPPRB of the Pitié-Salpêtrière Hospital (Paris – France)

- US efficacy trial

IRB at Research Testing Laboratories, Inc. (Great Neck, NY, USA)