Molina 2004.

Methods	Design: randomised controlled trial (2 arms). Multicentre study: no. International: 1 country, Ecuador. Follow‐up period: 4 weeks (+/‐ 1). Per‐protocol analysis: no. Intention‐to‐treat analysis: no
Participants	N = enrolled and randomised pregnant women 20. Experimental group: n = 10 (ambroxol (EG)). Control group: n = 10 (no treatment(CG)). 20 participants completed study and analysed (10 women EG group/10 women CG group). 1.‐ Gestational age (calculated weeks): EG/CG group: 28 to 32 (+/‐ 1). 2.‐ Lamellar body concentration (cells/µl): EG group: 26,455 (+/‐ 8197) CG group: 16,600 (+/‐ 2797) 3.‐ Inclusion criteria: Pregnant women in their third trimester. Residents in Quito and attending a prenatal clinic. 4.‐ Exclusion criteria: Not mentioned.
Interventions	1. Experimental group: (ambroxol) was given 30 mg every 8 hours from 28 until 32 +/‐ 1 weeks. 2. Control group: (no drug). Co‐intervention: At 32 +/‐ 1 week, they took a sample of 3 to 4 cc of amniotic fluid by ultrasound‐guided amniocentesis; centrifuged the sample for 5 minutes at 276 turns per minute and then measured lamellar body concentration with automatic counting machine. Treatment duration: 4 weeks +/‐ 1.
Outcomes	Primary: Lamellar body concentration in amniotic fluid.
Notes	1.‐ A priori sample size estimation:  no. 2.‐ Sponsor: not reported. 3.‐ Role of sponsor: not reported. 4.‐ Conflict of interest: not reported. 5.‐ Number of clinical trial: not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "We conducted a prospective, randomised, open blind clinical study" (page 2177). Comment: insufficient information to permit judgment of 'Low risk' or 'High risk'.
Allocation concealment (selection bias)	Unclear risk	Quote: "We conducted a prospective, randomised, open blind clinical study" (page 2177). Comment: insufficient information to permit judgment of 'Low risk' or 'High risk'.
Blinding of participants and personnel (performance bias)	High risk	Quote: "We conducted a prospective, randomised, open blind clinical study" (page 2177).
Blinding of outcome assessment (detection bias)	Low risk	Quote: "the amniotic fluid was determined with an automatic count machine (Baker System 9120 AX, Biochem Immunosystem)" (page 2177). Comment: due the way in which the samples were analysed by an automatic instrument, we have thought it likely that they were blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: data for primary outcome available for 100% of the randomised sample
Selective reporting (reporting bias)	Low risk	Comment: all the outcomes listed in the method section described in results.
Other bias	Low risk	Comment: no other potential source of bias.