Randomised clinical trial: the efficacy and safety of pancreatin enteric-coated minimicrospheres (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis--a double-blind, placebo-controlled study.

"The authors thank the following for their assistance: Dr Anita Bijoor, Department of Biochemistry and Biophysics, St John's Medical College, Bangalore, India for analysis of stool samples; personnel at Quintiles India; and the study team at Lakeshore hospital: Manish Gandhi, Mahesh Subramaniaiyer, and Asha S. Nair. Declaration of personal interests : Vinay Thorat, Nageshwar Reddy, Amol Bapaye, JS Rajkumar, Dinesh Kini and Mukesh Kalla have has no relevant conflicts of interest to disclose. Shobna Bhatia has received research funding (paid to institution) from Pfizer and Solvay (now Abbott). Hariharan Ramesh has participated in an advisory board for Pfizer Medical and Research Division on improving outcomes in Candida infections in liver transplant patients, has participated as a speaker in a symposium on pancreatic exocrine insufficiency for Abbott, and has had travel/accommodation expenses covered or reimbursed by Abbott and Dr Reddy's Laboratories Ltd. Declaration of funding interests : This study was funded in full by Abbott. Initial data analyses were undertaken by DATAMAP GmbH, funded by Abbott. Medical writing support was provided by Helen Varley, PhD, of Envision Scientific Solutions, Horsham, UK and funded by Abbott."

"The authors thank the following for their assistance: Dr Anita Bijoor, Department of Biochemistry and Biophysics, St John's Medical College, Bangalore, India for analysis of stool samples; personnel at Quintiles India; and the study team at Lakeshore hospital: Manish Gandhi, Mahesh Subramaniaiyer, and Asha S. Nair. Declaration of personal interests: Vinay Thorat, Nageshwar Reddy, Amol Bapaye, JS Rajkumar, Dinesh Kini and Mukesh Kalla have has no relevant conflicts of interest to disclose. Shobna Bhatia has received research funding (paid to institution) from Pfizer and Solvay (now Abbott). Hariharan Ramesh has participated in an advisory board for Pfizer Medical and Research Division on improving outcomes in Candida infections in liver transplant patients, has participated as a speaker in a symposium on pancreatic exocrine insufficiency for Abbott, and has had travel/accommodation expenses covered or reimbursed by Abbott and Dr Reddy's Laboratories Ltd. Declaration of funding interests: This study was funded in full by Abbott. Initial data analyses were undertaken by DATAMAP GmbH, funded by Abbott. Medical writing support was provided by Helen Varley, PhD, of Envision Scientific Solutions, Horsham, UK and funded by Abbott."

"This was a 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study to assess the efficacy and safety of pancreatin 40000 MMS (ClinicalTrials.gov number NCT00705978) that was conducted at 11 centres in India; nine centres contributed patients. The study was conducted in compliance with EU Clinical Trial Directive 2001/20/EC, the International Conference on Harmonization guideline for Good Clinical Practice, and the ethical principles of the Declaration of Helsinki, and was approved by an independent ethics committee that complied with local regulatory requirements. Voluntary written consent was obtained from all subjects before screening."