Borowitz 2005.

Methods	Randomised, double‐blind, 3‐arm parallel, dose‐ranging, multicentre study. Duration: 29 days. Participants recruited from 26 CF Foundation‐accredited centres in the USA. Home setting.
Participants	139 participants with previously diagnosed CF and undergoing treatment were screened and 129 enrolled as intention‐to‐treat population. Age: mean (SD) 21.5 (8.5) years. Gender split: 71% were males.
Interventions	Group 1: Altu‐135 5000 units of lipase. Group 2: Altu‐135 25,000 units of lipase. Group 3: Altu‐135 100,000 units of lipase. Doses were not adjusted on basis of weight or food ingested, but were fixed per meal or snack. Lipase, protease & amylase were in a ratio of 1:1:0.15
Outcomes	CFA, CNA, adverse events, QoL using the CFQ‐R.
Notes	The CFA and CNA were measured at baseline and at 14 days after randomization.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Described as randomized, but further information not given.
Allocation concealment (selection bias)	Unclear risk	Information not given.
Blinding of participants and personnel (performance bias) Participants	Low risk	All participants received equal number of unlabelled capsules.
Blinding of participants and personnel (performance bias) Clinicians	Unclear risk	Information not given.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Information not given.
Incomplete outcome data (attrition bias) All outcomes	Low risk	129 participants were enrolled as intention‐to‐treat population, of whom 12 withdrew (4 due to gastrointestinal adverse events); 117 participants who received at least 1 dose were included in a modified intention‐to‐treat analysis.
Selective reporting (reporting bias)	Low risk	All expected outcomes were reported.
Other bias	High risk	Trial sponsored and actively supported by Altus Pharmaceuticals.