133 Cost-effectiveness of botulinum neurotoxin A versus surgery for drooling: a randomized clinical trial 6 METHODS This, partly single-blinded, analysis of cost-effectiveness was part of a RCT conducted between April 2012 and August 2017 approved by an independent regional ethics committee (‘Commissie Mensgebonden Onderzoek regio Arnhem – Nijmegen’). A detailed report of the trial and study design, participants, intervention protocols, and masking was previously published.10 Partly single-blinded meant that we blinded researchers to the objective outcome but not to the subjective outcome. This RCT was approved by an independent regional ethics committee (‘Commissie Mensgebonden Onderzoek regio Arnhem – Nijmegen’) and was registered in the Dutch Trial Register (trialregister.nl identifier NTR3537). Written informed consent was received from all caregivers of the patients in the study. Participants Inclusion criteria were a diagnosis of cerebral palsy or other neurological nonprogressive disorder, an age of 8 years or older, and severe drooling which was qualified as a drooling frequency ≥ 3 or a drooling severity ≥ 2. Drooling severity scores were 1, none; 2, mild; 3, moderate; 4, severe; 5, profuse; drooling frequency scores were 1, never; 2, occasional; 3, frequent; 4, constant.13 For all participants, oral therapy did not offer satisfactory results or was judged to be ineffective on the basis of the intellectual capacity or physical status of the patient. Patients were excluded from participating if they had undergone previous surgery or had anatomic head or neck anomalies interfering with either treatment. Additional exclusion criteria were simultaneous treatment for drooling or suspected progressive oromotor impairment. Study participants were randomized to either two-duct ligation or a single injection with onabotulinum toxin A (25 Units in 0.9% saline per submandibular salivary gland; Botox; Allergan; Nieuwegein, the Netherlands). All procedures were conducted in an outpatient setting at the Radboud University Medical Center,
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