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excursions permitted to 59F to 86F (15C to 30C) [see USP Controlled Room Temperature]

Vocal cord nodules are much more common in women than men

One alternative schedule begins at 0.6 mg, escalating every two weeks through 1.2 mg and 2.4 mg to reach 4.5 mg

The protocols and the subject information/informed consent forms were reviewed and approved by an independent ethics committee (Ethik-Kommission des Landes Berlin) and by appropriate health authorities according to local regulations